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FOLLISTIM AQ- follitropin injection, solution Organon USA Inc.
Follistim AQ is a gonadotropin indicated:
In Women for:
In Men for:
Ovulation Induction in Women (2.2)
Assisted Reproductive Technology (ART) in Women (2.3)
Induction of Spermatogenesis in Men (2.4)
Single-Use Vial 75 international units per 0.5 mL (3)
Single-Use Vial 150 international units per 0.5 mL (3)
Women and men who exhibit:
Women who exhibit:
Treatment with Follistim AQ may result in:
The most common adverse reactions (≥2%) in women undergoing ovulation induction are: ovarian hyperstimulation syndrome, ovarian cyst, abdominal discomfort, abdominal pain and lower abdominal pain. (6.1)
The most common adverse reactions (≥2%) in women receiving ART are ovarian hyperstimulation syndrome and abdominal pain. (6.1)
The most common (≥2%) adverse reactions in men undergoing induction of spermatogenesis are headache, acne, injection site reaction, injection site pain, gynecomastia, rash and dermoid cyst. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Nursing Mothers: It is not known whether this drug is excreted in human milk. (8.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Follistim® AQ (follitropin beta injection) is indicated:
In Women for:
Prior to initiation of treatment with Follistim AQ:
In Men for:
The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].
The following should be considered when planning the woman's individualized dose:
It is recommended that Follistim AQ administration be stopped if the ovarian monitoring suggests an increased risk of OHSS or abdominal pain occurs. Most OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days post-ovulation.
The dosing scheme follows a stepwise approach and is individualized for each woman.
The concomitant therapy should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. If a man has not responded after this period, the combination therapy may be continued. Treatment response has been noted at up to 12 months.
Follistim AQ Single-Use Vial 75 international units per 0.5 mL
Follistim AQ Single-Use Vial 150 international units per 0.5 mL
Follistim AQ is contraindicated in women and men who exhibit:
Follistim AQ is also contraindicated in women who exhibit:
Follistim AQ should be used only by physicians who are experienced in infertility treatment. Follistim AQ is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) [see Warnings and Precautions (5.2)] with or without pulmonary or vascular complications [see Warnings and Precautions (5.3)] and multiple births [see Warnings and Precautions (5.5)]. Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.10)].
Careful attention should be given to the diagnosis of infertility and in the selection of candidates for Follistim AQ therapy [see Indications and Usage (1.1, 1.2, 1.3) and Dosage and Administration (2.2, 2.3, 2.4)].
In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with Follistim AQ therapy, treatment should be individualized and the lowest effective dose should be used [see Dosage and Administration (2.2, 2.3)]. Use of ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels is important to minimize the risk of overstimulation [see Warnings and Precautions (5.8)].
If the ovaries are abnormally enlarged on the last day of Follistim AQ therapy, hCG should not be administered in order to reduce the chances of developing Ovarian Hyperstimulation Syndrome (OHSS). Intercourse should be prohibited in patients with significant ovarian enlargement after ovulation because of the danger of hemoperitoneum resulting from ruptured ovarian cysts [see Warnings and Precautions (5.3)].
OHSS is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical condition. OHSS is characterized by a dramatic increase in vascular permeability, which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of OHSS developing are severe pelvic pain, nausea, vomiting, and weight gain. Abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria have been reported with OHSS. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic reactions [see Warnings and Precautions (5.3)]. Transient liver function test abnormalities suggestive of hepatic dysfunction with or without morphologic changes on liver biopsy have also been reported in association with OHSS.
OHSS occurs after gonadotropin treatment has been discontinued and it can develop rapidly, reaching its maximum about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration [see Warnings and Precautions (5.1)], the hCG must be withheld. Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least two weeks after hCG administration.
If serious OHSS occurs, treatment should be stopped and the patient should be hospitalized. Treatment is primarily symptomatic and overall should consist of bed rest, fluid and electrolyte management, and analgesics (if needed). Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below. The management of OHSS may be divided into three phases as follows:
OHSS increases the risk of injury to the ovary. The ascitic, pleural, and pericardial fluid should not be removed unless there is the necessity to relieve symptoms such as pulmonary distress or cardiac tamponade. Pelvic examination may cause rupture of an ovarian cyst, which may result in hemoperitoneum, and should therefore be avoided. If bleeding occurs and requires surgical intervention, the clinical objective should be to control the bleeding and retain as much ovarian tissue as possible.
During clinical trials with Follistim therapy, OHSS occurred in 7.6% of 105 women (OI) and 5.2% of 591 women (ART) treated with Follistim.
Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome) have been reported in women treated with gonadotropins. In addition, thromboembolic reactions both in association with, and separate from, OHSS have been reported following gonadotropin therapy. Intravascular thrombosis, which may originate in venous or arterial vessels, can result in reduced blood flow to vital organs or the extremities. Women with generally recognized risk factors for thrombosis, such as a personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events, during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb and rarely in myocardial infarction. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death. In women with recognized risk factors, the benefits of ovulation induction or in vitro fertilization (IVF) treatment need to be weighed against the risks. It should be noted that pregnancy itself also carries an increased risk of thrombosis.
Ovarian torsion has been reported after treatment with Follistim AQ and after intervention with other gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multi-fetal gestation and births have been reported with all gonadotropin treatments including Follistim AQ treatment. The woman and her partner should be advised of the potential risk of multi-fetal gestation and births before starting treatment.
The incidence of congenital malformations after ART may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, sperm characteristics) and to the higher incidence of multi-fetal gestations after ART. There are no indications that the use of gonadotropins during ART is associated with an increased risk of congenital malformations.
Since infertile women undergoing ART, and particularly IVF, often have tubal abnormalities the incidence of ectopic pregnancies might be increased. Early confirmation of an intrauterine pregnancy should be determined by hCG testing and transvaginal ultrasound.
The risk of spontaneous abortions (miscarriage) is increased with gonadotropin products. However, causality has not been established. The increased risk may be a factor of the underlying infertility.
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.
In most instances, treatment with Follistim AQ will result only in follicular growth and maturation. In order to complete the final phase of follicular maturation and to induce ovulation, hCG must be given following the administration of Follistim AQ or when clinical assessment indicates that sufficient follicular maturation has occurred. The degree of follicular maturation and the timing of hCG administration can both be determined with the use of sonographic visualization of the ovaries and endometrial lining in conjunction with measurement of serum estradiol levels. The combination of transvaginal ultrasonography and measurement of serum estradiol levels is also useful for minimizing the risk of OHSS and multi-fetal gestations.
The clinical confirmation of ovulation is obtained by the following direct or indirect indices of progesterone production as well as sonographic evidence of ovulation.
Direct or indirect indices of progesterone production are:
The following provide sonographic evidence of ovulation:
Sonographic evaluation of the early pregnancy is also important to rule out ectopic pregnancy.
Clinical monitoring for spermatogenesis utilizes the following indirect or direct measures:
The following serious adverse reactions are discussed elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a single cycle, multi-center, assessor-blind, parallel group, comparative study, a total of 172 chronic anovulatory women who had failed to ovulate and/or conceive with clomiphene citrate therapy, were randomized and treated with Follistim (105) or a urofollitropin comparator. Adverse reactions with an incidence of greater than 2% in either treatment group are listed in Table 1.
Adverse reactions reported commonly (greater than or equal to 2% of women treated with Follistim) in other ovulation induction clinical trials were headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage and injection site reaction.
The following medical events have been reported subsequent to pregnancies resulting from Follistim AQ therapy:
In a multiple cycle, multi-center, assessor-blind, parallel group, comparative study, after pituitary suppression with a gonadotropin release hormone (GnRH) agonist, a total of 989 women were randomized and treated with Follistim (N=591) or a urofollitropin comparator as part of in vitro fertilization therapy (IVF). Adverse reactions with an incidence of greater than 2% in either treatment group are listed in Table 2.
Adverse reactions reported commonly (greater than or equal to 2% of women treated with Follistim) in other IVF clinical trials were headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, breast tenderness, metrorrhagia, ovarian enlargement, vaginal hemorrhage, injection site reaction and rash.
The following medical events have been reported subsequent to pregnancies resulting from Follistim AQ therapy:
Induction of Spermatogenesis
In an open-label, non-comparative clinical trial, 49 men with hypogonadotropic hypogonadism were enrolled to received pretreatment with hCG, followed by combination therapy with hCG and Follistim for induction of spermatogenesis. Of the 49 men, 30 received weekly Follistim doses of 450 international units; 24 of these 30 men received a total of 48 weeks of treatment with Follistim. Adverse reactions occurring with an incidence of greater than 2% in the 30 men treated with Follistim are listed in Table 3.
The following adverse reactions have been identified during post approval use of Follistim and/or Follistim AQ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Thromboembolism [see Warnings and Precautions (5.3)]
No drug-drug interaction studies have been performed.
Pregnancy Category X: Follistim AQ should not be used during pregnancy [see Contraindications (4)].
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Follistim AQ, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Follistim did not include subjects aged 65 and over.
Aside from the possibility of Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2, 5.3)] and multiple gestations [see Warnings and Precautions (5.5)], there is no additional information concerning the consequences of acute overdosage with Follistim AQ.
Follistim AQ contains human follicle-stimulating hormone (hFSH), a glycoprotein hormone which is manufactured by recombinant DNA (rDNA) technology. The active drug substance, follitropin beta, has a dimeric structure containing two glycoprotein subunits (alpha and beta). Both the 92 amino acid alpha-chain and the 111 amino acid beta-chain have complex heterogeneous structures arising from two N-linked oligosaccharide chains. Follitropin beta is synthesized in a Chinese hamster ovary (CHO) cell line that has been transfected with a plasmid containing the two subunit DNA sequences encoding for hFSH. The purification process results in a highly purified preparation with a consistent hFSH isoform profile and high specific activity [as determined by the Ph. Eur. test for FSH in vivo bioactivity and on the basis of the molar extinction coefficient at 277 nm (εs:mg-1cm-1)=1.066].
The biological activity is determined by measuring the increase in ovary weight in female rats. The intrinsic luteinizing hormone (LH) activity in follitropin beta is less than 1 international unit per 40,000 international units FSH. The compound is considered to contain no LH activity.
The amino acid sequence and tertiary structure of the product are indistinguishable from that of hFSH of urinary source. Also, based on available data derived from physico-chemical tests and bioassay, follitropin beta and follitropin alfa, another recombinant follicle-stimulating hormone product, are indistinguishable.
Follistim AQ is presented as a sterile aqueous solution intended for subcutaneous (in men and women) or intramuscular (women only) administration. Each single-use vial of Follistim AQ contains the following per 0.5 mL: 75 international units or 150 international units of FSH activity; 25 mg sucrose NF; 7.35 mg sodium citrate (dihydrate) USP; 0.25 mg L-methionine USP; 0.1 mg polysorbate 20 NF; and water for injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7.
The recombinant protein in Follistim AQ has been standardized for FSH in vivo bioactivity in terms of the WHO International Standard for Follicle Stimulating Hormone (FSH) Recombinant, Human for Bioassay (code 92/642), issued by the World Health Organization Expert Committee on Biological Standardization (1995). Under current storage conditions, Follistim AQ may contain up to 11% of oxidized follitropin beta.
In clinical trials with Follistim, serum antibodies to FSH or anti-CHO cell derived proteins were not detected in any of the treated patients after exposure to Follistim for up to three cycles.
Therapeutic Class: Infertility.
Follicle-stimulating hormone (FSH), the active component in Follistim AQ, is required for normal follicular growth, maturation, and gonadal steroid production.
In women, the level of FSH is critical for the onset and duration of follicular development, and consequently for the timing and number of follicles reaching maturity. Follistim AQ stimulates ovarian follicular growth in women who do not have primary ovarian failure. In order to effect the final phase of follicle maturation, resumption of meiosis and rupture of the follicle in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following treatment with Follistim AQ when patient monitoring indicates appropriate follicular development parameters have been reached.
Follistim when administered with hCG stimulates spermatogenesis in men with hypogonadotropic hypogonadism. FSH, the active component of Follistim, is the pituitary hormone responsible for spermatogenesis.
Exposures of follitropin beta from Follistim AQ and Follistim are expected to be equivalent. The following information is based on studies conducted with Follistim.
The bioavailability of Follistim following subcutaneous and intramuscular administration was investigated in healthy, pituitary-suppressed, women given a single 300 international units dose. In these women, the area under the curve (AUC), expressed as the mean ± SD, was equivalent between the subcutaneous (455.6 ± 141.4 IU*h/L) and intramuscular (445.7 ± 135.7 IU*h/L) routes of administration. However, equivalence could not be established with respect to the peak serum FSH levels (Cmax). The Cmax achieved after subcutaneous administration and intramuscular administration was 5.41 ± 0.72 international units/L and 6.86 ± 2.90 international units/L, respectively. After subcutaneous or intramuscular injection the apparent dose absorbed was 77.8% and 76.4%, respectively.
The pharmacokinetics and pharmacodynamics of a single, intramuscular dose (300 international units) of Follistim were also investigated in a group (n=8) of gonadotropin-deficient, but otherwise healthy women. In these women, FSH (mean ± SD) AUC was 339 ± 105 international units*h/L, Cmax was 4.3 ± 1.7 international units/L. Cmax occurred at approximately 27 ± 5.4 hours after intramuscular administration.
A multiple dose, dose proportionality, pharmacokinetic study of Follistim was completed in healthy, pituitary-suppressed, women given subcutaneous doses of 75, 150, or 225 international units for 7 days. Steady-state blood concentrations of FSH were reached with all doses after 5 days of treatment based on the trough concentrations of FSH just prior to dosing (Ctrough). Peak blood concentrations with the 75, 150, and 225 international units dose were 4.30 ± 0.60 international units/L, 8.51 ± 1.16 international units/L and 13.92 ± 1.81 international units/L, respectively.
A multiple dose, dose proportionality, pharmacokinetic study of Follistim was completed in healthy, pituitary-suppressed, women given intramuscular doses of 75, 150, or 225 international units for 7 days. Steady-state blood concentrations of FSH were reached with all doses after 4 days of treatment based on the minimum concentrations of FSH just prior to dosing (Cmin). Peak blood concentrations with the 75, 150, and 225 international units dose were 4.65 ± 1.49 international units/L, 9.46 ± 2.57 international units/L and 11.30 ± 1.77 international units/L, respectively.
Serum levels of FSH were measured in a clinical study that compared the effects of two different dosing schedules of Follistim (150 international units three times a week or 225 international units twice a week) administered by subcutaneous injection concurrently with chorionic gonadotropin for injection for induction of spermatogenesis in hypogonadotropic hypogonadal men. Administration of Follistim was started at Week 17. Mean serum trough concentrations of FSH remained fairly constant over the treatment period. At the end of treatment (Week 64), the mean serum trough concentrations of FSH were 2.09 international units/L in the 150 international units group and 3.22 international units/L in the 225 international units group. Serum trough concentrations of FSH measured prior to the first Follistim injection on the Mondays of active treatment period (Weeks 17 to 64) and one week after the end of treatment period are presented in Figure 1.
FIGURE 1: Mean (SD) Serum Trough Concentrations of FSH in Men Following Subcutaneous Administration of Follistim Using Two Different Dosing Schedules (150 International Units Three Times a Week or 225 International Units Twice a Week)
The volume of distribution of Follistim in healthy, pituitary-suppressed, women following intravenous administration of a 300 international units dose was approximately 8 L.
The recombinant FSH in Follistim AQ is biochemically very similar to urinary FSH and it is therefore anticipated that it is metabolized in the same manner.
The elimination half-life (t1/2) following a single intramuscular dose (300 international units) of Follistim in women was 43.9 ± 14.1 hours (mean ± SD). The elimination half-life following a 7-day intramuscular treatment of women with 75, 150, or 225 international units was 26.9 ± 7.8 hours (mean ± SD), 30.1 ± 6.2 and 28.9 ± 6.5, respectively.
Use in Specific Populations:
Body weight: The effect of body weight on the pharmacokinetics of Follistim was evaluated in a group of European and Japanese women who were significantly different in terms of body weight. The European women had a body weight of (mean ± SD) 67.4 ± 13.5 kg and the Japanese subjects were 46.8 ± 11.6 kg. Following a single intramuscular dose of 300 international units of Follistim, the AUC was significantly smaller in European women (339 ± 105 international units*h/L) than in Japanese women (544 ± 201 international units*h/L). However, clearance per kg of body weight was essentially the same for the respective groups (0.014 and 0.013 L/hr/kg).
Geriatric Use: The pharmacokinetics of Follistim has not been studied in geriatric subjects.
Pediatric Use: The pharmacokinetics of Follistim has not been studied in pediatric subjects.
Renal Impairment: The effect of renal impairment on the pharmacokinetics of Follistim has not been studied.
Hepatic Impairment: The effect of hepatic impairment on the pharmacokinetics of Follistim has not been studied.
Long-term toxicity studies in animals have not been performed with Follistim to evaluate the carcinogenic potential of the drug. Follistim was not mutagenic in the Ames test using S. typhimurium and E. coli tester strains and did not produce chromosomal aberrations in an in vitro assay using human lymphocytes.
The efficacy of Follistim for Ovulation Induction was evaluated in a randomized, assessor-blind, parallel-group comparative, multicenter safety and efficacy study of 172 chronic anovulatory women (105 subjects on Follistim) who had previously failed to ovulate and/or conceive during clomiphene citrate treatment. The study results for ovulation rates are summarized in Table 4 and those for pregnancy rates are summarized in Table 5.
The efficacy of Follistim as part of an Assisted Reproductive Technology (ART) program was established in three studies, two of which are described below.
Follistim was evaluated in a randomized, assessor-blind, parallel-group, comparative, multicenter safety and efficacy study of 981 healthy normal ovulatory infertile women (mean age 32) treated for multiple cycles with in vitro fertilization and controlled ovarian stimulation with Follistim (n=585) or urofollitropin (n=396) after pituitary suppression with a GnRH agonist. The first cycle results with Follistim are summarized in Table 6.
Follistim was also evaluated in a randomized, assessor-blind, parallel-group, comparative, single center safety and efficacy study in 89 infertile healthy normal ovulatory women (mean age 32) treated for one cycle with in vitro fertilization and controlled ovarian stimulation with Follistim (n=54) or menotropins (n=35) without pituitary suppression with a GnRH agonist. The results with Follistim are summarized in Table 7.
The safety and efficacy of Follistim administered by subcutaneous injection concomitantly with chorionic gonadotropin for injection (hCG) has been examined in a multicenter, open-label, non-comparator clinical study for induction of spermatogenesis in hypogonadotropic hypogonadal men. The study compared the effects of two different Follistim dosing schedules on semen parameters and serum levels of follicle stimulating hormone (FSH). The multicenter study involved a 16-week pretreatment phase with hCG at a dosage of 1500 international units twice a week to normalize serum testosterone levels. If serum testosterone levels did not normalize after 8 weeks of hCG treatment, the hCG dose could have been increased to 3000 international units twice a week. This phase was followed by a 48-week treatment phase. Men who were still azoospermic after the pretreatment phase were randomized to receive either 225 international units Follistim together with 1500 international units hCG twice a week or 150 international units Follistim three times a week together with 1500 international units hCG twice weekly. Men who required 3000 international units of hCG twice a week in the pretreatment phase were continued on that dosage during the treatment phase. The mean age of patients in both treatment groups was approximately 30 years (range 18 to 47 years). At baseline, mean left and right testis volumes were 4.61 ± 2.94 mL and 4.57 ± 3.00 mL, respectively, in the group receiving three weekly injections of Follistim. For the group receiving two weekly injections of Follistim, the mean left and right testis volumes were 6.54 ± 2.45 mL and 7.21 ± 2.94 mL, respectively, at baseline. The primary efficacy endpoint was the percentage of patients with a mean sperm density of ≥1 x 106/mL on their last two treatment assessments. The outcomes of treatment in the 30 men enrolled in the treatment phase are summarized in Table 8.
Overall, the median time to reach a sperm concentration of 106 per mL was 165 days (range 25 to 327 days) in patients who demonstrated a sperm concentration of at least 106 per mL. The median time to reach a sperm concentration of at least 106 per mL was 186 days (range 25 to 327 days) for the 150 international units group and 141 days (range 43 to 204 days) for the 225 international units group. No pregnancy data were collected during the trial.
The local tolerance data were comparable between the two treatment groups. The mean percentage of days without pain calculated for all subjects in the treatment period was 91.3% for patients in the 150 international units (three times a week) and 76.0% for patients in the 225 international units (two times a week) Follistim treatment groups. In the 225 international units (twice per week) group, local symptoms judged as severe by the investigator were: itching in 1 patient (7%), pain in 2 patients (13%), bruising in 2 patients (13%), swelling in 2 patients (13%), and redness in 1 patient (7%). In the 150 international units (three times per week) group, 1 event in 1 patient (bruising, 7%) was judged as severe. No patient discontinued treatment due to injection site reaction or injection site pain.
Follistim AQ (follitropin beta injection) is supplied as a sterile aqueous solution in a 2-mL vial to deliver 0.5 mL of the drug in the following concentrations and packaging:
Store refrigerated, 2-8°C (36-46°F) until dispensed. Upon dispensing, the product may be stored by the patient at 2-8°C (36-46°F) until the expiration date, or at or below 25°C (77°F) for 3 months or until expiration date, whichever occurs first. Protect from light, keep container in carton. Do not freeze.
See FDA-Approved Patient Labeling
Prior to beginning therapy with Follistim AQ, inform women and men about the time commitment and monitoring procedures necessary to undergo treatment [see Dosage and Administration (2), Warnings and Precautions (5.10)].
Inform women and men that if they miss or forget to take a dose of Follistim AQ, the next dose should not be doubled and they should call the healthcare provider for further dosing instructions.
Inform women regarding the risks with use of Follistim AQ of Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2)] and associated symptoms including lung and blood vessel problems [see Warnings and Precautions (5.3)] and ovarian torsion [see Warnings and Precautions (5.4)].
Inform women regarding the risk of multi-fetal gestations with the use of Follistim AQ [see Warnings and Precautions (5.5)].
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC., Whitehouse Station, NJ 08889, USA
Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA
For patent information: www.merck.com/product/patent/home.html
Copyright © 2005, 2010 Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc. All rights reserved.
Follistim® (Fol´-lis-tim) AQ(follitropin beta injection)Single-Use Vial
Read the Patient Information that comes with Follistim® AQ before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is Follistim AQ?
Follistim AQ is a prescription medicine that contains follicle-stimulating hormone (FSH).
Follistim AQ is used:
Who should not take Follistim AQ?
Do not take Follistim AQ if you are a Woman or Man who:
Do not take Follistim AQ if you are a Woman who:
Talk to your healthcare provider before taking this medicine if you have any of the conditions listed above.
What should I tell my healthcare provider before taking Follistim AQ?
Before you take Follistim AQ, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them and show your healthcare provider and pharmacist when you get a new medicine.
How should I use Follistim AQ?
What are the possible side effects of Follistim AQ?
Follistim AQ may cause serious side effects.
Serious side effects in women include:
The most common side effects of Follistim AQ include:
These are not all the possible side effects of Follistim AQ. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider immediately if you get worsening or strong abdominal pain. Also, call your healthcare provider immediately if this happens some days after the last injection has been given.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Follistim AQ?
Keep Follistim AQ and all medicines out of the reach of children.
General information about Follistim AQ
Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Do not use Follistim AQ for a condition for which it was not prescribed. Do not give Follistim AQ to other people, even if they have the same condition that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about Follistim AQ. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for more information about Follistim AQ that is written for healthcare professionals.
For more information, go to www.follistim.com or call 1-866-836-5633.
What are the ingredients in Follistim AQ?
Active ingredient: follitropin beta
Inactive ingredients: sucrose, sodium citrate, L-methionine, polysorbate 20, water for injection, hydrochloric acid, and/or sodium hydroxide.
Follistim® (Fol´-lis-tim) AQ (follitropin beta injection)Single-Use Vial
Read the Patient Instructions for Use that comes with Follistim® AQ before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
A. Getting Ready
B. Preparing your Follistim AQ Injection
C. Draw up your Dose
D. Remove the Air
E. Selecting and Preparing the Injection Site
How Do I Throw Away Used Syringes and Needles?
Check with your healthcare provider or pharmacist for instructions about the right way to throw away used syringes and needles. There may be special local or state laws about how to throw away used syringes and needles.