Zoladex

Cytostatic Gonadotropin-Releasing Hormone Agonists
Gonadotropin-Releasing Hormone Agonists

Hazardous Drugs Classification
NIOSH 2016 List: Group 1
NIOSH (Draft) 2020 List: Table 2
Observe and exercise appropriate precautions for handling, preparation, administration, and disposal of hazardous drugs.
Use double chemotherapy gloves and a protective gown. Prepare in a biological safety cabinet or compounding aseptic containment isolator with a closed system drug transfer device. Eye/face and respiratory protection may be needed during preparation and administration.

Injectable Administration Subcutaneous Administration

Examine the foil pouch and syringe for damage. Remove the syringe from the opened foil pouch and hold the syringe at a slight angle to the light. Check that at least part of the goserelin implant is visible.
Unlike liquid injections, there is no need to remove air bubbles. Attempts to do so may displace the goserelin implant.
The syringe cannot be used for aspiration. If the needle penetrates a large blood vessel, blood will instantly be seen in the syringe chamber; withdraw the needle and inject elsewhere with a new syringe.
NOTE: In the unlikely event of the need to surgically remove the goserelin implant, it may be localized by ultrasound.
 
Administration
Place the patient in a comfortable position with the upper part of the body slightly raised.
Prepare an area of the anterior abdominal wall below the navel line with an alcohol swab.
Pull the red plastic safety tab away from the syringe and discard it. Remove the needle cover.
Hold the syringe around the protective sleeve. Using aseptic technique, pinch the skin of the patient's anterior abdominal wall below the navel line. Use caution due to the proximity of the underlying inferior epigastric artery and its branches.
With the bevel of the needle facing up, insert it at a 30- to 45-degree angle to the skin in one continuous deliberate motion until the protective sleeve touches the patient's skin. Do not penetrate into muscle or peritoneum.
Grasp the barrel at the finger grip and depress the plunger until you cannot depress it any further to activate the protective sleeve and administer the implant; the sleeve will click, and then automatically begin to slide to cover the needle. If the plunger is not fully depressed, the protective sleeve will not activate. The needle does not retract.
Withdraw the needle and allow the protective sleeve to slide and cover the needle. Dispose of the syringe in an approved sharps container.

Severe

myocardial infarction / Delayed / 0-5.0
heart failure / Delayed / 0-5.0
pulmonary embolism / Delayed / 0-5.0
stroke / Early / 0-5.0
hematemesis / Delayed / 0-5.0
peptic ulcer / Delayed / 1.0-5.0
new primary malignancy / Delayed / 0-5.0
suicidal ideation / Delayed / Incidence not known
visual impairment / Early / Incidence not known
pituitary apoplexy / Early / Incidence not known
bone fractures / Delayed / Incidence not known
ovarian hyperstimulation syndrome / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
renal failure (unspecified) / Delayed / Incidence not known
spinal cord compression / Delayed / Incidence not known
thrombosis / Delayed / Incidence not known
seizures / Delayed / Incidence not known

Moderate

hot flashes / Early / 47.0-96.0
vaginitis / Delayed / 1.0-75.0
peripheral vasodilation / Rapid / 0-57.0
depression / Delayed / 1.0-54.0
tumor flare / Delayed / 0-23.0
peripheral edema / Delayed / 0-21.0
impotence (erectile dysfunction) / Delayed / 0-18.0
dyspareunia / Delayed / 0-14.0
vaginal bleeding / Delayed / 0-7.0
migraine / Early / 1.0-7.0
edema / Delayed / 1.0-7.0
hypertension / Early / 1.0-6.0
bone pain / Delayed / 0-6.0
constipation / Delayed / 1.0-5.0
chest pain (unspecified) / Early / 1.0-5.0
angina / Early / 0-5.0
hyperglycemia / Delayed / 0-5.0
diabetes mellitus / Delayed / 0-5.0
urinary retention / Early / 0-5.0
urinary incontinence / Early / 0-5.0
bleeding / Early / 0-5.0
hematuria / Delayed / 0-5.0
amblyopia / Delayed / 1.0-5.0
gout / Delayed / 1.0-5.0
dyspnea / Early / 0-5.0
anemia / Delayed / 0-5.0
hypertonia / Delayed / 0-1.0
elevated hepatic enzymes / Delayed / 0-1.0
palpitations / Early / 1.0
sinus tachycardia / Rapid / 1.0
psychosis / Early / Incidence not known
hematoma / Early / Incidence not known
osteopenia / Delayed / Incidence not known
osteoporosis / Delayed / Incidence not known
hyperlipidemia / Delayed / Incidence not known
hypotension / Rapid / Incidence not known
QT prolongation / Rapid / Incidence not known
antibody formation / Delayed / Incidence not known
proctitis / Delayed / Incidence not known
cystitis / Delayed / Incidence not known
hypercalcemia / Delayed / Incidence not known

Mild

headache / Early / 1.0-75.0
libido decrease / Delayed / 0-61.0
emotional lability / Early / 0-60.0
acne vulgaris / Delayed / 0-42.0
seborrhea / Delayed / 0-26.0
breast enlargement / Delayed / 0-18.0
infection / Delayed / 1.0-13.0
abdominal pain / Early / 1.0-11.0
asthenia / Delayed / 0-11.0
nausea / Early / 5.0-11.0
insomnia / Early / 0-11.0
pelvic pain / Delayed / 0-9.0
gynecomastia / Delayed / 0-8.0
lethargy / Early / 0-8.0
mastalgia / Delayed / 0-7.0
back pain / Delayed / 1.0-7.0
dysmenorrhea / Delayed / 0-7.0
hirsutism / Delayed / 0-7.0
injection site reaction / Rapid / 0-6.0
rash / Early / 0-6.0
pruritus / Rapid / 0-6.0
pharyngitis / Delayed / 0-6.0
dizziness / Early / 1.0-6.0
flatulence / Early / 1.0-5.0
diarrhea / Early / 1.0-5.0
anxiety / Delayed / 1.0-5.0
skin discoloration / Delayed / 0-5.0
xerosis / Delayed / 0-5.0
sinusitis / Delayed / 0-5.0
rhinitis / Early / 0-5.0
chills / Rapid / 0-5.0
influenza / Delayed / 1.0-5.0
fever / Early / 1.0-5.0
increased urinary frequency / Early / 0-5.0
malaise / Early / 0-5.0
fatigue / Early / 0-5.0
drowsiness / Early / 0-5.0
epistaxis / Delayed / 0-5.0
ecchymosis / Delayed / 0-5.0
arthralgia / Delayed / 0-5.0
xerophthalmia / Early / 1.0-5.0
dyspepsia / Early / 0-5.0
vomiting / Early / 1.0-5.0
xerostomia / Early / 0-5.0
weight gain / Delayed / 1.0-5.0
anorexia / Delayed / 1.0-5.0
alopecia / Delayed / 0-5.0
paresthesias / Delayed / 1.0-5.0
cough / Delayed / 1.0-5.0
menorrhagia / Delayed / 0-4.0
myalgia / Early / 0-3.0
muscle cramps / Delayed / 0-2.0
appetite stimulation / Delayed / 0-2.0
irritability / Delayed / Incidence not known
diaphoresis / Early / Incidence not known

Zoladex, Zoladex 3-Month

Rx

A synthetic gonadotropin-releasing hormone (GnRH) agonist
Used for the palliative treatment of advanced prostate cancer or breast cancer, for the management of endometriosis, dysfunctional uterine bleeding, and the adjunct medical management of uterine fibroids
A transient tumor flare may occur during the first few weeks of treatment, which may cause ureteral obstruction and spinal cord compression; monitor patients at risk for these complications

For the treatment of breast cancer. For the palliative treatment of advanced breast cancer in pre- or perimenopausal women.
NOTE: The estrogen and progesterone receptor values may help to predict whether goserelin therapy is likely to be beneficial.
Subcutaneous dosage Adult females

3.6 mg injected subcutaneously into the anterior abdominal wall below the navel line every 28 days; goserelin is intended for long-term use unless clinically inappropriate. Coadministration of certain drugs may need to be avoided; review drug interactions. Treatment with goserelin resulted in a best objective response of 22% in premenopausal women with advanced ER- or PR-positive breast cancer compared with 12% in patients who received an oophorectomy; the median time to treatment failure was 6.7 months versus 5.5 months, respectively. The median survival time was 33.2 months in patients treated with goserelin compared with 33.6 months in those who received an oophorectomy. Objective responses were seen regardless of estrogen-receptor (ER) status in uncontrolled clinical trials, with a response rate of 36% in ER-positive patients, 10% to 18% in ER-negative patients, and 26% to 41% in patients with an unknown ER status.

For the adjuvant treatment of estrogen receptor (ER)-positive breast cancer in premenopausal women†. Subcutaneous dosage Adult females

3.6 mg injected subcutaneously into the anterior abdominal wall below the navel line every 28 days. Coadministration of certain drugs may need to be avoided; review drug interactions. After a median follow-up of 6 years, adjuvant treatment with goserelin for 2 years was equivalent to treatment with cyclophosphamide, methotrexate, and fluorouracil (CMF) for disease-free survival (DFS) in premenopausal patients with node-positive, ER-positive breast cancer (HR 1.01) in a randomized, open-label trial (the ZEBRA trial); in ER-negative patients, goserelin was inferior to CMF for DFS (HR 1.76). After a median of 12 years' follow-up from another randomized, open-label trial of premenopausal women with early breast cancer (the ZIPP trial), adjuvant treatment with goserelin for 2 years resulted in a 33% reduction in the risk of having an event-free survival event, a 29% reduction in risk of overall mortality, a 34% reduction in risk of recurrence, and a 29% reduction in risk of breast cancer mortality compared with patients receiving no endocrine therapy; goserelin was as effective as tamoxifen when each is given for 2 years. In this study, the effect of goserelin was greatest in women who were node-negative and ER-positive.

For the treatment of endometriosis, including pain relief and reduction of endometriotic lesions. Subcutaneous dosage (Zoladex 3.6 mg monthly Implant ONLY) Adult females

3.6 mg injected subcutaneously into the anterior abdominal wall below the navel line every 28 days for 6 months. Coadministration of certain drugs may need to be avoided; review drug interactions. Safety data for retreatment are not available; therefore, retreatment cannot be recommended. If endometriosis symptoms recur and retreatment with goserelin is contemplated, consider monitoring bone mineral density. In a controlled clinical trial, more patients treated with goserelin had a 50% or more reduction in the extent of endometrial lesions (63% vs. 42%); in another study, a reduction in the extent of endometrial lesions of 50% or more occurred in 62% versus 51% of patients, respectively. The clinical significance of a decrease in endometriotic lesions is not known; laparoscopic staging of endometriosis does not necessarily correlate with the severity of symptoms. In these studies, clinical symptoms were significantly reduced within 4 weeks of beginning therapy and were reduced by an average of 84% by the end of treatment.

For use as an endometrial thinning agent prior to endometrial ablation for dysfunctional uterine bleeding. Subcutaneous dosage Adult females

3.6 mg injected subcutaneously into the anterior abdominal wall below the navel line; a second 3.6 mg subcutaneous injection may be administered 4 weeks later if necessary. If one injection is given, schedule surgery 4 weeks after administration. If two injections are given, surgery should be performed within 2 to 4 weeks after administration of the second dose. Coadministration of certain drugs may need to be avoided; review drug interactions. The median endometrial thickness before surgery was significantly less in premenopausal women treated with goserelin compared to the placebo group (1.5 mm vs. 3.55 mm) in a randomized clinical trial; amenorrhea occurred in 40% of patients in the goserelin arm 6 months after surgery, compared with 26% of those in the placebo arm. In a single-center, open-label trial, median endometrial thickness before surgery was significantly less in the group treated with two injections compared to the group treated with one injection (0.5 mm vs. 1 mm); there was no difference in the incidence of amenorrhea at 24 months.

For the treatment of prostate cancer. For the treatment of locally confined Stage T2b-T4 (Stage B2-C) prostate cancer, in combination with flutamide and radiation therapy. Subcutaneous dosage Adult males

3.6 mg injected subcutaneously into the anterior abdominal wall below the navel line every 28 days in combination with flutamide (250 mg PO three times daily). Alternatively, administer goserelin 3.6 mg subcutaneously once, followed in 28 days by one goserelin 10.8 mg subcutaneous injection. Begin treatment 8 weeks prior to initiating radiotherapy and continue during radiation therapy. Coadministration of certain drugs may need to be avoided; review drug interactions. In a multicenter controlled trial, treatment with goserelin and flutamide prior to and during radiation significantly decreased the rate of local failure at 4 years compared to radiation alone (16% vs. 33%) in men with bulky primary stage B2 or C prostate cancer, with or without pelvic node involvement; there was also a trend toward a reduced incidence of distant metastases (27% vs. 36%). Median disease-free survival was significantly increased in patients treated with goserelin, flutamide, and radiation compared to radiation alone (4.4 years vs. 2.6 years).

For the palliative treatment of advanced prostate cancer. Subcutaneous dosage Adult males

3.6 mg injected subcutaneously into the anterior abdominal wall below the navel line every 28 days; goserelin is intended for long-term use unless clinically inappropriate. Coadministration of certain drugs may need to be avoided; review drug interactions. Long-term endocrine responses and objective responses were similar in patients treated with goserelin compared to orchiectomy in controlled clinical trials of patients with advanced prostate cancer. Additionally, the duration of survival was similar between the 2 treatment arms in a comparative trial.

Subcutaneous dosage Adult males

10.8 mg injected subcutaneously into the anterior abdominal wall below the navel line every 12 weeks; goserelin is intended for long-term use unless clinically inappropriate. Coadministration of certain drugs may need to be avoided; review drug interactions. Long-term endocrine responses and objective responses were similar in patients treated with goserelin 3.6 mg once monthly compared to orchiectomy in controlled clinical trials of patients with advanced prostate cancer; additionally, the duration of survival was similar between the 2 treatment arms in a comparative trial. Goserelin 10.8 mg every 3 months has similar effects on the suppression of testosterone compared to goserelin 3.6 mg once monthly and is predicted to produce similar clinical outcomes.

For the treatment of uterine leiomyomata (fibroids)†. Subcutaneous dosage Adults

3.6 mg subcutaneously every 28 days. Treatment with goserelin reduces uterine size and the size of uterine leiomyomata. When used as an adjunctive pretreatment for surgical removal of fibroids, treatment with goserelin results in technically easier surgical procedures, reduced intraoperative blood loss, and reduced transfusion requirements around the time of surgery. In women with fibroids who are near menopause where the fibroids may shrink, treatment with goserelin may help avoid hysterectomy.

†Indicates off-label use

Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Adagrasib: (Major) Concomitant use of adagrasib and androgen deprivation therapy (i.e., goserelin) increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Alfuzosin: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving alfuzosin. Androgen deprivation therapy may prolong the QT/QTc interval. Alfuzosin may also prolong the QT interval in a dose-dependent manner.
Amiodarone: (Major) Avoid coadministration of amiodarone with goserelin if possible due to the risk of QT prolongation. Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks in patients receiving amiodarone. Amiodarone, a Class III antiarrhythmic agent, is associated with a well-established risk of QT prolongation and torsade de pointes (TdP), although the frequency of TdP is less with amiodarone than with other Class III agents. Androgen deprivation therapy also prolongs the QT interval. Due to the extremely long half-life of amiodarone, a drug interaction is possible for days to weeks after discontinuation of amiodarone.
Amisulpride: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with goserelin. Amisulpride causes dose- and concentration- dependent QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Amoxapine: (Major) Avoid coadministration of goserelin with amoxapine due to the risk of reduced efficacy of goserelin. Amoxapine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Amoxicillin; Clarithromycin; Omeprazole: (Major) Avoid coadministration of clarithromycin with goserelin. Clarithromycin is associated with an established risk for QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Anagrelide: (Major) Do not use anagrelide with other drugs that prolong the QT interval such as goserelin. Torsade de pointes (TdP) and ventricular tachycardia have been reported with anagrelide; in addition, dose-related increases in mean QTc and heart rate were observed in healthy subjects. Androgen deprivation therapy (e.g., goserelin) also prolongs the QT interval; the risk may be increased with the concurrent use of drugs that may prolong the QT interval.
Androgens: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Apomorphine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving apomorphine. Androgen deprivation therapy may prolong the QT/QTc interval. Dose-related QTc prolongation is associated with therapeutic apomorphine exposure.
Aripiprazole: (Moderate) Concomitant use of aripiprazole and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Arsenic Trioxide: (Major) Avoid concomitant use of arsenic trioxide with goserelin; discontinue or select an alternative drug that does not prolong the QT interval prior to starting arsenic trioxide therapy. If concomitant drug use is unavoidable, frequently monitor electrocardiograms. Torsade de pointes (TdP), QT interval prolongation, and complete atrioventricular block have been reported with arsenic trioxide use. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Artemether; Lumefantrine: (Major) Avoid coadministration of artemether with goserelin if possible due to the risk of QT prolongation. Consider ECG monitoring if goserelin must be used with or after artemether; lumefantrine treatment. Artemether; lumefantrine is associated with prolongation of the QT interval. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. (Major) Avoid coadministration of lumefantrine with goserelin if possible due to the risk of QT prolongation. Consider ECG monitoring if goserelin must be used with or after artemether; lumefantrine treatment. Artemether; lumefantrine is associated with prolongation of the QT interval. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Asenapine: (Major) Avoid coadministration of goserelin with asenapine due to the risk of reduced efficacy of goserelin as well as the risk of QT prolongation. Asenapine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Additionally, asenapine has been associated with QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Atomoxetine: (Moderate) Concomitant use of atomoxetine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Azithromycin: (Major) Avoid coadministration of azithromycin with goserelin due to the increased risk of QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. QT prolongation and torsade de pointes (TdP) have been spontaneously reported during azithromycin postmarketing surveillance. Androgen deprivation therapy may prolong the QT/QTc interval.
Bedaquiline: (Major) Frequently monitor ECGs for QT prolongation if coadministration of bedaquiline with goserelin is necessary. Bedaquiline has been reported to prolong the QT interval; coadministration with other QT prolonging drugs may result in additive or synergistic prolongation of the QT interval. Androgen deprivation therapy may also prolong the QT/QTc interval.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Moderate) Concomitant use of metronidazole and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Concomitant use of metronidazole and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Brexpiprazole: (Major) Avoid coadministration of goserelin with brexpiprazole due to the risk of reduced efficacy of goserelin. Brexpiprazole can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Buprenorphine: (Major) Concomitant use of buprenorphine and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Buprenorphine; Naloxone: (Major) Concomitant use of buprenorphine and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Cabotegravir; Rilpivirine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving rilpivirine as concurrent use may increase the risk of QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval.
Cariprazine: (Major) Avoid coadministration of goserelin with cariprazine due to the risk of reduced efficacy of goserelin. Cariprazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Ceritinib: (Major) Avoid coadministration of ceritinib with goserelin if possible due to the risk of QT prolongation. If concomitant use is unavoidable, periodically monitor ECGs and electrolytes; an interruption of ceritinib therapy, dose reduction, or discontinuation of therapy may be necessary if QT prolongation occurs. Ceritinib causes concentration-dependent QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Chloroquine: (Major) Avoid coadministration of chloroquine with goserelin due to the increased risk of QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Chloroquine is associated with an increased risk of QT prolongation and torsade de pointes (TdP); the risk of QT prolongation is increased with higher chloroquine doses. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Chlorpromazine: (Major) Avoid coadministration of goserelin with chlorpromazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Chlorpromazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Additionally, chlorpromazine, a phenothiazine, is associated with an established risk of QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Ciprofloxacin: (Moderate) Concomitant use of ciprofloxacin and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Cisapride: (Contraindicated) Because of the potential for QT prolongation and torsade de pointes (TdP), the use of goserelin with cisapride is contraindicated. Prolongation of the QT interval and ventricular arrhythmias, including TdP and death, have been reported with cisapride. Androgen deprivation therapy (e.g., goserelin) also prolongs the QT interval; the risk may be increased with the concurrent use of drugs that may prolong the QT interval.
Citalopram: (Major) Concomitant use of citalopram and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Clarithromycin: (Major) Avoid coadministration of clarithromycin with goserelin. Clarithromycin is associated with an established risk for QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Clofazimine: (Moderate) Concomitant use of clofazimine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Clomipramine: (Major) Avoid coadministration of goserelin with clomipramine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Chlorpromazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Additionally, Tricyclic antidepressants (e.g., clomipramine) share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Clozapine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving clozapine as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. Treatment with clozapine has been associated with QT prolongation, torsade de pointes (TdP), cardiac arrest, and sudden death.
Codeine; Phenylephrine; Promethazine: (Major) Avoid coadministration of goserelin with promethazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Promethazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Codeine; Promethazine: (Major) Avoid coadministration of goserelin with promethazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Promethazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Crizotinib: (Major) Avoid coadministration of crizotinib with goserelin due to the risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs for QT prolongation and monitor electrolytes. An interruption of therapy, dose reduction, or discontinuation of therapy may be necessary for crizotinib if QT prolongation occurs. Crizotinib has been associated with concentration-dependent QT prolongation. Androgen deprivation therapy (e.g., goserelin) also prolongs the QT interval; the risk may be increased with the concurrent use of drugs that may prolong the QT interval.
Danazol: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Dasatinib: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving dasatinib as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. In vitro studies have shown that dasatinib also has the potential to prolong the QT interval.
Desipramine: (Minor) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving desipramine. Tricyclic antidepressants share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Androgen deprivation therapy may also prolong the QT/QTc interval.
Deutetrabenazine: (Major) Avoid coadministration of goserelin with deutetrabenazine due to the risk of reduced efficacy of goserelin. Deutetrabenazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin-releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval. Deutetrabenazine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when deutetrabenazine is administered within the recommended dosage range.
Dexmedetomidine: (Moderate) Concomitant use of dexmedetomidine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Dextromethorphan; Quinidine: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving quinidine. Quinidine administration is associated with QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy may also prolong the QT/QTc interval.
Disopyramide: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving disopyramide. Androgen deprivation therapy may prolong the QT/QTc interval. Disopyramide administration is also associated with QT prolongation and torsade de pointes (TdP).
Dofetilide: (Major) Coadministration of dofetilide and goserelin is not recommended as concurrent use may increase the risk of QT prolongation. Dofetilide, a Class III antiarrhythmic agent, is associated with a well-established risk of QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Dolasetron: (Moderate) Consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients receiving dolasetron as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Dolasetron has been associated with a dose-dependent prolongation in the QT, PR, and QRS intervals on an electrocardiogram.
Dolutegravir; Rilpivirine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving rilpivirine as concurrent use may increase the risk of QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval.
Donepezil: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving donepezil. Androgen deprivation therapy may prolong the QT/QTc interval. Case reports indicate that QT prolongation and torsade de pointes (TdP) can occur during donepezil therapy.
Donepezil; Memantine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving donepezil. Androgen deprivation therapy may prolong the QT/QTc interval. Case reports indicate that QT prolongation and torsade de pointes (TdP) can occur during donepezil therapy.
Doxepin: (Minor) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving doxepin. Tricyclic antidepressants share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Androgen deprivation therapy may also prolong the QT/QTc interval.
Dronedarone: (Contraindicated) Because of the potential for torsade de pointes (TdP), use of goserelin with dronedarone is contraindicated. Dronedarone administration is associated with a dose-related increase in the QTc interval. The increase in QTc is approximately 10 milliseconds at doses of 400 mg twice daily (the FDA-approved dose) and up to 25 milliseconds at doses of 1,600 mg twice daily. Although there are no studies examining the effects of dronedarone in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation. Androgen deprivation therapy (e.g., goserelin) is known to prolong the QT interval.
Droperidol: (Major) Droperidol should not be used in combination with any drug known to have potential to prolong the QT interval, such as goserelin. If coadministration is unavoidable, use extreme caution; initiate droperidol at a low dose and increase the dose as needed to achieve the desired effect. Droperidol administration is associated with an established risk for QT prolongation and torsade de pointes (TdP). Some cases have occurred in patients with no known risk factors for QT prolongation and some cases have been fatal. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Efavirenz: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving efavirenz as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. Prolongation of the QTc interval has also been observed with the use of efavirenz.
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving efavirenz as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. Prolongation of the QTc interval has also been observed with the use of efavirenz.
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving efavirenz as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. Prolongation of the QTc interval has also been observed with the use of efavirenz.
Eliglustat: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving eliglustat. Androgen deprivation therapy may prolong the QT/QTc interval. Eliglustat is also predicted to cause PR, QRS, and/or QT prolongation at significantly elevated plasma concentrations.
Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving rilpivirine as concurrent use may increase the risk of QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval.
Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving rilpivirine as concurrent use may increase the risk of QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval.
Encorafenib: (Major) Avoid coadministration of encorafenib and goserelin due to the risk of QT prolongation. If concurrent use cannot be avoided, monitor ECGs for QT prolongation and monitor electrolytes; correct hypokalemia and hypomagnesemia prior to treatment. Encorafenib has been associated with dose-dependent QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Entrectinib: (Major) Avoid coadministration of entrectinib with goserelin due to the risk of QT prolongation. Entrectinib has been associated with QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Eribulin: (Major) Closely monitor ECGs for QT prolongation if coadministration of eribulin with goserelin is necessary. Eribulin has been associated with QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Erythromycin: (Major) Concomitant use of erythromycin and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Escitalopram: (Moderate) Concomitant use of escitalopram and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Esterified Estrogens; Methyltestosterone: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Fingolimod: (Moderate) Consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients receiving fingolimod as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Fingolimod initiation results in decreased heart rate and may prolong the QT interval. Fingolimod has not been studied in patients treated with drugs that prolong the QT interval, but drugs that prolong the QT interval have been associated with cases of TdP in patients with bradycardia.
Flecainide: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving flecainide. Flecainide is a Class IC antiarrhythmic associated with a possible risk for QT prolongation and/or torsade de pointes (TdP); flecainide increases the QT interval, but largely due to prolongation of the QRS interval. Androgen deprivation therapy may also prolong the QT/QTc interval. Although causality for TdP has not been established for flecainide, patients receiving concurrent drugs that have the potential for QT prolongation may have an increased risk of developing proarrhythmias.
Fluconazole: (Moderate) Concomitant use of fluconazole and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Fluoxetine: (Moderate) Concomitant use of fluoxetine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Fluphenazine: (Major) Avoid coadministration of goserelin with fluphenazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Fluphenazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Additionally, androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Fluphenazine is also associated with a possible risk for QT prolongation. Theoretically, fluphenazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation.
Fluvoxamine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving fluvoxamine. Androgen deprivation therapy may prolong the QT/QTc interval. Prolongation of the QT interval and torsade de pointes (TdP) has also been reported during fluvoxamine post-marketing use.
Foscarnet: (Major) Avoid coadministration of foscarnet with goserelin due to the risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Both QT prolongation and torsade de pointes (TdP) have been reported during postmarketing use of foscarnet.
Fostemsavir: (Moderate) Consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients receiving other QT prolonging agents. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Supratherapeutic doses of fostemsavir (2,400 mg twice daily, 4 times the recommended daily dose) have been shown to cause QT prolongation. Fostemsavir causes dose-dependent QT prolongation.
Gemifloxacin: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving gemifloxacin as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Gemifloxacin may prolong the QT interval in some patients. The maximal change in the QTc interval occurs approximately 5 to 10 hours following oral administration of gemifloxacin. The likelihood of QTc prolongation may increase with increasing dose of the drug; therefore, the recommended dose should not be exceeded especially in patients with renal or hepatic impairment where the Cmax and AUC are slightly higher. Androgen deprivation therapy may also prolong the QT/QTc interval.
Gemtuzumab Ozogamicin: (Moderate) Obtain an ECG and serum electrolytes prior to initiation of concomitant use of gemtuzumab ozogamicin and goserelin due to the potential for additive QT prolongation and the risk of torsade de pointes (TdP); monitor ECGs and electrolytes as needed during treatment. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Although QT interval prolongation has not been reported with gemtuzumab, it has been reported with other drugs that contain calicheamicin.
Gilteritinib: (Moderate) Use caution and monitor for additive QT prolongation if concurrent use of gilteritinib and goserelin is necessary. Consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients receiving other QT prolonging agents. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Gilteritinib has also been associated with QT prolongation.
Glasdegib: (Major) Avoid coadministration of glasdegib with goserelin due to the potential for additive QT prolongation. If coadministration cannot be avoided, monitor patients for increased risk of QT prolongation with increased frequency of ECG monitoring. Glasdegib therapy may result in QT prolongation and ventricular arrhythmias including ventricular fibrillation and ventricular tachycardia. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Granisetron: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving granisetron as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. Granisetron has also been associated with QT prolongation.
Halogenated Anesthetics: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving halogenated anesthetics. Androgen deprivation therapy may prolong the QT/QTc interval. Halogenated anesthetics can also prolong the QT interval.
Haloperidol: (Major) Avoid coadministration of goserelin with haloperidol due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Haloperidol can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Additionally, QT prolongation and torsade de pointes (TdP) have been observed during haloperidol treatment; excessive doses (particularly in the overdose setting) or IV administration may be associated with a higher risk. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Hydrochlorothiazide, HCTZ; Methyldopa: (Major) Avoid coadministration of goserelin with methyldopa due to the risk of reduced efficacy of goserelin. Methyldopa can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Hydroxychloroquine: (Major) Concomitant use of hydroxychloroquine and goserelin acetate increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Hydroxyzine: (Moderate) Concomitant use of hydroxyzine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Ibutilide: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving ibutilide. Ibutilide administration can cause QT prolongation and torsade de pointes (TdP); proarrhythmic events should be anticipated. The potential for proarrhythmic events with ibutilide increases with the coadministration of other drugs that prolong the QT interval. Androgen deprivation therapy may also prolong the QT/QTc interval.
Iloperidone: (Major) Avoid coadministration of goserelin with iloperidone due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Iloperidone can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Iloperidone has been associated with QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Imipramine: (Minor) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving imipramine. Tricyclic antidepressants share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Androgen deprivation therapy may also prolong the QT/QTc interval.
Inotuzumab Ozogamicin: (Major) Avoid coadministration of inotuzumab with goserelin due to the potential for additive QT prolongation and torsade de pointes (TdP). If coadministration is unavoidable, obtain ECGs prior to the start of treatment and periodically during treatment. Inotuzumab has been associated with QT interval prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Itraconazole: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving itraconazole as concurrent use may increase the risk of QT prolongation. Itraconazole has been associated with prolongation of the QT interval. Androgen deprivation therapy may also prolong the QT/QTc interval.
Ivosidenib: (Major) Avoid coadministration of ivosidenib with goserelin if possible due to an increased risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs for QTc prolongation and monitor electrolytes; correct any electrolyte abnormalities as clinically appropriate. An interruption of therapy and dose reduction of ivosidenib may be necessary if QT prolongation occurs. Prolongation of the QTc interval and ventricular arrhythmias have been reported in patients treated with ivosidenib. Androgen deprivation therapy (i.e., goserelin) also may prolong the QT/QTc interval.
Ketoconazole: (Contraindicated) Avoid concomitant use of ketoconazole and androgen deprivation therapy (i.e., goserelin) due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation.
Lansoprazole; Amoxicillin; Clarithromycin: (Major) Avoid coadministration of clarithromycin with goserelin. Clarithromycin is associated with an established risk for QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Lapatinib: (Moderate) Consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients receiving lapatinib as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval. Lapatinib has been associated with concentration-dependent QT prolongation; ventricular arrhythmias and torsade de pointes (TdP) have been reported in postmarketing experience with lapatinib.
Lefamulin: (Major) Avoid coadministration of lefamulin with goserelin as concurrent use may increase the risk of QT prolongation. If coadministration cannot be avoided, monitor ECG during treatment. Lefamulin has a concentration dependent QTc prolongation effect. The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between lefamulin and other drugs that effect cardiac conduction is unknown. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Lenvatinib: (Major) Avoid coadministration of lenvatinib with goserelin due to the risk of QT prolongation. Prolongation of the QT interval has been reported with lenvatinib therapy. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Levofloxacin: (Moderate) Concomitant use of levofloxacin and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Levoketoconazole: (Contraindicated) Avoid concomitant use of ketoconazole and androgen deprivation therapy (i.e., goserelin) due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation.
Lithium: (Major) Concomitant use of lithium and goserelin acetate increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Lofexidine: (Moderate) Monitor ECGs for QT prolongation if coadministration of lofexidine with goserelin is necessary. Lofexidine prolongs the QT interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Loperamide: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving loperamide. At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes (TdP), and cardiac arrest. Androgen deprivation therapy may also prolong the QT/QTc interval.
Loperamide; Simethicone: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving loperamide. At high doses, loperamide has been associated with serious cardiac toxicities, including syncope, ventricular tachycardia, QT prolongation, torsade de pointes (TdP), and cardiac arrest. Androgen deprivation therapy may also prolong the QT/QTc interval.
Lopinavir; Ritonavir: (Major) Avoid coadministration of lopinavir with goserelin due to the potential for additive QT prolongation. If use together is necessary, obtain a baseline ECG to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Lopinavir is associated with QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Lorcaserin: (Major) Avoid coadministration of goserelin with lorcaserin due to the risk of reduced efficacy of goserelin. Lorcaserin can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Loxapine: (Major) Avoid coadministration of goserelin with loxapine due to the risk of reduced efficacy of goserelin. Loxapine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Macimorelin: (Major) Avoid concurrent administration of macimorelin with drugs that prolong the QT interval, such as goserelin. Use of these drugs together may increase the risk of developing torsade de pointes-type ventricular tachycardia. Sufficient washout time of drugs that are known to prolong the QT interval prior to administration of macimorelin is recommended. Treatment with macimorelin has been associated with an increase in the corrected QT (QTc) interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Maprotiline: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving maprotiline. Maprotiline has been reported to prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Cases of long QT syndrome and torsade de pointes (TdP) tachycardia have been described with maprotiline use, but rarely occur when the drug is used alone in normal prescribed doses and in the absence of other known risk factors for QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval. Limited data are available regarding the safety of maprotiline in combination with other QT-prolonging drugs.
Mefloquine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving mefloquine as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. There is evidence that the use of halofantrine after mefloquine causes a significant lengthening of the QTc interval. Mefloquine alone has not been reported to cause QT prolongation.
Methadone: (Major) Coadministration of methadone with goserelin should be undertaken with extreme caution and a careful assessment of the benefits of therapy versus the risks of QT prolongation. Methadone is associated with an increased risk for QT prolongation and torsade de pointes (TdP), especially at higher doses (greater than 200 mg/day but averaging approximately 400 mg/day in adult patients). Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction. Androgen deprivation therapy may prolong the QT/QTc interval.
Methyldopa: (Major) Avoid coadministration of goserelin with methyldopa due to the risk of reduced efficacy of goserelin. Methyldopa can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Methyltestosterone: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Metoclopramide: (Major) Avoid coadministration of goserelin with metoclopramide due to the risk of reduced efficacy of goserelin. Metoclopramide can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Metronidazole: (Moderate) Concomitant use of metronidazole and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Midostaurin: (Major) Consider periodic monitoring of EGCs for QT prolongation if coadministration of goserelin and midostaurin is necessary. Prolongation of the QT interval was reported in patients who received midostaurin in clinical trials. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Mifepristone: (Major) Concomitant use of mifepristone and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Mirtazapine: (Moderate) Concomitant use of mirtazapine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Mobocertinib: (Major) Concomitant use of mobocertinib and androgen deprivation therapy (i.e., goserelin) increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Molindone: (Major) Avoid coadministration of goserelin with molindone due to the risk of reduced efficacy of goserelin. Molindone can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Moxifloxacin: (Major) Avoid coadministration of moxifloxacin with goserelin as concurrent use may increase the risk of QT prolongation and torsade de pointes (TdP). Quinolones have been associated with a risk of QT prolongation. Although extremely rare, TdP has been reported during postmarketing surveillance of moxifloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Nilotinib: (Major) Avoid administration of nilotinib with goserelin due to the risk of QT interval prolongation. Sudden death and QT prolongation have occurred in patients who received nilotinib therapy. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Nortriptyline: (Minor) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving nortriptyline. Tricyclic antidepressants share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Androgen deprivation therapy may also prolong the QT/QTc interval.
Ofloxacin: (Moderate) Concomitant use of ofloxacin and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Olanzapine: (Major) Avoid coadministration of goserelin with olanzapine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Olanzapine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Olanzapine; Fluoxetine: (Major) Avoid coadministration of goserelin with olanzapine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Olanzapine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval. (Moderate) Concomitant use of fluoxetine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Olanzapine; Samidorphan: (Major) Avoid coadministration of goserelin with olanzapine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Olanzapine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Ondansetron: (Major) Concomitant use of ondansetron and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Do not exceed 16 mg of IV ondansetron in a single dose; the degree of QT prolongation associated with ondansetron significantly increases above this dose.
Osilodrostat: (Moderate) Monitor ECGs in patients receiving osilodrostat with goserelin. Osilodrostat is associated with dose-dependent QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Osimertinib: (Major) Avoid coadministration of goserelin with osimertinib if possible due to the risk of QT prolongation and torsade de pointes (TdP). If concomitant use is unavoidable, periodically monitor ECGs for QT prolongation and monitor electrolytes; an interruption of osimertinib therapy with dose reduction or discontinuation may be necessary if QT prolongation occurs. Concentration-dependent QTc prolongation occurred during clinical trials of osimertinib. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Oxaliplatin: (Major) Monitor ECGs for QT prolongation and monitor electrolytes in patients receiving oxaliplatin concomitantly with goserelin; correct electrolyte abnormalities prior to administration of oxaliplatin. Prolongation of the QT interval and ventricular arrhythmias including fatal torsade de pointes (TdP) have been reported with oxaliplatin use in postmarketing experience. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Oxandrolone: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Oxymetholone: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Ozanimod: (Major) In general, do not initiate ozanimod in patients taking goserelin due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). If treatment initiation is considered, seek advice from a cardiologist. Ozanimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays. Ozanimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Pacritinib: (Major) Concomitant use of pacritinib and androgen deprivation therapy (i.e., goserelin) increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Paliperidone: (Major) Avoid coadministration of goserelin with paliperidone due to the risk of reduced efficacy of goserelin and the risk of QT prolongation. Paliperidone can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Paliperidone has been associated with QT prolongation; torsade de pointes (TdP) and ventricular fibrillation have been reported in the setting of overdose. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Panobinostat: (Major) Coadministration of panobinostat with goserelin is not recommended due to the risk of QT prolongation. Prolongation of the QT interval has been reported with panobinostat treatment. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Pasireotide: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving pasireotide as concurrent use may increase the risk of QT prolongation. Prolongation of the QT interval has occurred with pasireotide at therapeutic and supra-therapeutic doses. Androgen deprivation therapy may also prolong the QT/QTc interval.
Pazopanib: (Major) Coadministration of pazopanib and goserelin is not advised due to the risk of QT prolongation. If concomitant use is unavoidable, closely monitor ECGs for QT interval prolongation. Pazopanib has been reported to prolong the QT interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Pentamidine: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving pentamidine. Systemic pentamidine has been associated with QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval.
Perphenazine: (Major) Avoid coadministration of goserelin with perphenazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Perphenazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Perphenazine is associated with a possible risk for QT prolongation. Theoretically, perphenazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Perphenazine; Amitriptyline: (Major) Avoid coadministration of goserelin with perphenazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Perphenazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Perphenazine is associated with a possible risk for QT prolongation. Theoretically, perphenazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Pimavanserin: (Major) Avoid coadministration of pimavanserin with goserelin due to additive QT effects and increased risk of cardiac arrhythmia. Pimavanserin prolongs the QT interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Pimozide: (Contraindicated) Because of the potential for torsade de pointes (TdP), use of goserelin with pimozide is contraindicated; the efficacy of goserelin may also be reduced. Pimozide is associated with a well-established risk of QT prolongation and TdP. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval. Pimozide can also cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Pitolisant: (Major) Avoid coadministration of pitolisant with goserelin as concurrent use may increase the risk of QT prolongation. Pitolisant prolongs the QT interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Ponesimod: (Major) In general, do not initiate ponesimod in patients taking goserelin due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). If treatment initiation is considered, seek advice from a cardiologist. Ponesimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays. Ponesimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Posaconazole: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving posaconazole as concurrent use may increase the risk of QT prolongation. Posaconazole has been associated with prolongation of the QT interval as well as rare cases of torsade de pointes (TdP). Androgen deprivation therapy may also prolong the QT/QTc interval.
Prasterone, Dehydroepiandrosterone, DHEA (Dietary Supplements): (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Prasterone, Dehydroepiandrosterone, DHEA (FDA-appro

ved): (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Primaquine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving primaquine as concurrent use may increase the risk of QT prolongation. Primaquine has the potential to cause QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval.
Procainamide: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving procainamide. Procainamide is associated with a well-established risk of QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy may also prolong the QT/QTc interval.
Prochlorperazine: (Major) Avoid coadministration of goserelin with prochlorperazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Prochlorperazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Prochlorperazine is associated with a possible risk for QT prolongation. Theoretically, prochlorperazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Promethazine: (Major) Avoid coadministration of goserelin with promethazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Promethazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Promethazine; Dextromethorphan: (Major) Avoid coadministration of goserelin with promethazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Promethazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Promethazine; Phenylephrine: (Major) Avoid coadministration of goserelin with promethazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Promethazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Promethazine, a phenothiazine, is associated with a possible risk for QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Propafenone: (Major) Concomitant use of propafenone and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Protriptyline: (Minor) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving protriptyline. Tricyclic antidepressants share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Androgen deprivation therapy may also prolong the QT/QTc interval.
Quetiapine: (Major) Concomitant use of quetiapine and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Quinidine: (Major) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving quinidine. Quinidine administration is associated with QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy may also prolong the QT/QTc interval.
Quinine: (Major) Avoid coadministration of quinine with goserelin due to the risk of QT prolongation and torsade de pointes (TdP). Quinine has been associated with QT prolongation and rare cases of TdP. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Quizartinib: (Major) Concomitant use of quizartinib and androgen deprivation therapy (i.e., goserelin) increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Ramelteon: (Major) Avoid coadministration of goserelin with ramelteon due to the risk of reduced efficacy of goserelin. Ramelteon can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Ranolazine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving ranolazine as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval. Ranolazine is associated with dose- and plasma concentration-related increases in the QTc interval. Although there are no studies examining the effects of ranolazine in patients receiving other QT prolonging drugs, coadministration of such drugs may result in additive QT prolongation.
Ribociclib: (Major) Avoid coadministration of ribociclib with goserelin due to the risk of QT prolongation. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. Ribociclib-related ECG changes typically occurred within the first four weeks of treatment and were reversible with dose interruption. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Ribociclib; Letrozole: (Major) Avoid coadministration of ribociclib with goserelin due to the risk of QT prolongation. Ribociclib has been shown to prolong the QT interval in a concentration-dependent manner. Ribociclib-related ECG changes typically occurred within the first four weeks of treatment and were reversible with dose interruption. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Rilpivirine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving rilpivirine as concurrent use may increase the risk of QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval.
Risperidone: (Major) Avoid coadministration of goserelin with risperidone due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Risperidone can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Risperidone has been associated with a possible risk for QT prolongation and/or TdP, primarily in the overdose setting. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Romidepsin: (Moderate) Monitor ECGs for QT prolongation and monitor electrolytes at baseline and periodically during treatment if coadministration of romidepsin with goserelin is necessary. Romidepsin has been reported to prolong the QT interval. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Saquinavir: (Major) Avoid coadministration of saquinavir with goserelin if possible due to the risk of QT prolongation. If concomitant use is unavoidable, perform a baseline QCT prior to initiation of therapy and carefully follow monitoring recommendations. Saquinavir boosted with ritonavir increases the QT interval in a dose-dependent fashion, which may increase the risk for serious arrhythmias such as torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Selpercatinib: (Major) Monitor ECGs more frequently for QT prolongation if coadministration of selpercatinib with goserelin is necessary due to the risk of additive QT prolongation. Concentration-dependent QT prolongation has been observed with selpercatinib therapy. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Sertraline: (Moderate) Concomitant use of sertraline and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP. The degree of QT prolongation associated with sertraline is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 2 times the maximum recommended dose.
Siponimod: (Major) In general, do not initiate treatment with siponimod in patients receiving goserelin due to the potential for QT prolongation. Consult a cardiologist regarding appropriate monitoring if siponimod use is required. Siponimod therapy prolonged the QT interval at recommended doses in a clinical study. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Sodium Stibogluconate: (Moderate) Concomitant use of sodium stibogluconate and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Solifenacin: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving solifenacin. Solifenacin has been associated with dose-dependent prolongation of the QT interval; torsade de pointes (TdP) has been reported with postmarketing use, although causality was not determined. Androgen deprivation therapy may also prolong the QT/QTc interval.
Sorafenib: (Major) Avoid coadministration of sorafenib with goserelin due to the risk of additive QT prolongation. If concomitant use is unavoidable, monitor electrocardiograms and correct electrolyte abnormalities. An interruption or discontinuation of sorafenib therapy may be necessary if QT prolongation occurs. Sorafenib is associated with QTc prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Sotalol: (Major) Concomitant use of sotalol and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Sunitinib: (Moderate) Monitor for evidence of QT prolongation if sunitinib is administered with goserelin. Sunitinib can prolong the QT interval. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Tacrolimus: (Moderate) Consider ECG and electrolyte monitoring periodically during treatment if tacrolimus is administered with goserelin. Tacrolimus may prolong the QT interval and cause torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Tamoxifen: (Moderate) Concomitant use of tamoxifen and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Telavancin: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving telavancin as concurrent use may increase the risk of QT prolongation. Androgen deprivation therapy may prolong the QT/QTc interval and telavancin has also been associated with QT prolongation.
Testosterone: (Major) Avoid concurrent use of androgens with gonadotropin releasing hormone (GnRH) agonists such as goserelin. Goserelin inhibits steroidogenesis; concomitant use with androgens may counteract this therapeutic effect.
Tetrabenazine: (Major) Avoid coadministration of goserelin with tetrabenazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Tetrabenazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Tetrabenazine also causes a small increase in the corrected QT interval (QTc). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Thioridazine: (Contraindicated) Because of the potential for torsade de pointes (TdP), use of goserelin with thioridazine is contraindicated; the efficacy of goserelin may also be reduced. Thioridazine is associated with a well-established risk of QT prolongation and TdP. Thioridazine is considered contraindicated for use along with agents that may prolong the QT interval and increase the risk of TdP, and/or cause orthostatic hypotension. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval. Thioridazine can also cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Thiothixene: (Major) Avoid coadministration of goserelin with thiothixene due to the risk of reduced efficacy of goserelin. Thiothixene can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Tolterodine: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving tolterodine. Tolterodine has been associated with dose-dependent prolongation of the QT interval, especially in poor CYP2D6 metabolizers. Androgen deprivation therapy may also prolong the QT/QTc interval.
Toremifene: (Major) Avoid coadministration of goserelin with toremifene due to the risk of additive QT prolongation. If concomitant use is unavoidable, closely monitor ECGs for QT prolongation and monitor electrolytes. Toremifene has been shown to prolong the QTc interval in a dose- and concentration-related manner. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Trandolapril; Verapamil: (Major) Avoid coadministration of goserelin with verapamil due to the risk of reduced efficacy of goserelin. Verapamil can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Trazodone: (Major) Concomitant use of trazodone and goserelin increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Triclabendazole: (Moderate) Concomitant use of triclabendazole and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Trifluoperazine: (Major) Avoid coadministration of goserelin with trifluoperazine due to the risk of reduced efficacy of goserelin; QT prolongation may also occur. Trifluoperazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog. Trifluoperazine is also associated with a possible risk for QT prolongation. Theoretically, trifluoperazine may increase the risk of QT prolongation if coadministered with other drugs that have a risk of QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Trimipramine: (Minor) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving trimipramine. Tricyclic antidepressants share pharmacologic properties similar to the Class IA antiarrhythmic agents and may prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Androgen deprivation therapy may also prolong the QT/QTc interval.
Valbenazine: (Major) Avoid coadministration of goserelin with valbenazine due to the risk of reduced efficacy of goserelin. Valbenazine can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Vandetanib: (Major) Avoid coadministration of vandetanib with goserelin due to an increased risk of QT prolongation and torsade de pointes (TdP). If concomitant use is unavoidable, monitor ECGs for QT prolongation and monitor electrolytes; correct hypocalcemia, hypomagnesemia, and/or hypomagnesemia prior to vandetanib administration. An interruption of vandetanib therapy or dose reduction may be necessary for QT prolongation. Vandetanib can prolong the QT interval in a concentration-dependent manner; TdP and sudden death have been reported in patients receiving vandetanib. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Vardenafil: (Moderate) Concomitant use of vardenafil and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Vemurafenib: (Major) Closely monitor ECGs for QT prolongation if coadministration of vemurafenib with goserelin is necessary. Vemurafenib has been associated with QT prolongation. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Venlafaxine: (Moderate) Concomitant use of venlafaxine and androgen deprivation therapy (i.e., goserelin) may increase the risk of QT/QTc prolongation and torsade de pointes (TdP) in some patients. Consider taking steps to minimize the risk of QT/QTc interval prolongation and TdP, such as avoidance, electrolyte monitoring and repletion, and ECG monitoring, especially in patients with additional risk factors for TdP.
Verapamil: (Major) Avoid coadministration of goserelin with verapamil due to the risk of reduced efficacy of goserelin. Verapamil can cause hyperprolactinemia, which reduces the number of pituitary gonadotropin releasing hormone (GnRH) receptors; goserelin is a GnRH analog.
Voclosporin: (Moderate) Concomitant use of voclosporin and goserelin may increase the risk of QT prolongation. Consider interventions to minimize the risk of progression to torsades de pointes (TdP), such as ECG monitoring and correcting electrolyte abnormalities, particularly in patients with additional risk factors for TdP. Voclosporin has been associated with QT prolongation at supratherapeutic doses. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.
Vonoprazan; Amoxicillin; Clarithromycin: (Major) Avoid coadministration of clarithromycin with goserelin. Clarithromycin is associated with an established risk for QT prolongation and torsade de pointes (TdP). Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Voriconazole: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving voriconazole as concurrent use may increase the risk of QT prolongation. Voriconazole has been associated with QT prolongation and rare cases of torsade de pointes. Androgen deprivation therapy may also prolong the QT/QTc interval.
Vorinostat: (Moderate) Consider whether the benefits of androgen deprivation therapy (i.e., goserelin) outweigh the potential risks of QT prolongation in patients receiving vorinostat. Vorinostat therapy is associated with a risk of QT prolongation. Androgen deprivation therapy may also prolong the QT/QTc interval.
Ziprasidone: (Major) Concomitant use of ziprasidone and goserelin should be avoided due to a potential for additive QT prolongation. Clinical trial data indicate that ziprasidone causes QT prolongation; there are postmarketing reports of torsade de pointes (TdP) in patients with multiple confounding factors. Androgen deprivation therapy (i.e., goserelin) may prolong the QT/QTc interval.

Goserelin/Goserelin Acetate/Zoladex Subcutaneous Imp: 3.6mg, 10.8mg

Adults

Males: 3.6 mg subcutaneously depot every 28 days or one 10.8 mg depot subcutaneously every 3 months.
Females: 3.6 mg subcutaneously depot every 28 days.

Geriatric

Males: 3.6 mg subcutaneously depot every 28 days or one 10.8 mg depot subcutaneously every 3 months.
Females: 3.6 mg subcutaneously depot every 28 days.

Adolescents

Safety and effectiveness have not been established.

Children

Safety and effectiveness have not been established.

Goserelin, a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH), is a GnRH agonist. It inhibits pituitary gonadotropin secretion when administered in the biodegradable formulation. In animal and in vitro studies, administration of goserelin resulted in the regression or inhibition of growth of the hormonally sensitive dimethylbenzanthracene (DMBA)-induced rat mammary tumor and Dunning R3327 prostate tumor.
 
In males, goserelin causes an initial increase in serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels, with subsequent increases in serum levels of testosterone. Over time, chronic administration of goserelin leads to sustained suppression of pituitary gonadotropins causing serum testosterone levels to fall to castration levels approximately 2 to 4 weeks after initiation of therapy; this leads to accessory sex organ regression. In clinical trials with follow-up of more than 2 years, suppression of serum testosterone to castrate levels has been maintained for the duration of therapy.
 
In females, a similar down-regulation of the pituitary gland occurs with chronic exposure to goserelin leading to suppression of gonadotropin secretion, a decrease in serum estradiol to levels consistent with the postmenopausal state, and would be expected to lead to a reduction of ovarian size and function, reduction in the size of the uterus and mammary gland, as well as a regression of sex hormone-responsive tumors, if present. Serum estradiol is suppressed to levels similar to those observed in postmenopausal women within 3 weeks after the initial dose; however, after suppression was attained, isolated elevations of estradiol were seen in 10% of patients. Serum LH and FSH are suppressed to follicular phase levels within 4 weeks after the first dose of goserelin and typically remain at that range with continued treatment. Serum LH and FSH levels are not suppressed to follicular phase levels on day 28 after a single 3.6 mg depot injection in 5% of women or less. Estradiol, LH, and FSH levels return to pretreatment values within 12 weeks after the last implant is placed.

Goserelin is administered subcutaneously. It was 27.3% bound to plasma proteins in one sample from both healthy volunteers and patients (both male and female). The apparent volume of distribution after subcutaneous administration of 250 mcg of goserelin aqueous solution was 44.1 (+/- 13.6) liters for males and 20.3 liters for females. Goserelin is metabolized by hydrolysis of the C-terminal amino acids. The major circulating component in serum appears to be 1-7 fragment, and the major component in the urine of one healthy male volunteer was 5-10 fragment. Goserelin clearance is rapid and was significantly greater in males (110.5 +/- 47.5 mL/min) versus females (163.9 +/- 71 mL/min) when administered as a 3.6 mg depot injection; the mean systemic clearance of goserelin in men after administration of a 10.8 mg depot injection was 121 +/- 42.4 mL/min. More than 90% of a subcutaneous radiolabeled dose of goserelin solution is excreted in the urine, with approximately 20% as unchanged drug.
 
Affected cytochrome P450 isoenzymes and drug transporters: None

Subcutaneous Route

Goserelin is rapidly absorbed, with peak blood concentrations of radiolabeled drug reached between 0.5 to 1 hour after dosing. After administration of the 3.6 mg depot for 2 months, the Cmax in males was 2.84 +/- 1.81 ng/mL in males and 1.46 +/- 0.82 ng/mL in females; the time to peak concentration (Tmax) was 12 to 15 days in males and 8 to 22 days in females. The AUC of goserelin for the 28-day dosing period was 27.8 +/- 15.3 ng x day/mL in males and 18.5 +/- 10.3 ng x day/mL in females. Goserelin is released from the depot at a much slower rate for the first 8 days, and then there is more rapid and continuous release for the remainder for the 28-day dosing period of the 3.6 mg depot; despite this, the every-28-day administration schedule results in testosterone levels that were maintained in the range normally seen in surgically castrated men.
 
After administration of goserelin 10.8 mg depot to men with prostate cancer, the initial release of goserelin reached a peak concentration of 1.8 +/- 0.34 hours after dosing. The Cmax was 8.85 +/- 2.83 ng/mL and the Cmin was 0.37 +/- 0.21 ng/mL. From day 4 until the end of the 12-week dosing period, the sustained release of goserelin from the depot produced reasonable stable systemic exposure; there was no clinically significant accumulation of goserelin following administration of four depots administered at 12-week intervals. Administration of goserelin 10.8 mg every 12 weeks suppressed testosterone to castration levels in approximately 91% of patients.

Pregnancy

Due to the potential for serious adverse reactions in nursing infants from goserelin, advise women to discontinue breast-feeding during treatment. It is not known whether goserelin is present in human milk, although many drugs are excreted in human milk.