Cancidas

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Cancidas

Classes

Echinocandins Antifungals

Administration
Injectable Administration

Visually inspect prepared infusions for particulate matter and discoloration prior to administration.

Intravenous Administration

Reconstitution
Add 10.8 mL of 0.9% Sodium Chloride Injection, Sterile Water for Injection, Bacteriostatic Water for Injection with methylparaben and propylparaben, or Bacteriostatic Water for Injection with 0.9% benzyl alcohol to the 50-mg vial or 70-mg vial for a resultant concentration of 5 mg/mL or 7 mg/mL, respectively.
Mix gently until the solution is clear.
Caspofungin vials are single use only; discard any unused reconstituted solution.
Storage: Reconstituted caspofungin in the vial may be stored at 25 degrees C or less (77 degrees F or less) for 1 hour prior to dilution.
 
Dilution
Add appropriate dose to 250 mL of 0.9% Sodium Chloride Injection, 0.45% Sodium Chloride Injection, 0.225% Sodium Chloride Injection, or Lactated Ringer's Injection. For fluid restricted patients, may dilute dose to a final concentration not to exceed 0.5 mg/mL.
Do not use any diluents containing dextrose to prepare caspofungin.
Storage: The final diluted infusion may be stored for up to 24 hours at 25 degrees C or less (77 degrees F or less), or for up to 48 hours under refrigeration at 2 to 8 degrees C.
 
Intermittent IV Infusion
Administer as a slow IV infusion over approximately 1 hour. Do not administer as an IV bolus injection.
Do not mix or co-infuse caspofungin with other medications or infuse with dextrose-containing solutions.

Adverse Reactions
Severe

pleural effusion / Delayed / 9.0-9.0
hepatic failure / Delayed / 0-5.0
coagulopathy / Delayed / 0-5.0
bradycardia / Rapid / 0-5.0
atrial fibrillation / Early / 0-5.0
myocardial infarction / Delayed / 0-5.0
arrhythmia exacerbation / Early / 0-5.0
cardiac arrest / Early / 0-5.0
renal failure (unspecified) / Delayed / 0-5.0
seizures / Delayed / 0-5.0
hepatic necrosis / Delayed / Incidence not known
erythema multiforme / Delayed / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known
toxic epidermal necrolysis / Delayed / Incidence not known
exfoliative dermatitis / Delayed / Incidence not known
angioedema / Rapid / Incidence not known
bronchospasm / Rapid / Incidence not known
pulmonary edema / Early / Incidence not known
pancreatitis / Delayed / Incidence not known

Moderate

hypotension / Rapid / 3.0-20.0
phlebitis / Rapid / 0-18.0
elevated hepatic enzymes / Delayed / 4.0-13.0
hyperbilirubinemia / Delayed / 6.0-13.0
peripheral edema / Delayed / 6.0-11.0
anemia / Delayed / 2.0-11.0
sinus tachycardia / Rapid / 4.0-11.0
hypertension / Early / 5.0-10.0
erythema / Early / 4.0-9.0
dyspnea / Early / 0-9.0
hypokalemia / Delayed / 5.0-8.0
hepatomegaly / Delayed / 0-5.0
jaundice / Delayed / 0-5.0
skin ulcer / Delayed / 3.0-5.0
hypoxia / Early / 0-5.0
hypercalcemia / Delayed / 0-5.0
hypomagnesemia / Delayed / 0-5.0
hyperglycemia / Delayed / 0-5.0
thrombocytopenia / Delayed / 0-5.0
neutropenia / Delayed / 0-5.0
constipation / Delayed / 0-5.0
fluid retention / Delayed / 0-5.0
hematuria / Delayed / 0-5.0
confusion / Early / 0-5.0
depression / Delayed / 0-5.0
edema / Delayed / 3.0-4.0
tachypnea / Early / 1.0-1.0
hepatitis / Delayed / Incidence not known

Mild

fever / Early / 6.0-30.0
diarrhea / Early / 6.0-27.0
rash / Early / 4.0-23.0
chills / Rapid / 9.0-23.0
headache / Early / 5.0-15.0
infection / Delayed / 0-14.0
cough / Delayed / 6.0-11.0
abdominal pain / Early / 4.0-9.0
nausea / Early / 9.0-9.0
vomiting / Early / 8.0-8.0
pruritus / Rapid / 6.0-7.0
petechiae / Delayed / 0-5.0
urticaria / Rapid / 0-5.0
flushing / Rapid / 0-5.0
epistaxis / Delayed / 0-5.0
injection site reaction / Rapid / 0-5.0
dyspepsia / Early / 0-5.0
anorexia / Delayed / 0-5.0
asthenia / Delayed / 0-5.0
arthralgia / Delayed / 0-5.0
fatigue / Early / 0-5.0
anxiety / Delayed / 0-5.0
dizziness / Early / 0-5.0
insomnia / Early / 0-5.0
drowsiness / Early / 0-5.0
tremor / Early / 0-5.0
back pain / Delayed / 4.0-4.0

Common Brand Names

Cancidas

Dea Class

Rx

Description

IV echinocandin antifungal
Used for aspergillosis, candidemia, esophageal candidiasis, and empiric treatment in febrile neutropenia
Fever and infusion-related reactions common

Dosage And Indications
For the treatment of candidemia and invasive candidiasis, including chronic disseminated (hepatosplenic) candidiasis†. For the treatment of chronic disseminated (hepatosplenic) candidiasis†. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily for several weeks, followed by oral fluconazole for patients who are unlikely to have a fluconazole-resistant isolate. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants, Children, and Adolescents 3 months to 17 years

70 mg/m2/dose (Max: 70 mg/dose) IV loading dose on day 1, then 50 mg/m2/dose (Max: 70 mg/dose) IV once daily for several weeks, followed by oral fluconazole for patients who are unlikely to have a fluconazole-resistant isolate. May increase dose to 70 mg/m2/day (Max: 70 mg/dose) if there is an inadequate clinical response. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

For the treatment of candidemia and invasive candidiasis. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms for invasive candidiasis without metastatic complications. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants, Children, and Adolescents 3 months to 17 years

70 mg/m2/dose (Max: 70 mg/dose) IV loading dose on day 1, followed by 50 mg/m2/dose (Max: 70 mg/dose) IV once daily. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms for invasive candidiasis without metastatic complications. May increase dose to 70 mg/m2/dose (Max: 70 mg/dose) if there is an inadequate clinical response. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants 1 to 2 months†

Very limited data are available; CNS involvement should be presumed in neonates with candidemia. A dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV once daily. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms for invasive candidiasis without metastatic complications. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent.

Neonates†

Very limited data are available; CNS involvement should be presumed in neonates with candidemia. A dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV once daily. Treat for 2 weeks after documented clearance from the bloodstream and resolution of signs and symptoms for invasive candidiasis without metastatic complications. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent.

For the treatment of invasive aspergillosis in patients who are refractory to or intolerant of other antifungal therapies. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

Infants 3 months and older, Children, and Adolescents

70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

Neonates† and Infants 1 to 2 months†

No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement.

For the treatment of esophageal candidiasis, including fluconazole-refractory disease. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily for 14 to 21 days as an alternative. The FDA-approved dosage is 50 mg IV once daily for 7 to 14 days. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants, Children, and Adolescents 3 months to 17 years

70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily for 14 to 21 days as an alternative. The FDA-approved dosage is 50 mg/m2/dose (Max: 70 mg/dose) IV once daily for 7 to 14 days. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants 1 to 2 months†

Limited data are available. 25 mg/m2/dose IV once daily for 14 to 21 days as an alternative. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

For the treatment of respiratory infections (i.e., pneumonia and pleural space infections). For the treatment of Candida pneumonia and pleural space infections. Intravenous dosage Adults

Growth of Candida sp. from the respiratory tract typically reflects colonization and rarely requires antifungal therapy. In cases where pneumonia is associated with disseminated infection, 70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants 3 months and older, Children, and Adolescents

Growth of Candida sp. from the respiratory tract typically reflects colonization and rarely requires antifungal therapy. In cases where pneumonia is associated with disseminated infection, 70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Neonates† and Infants 1 to 2 months†

Growth of Candida sp. from the respiratory tract typically reflects colonization and rarely requires antifungal therapy. Restrict treatment to pneumonia associated with disseminated infection. Very limited data are available. A dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent.

For the treatment of Aspergillus pneumonia and pleural space infections in patients who are refractory to or intolerant of other antifungal therapies. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. In lung transplant recipients with tracheobronchial aspergillosis (TBA) associated with anastomotic endobronchial ischemia or ischemic reperfusion injury, inhaled amphotericin B deoxycholate is suggested in addition to systemic therapy; treat for at least 3 months or until TBA is resolved, whichever is longer. Surgery alone may be used to treat Aspergillus fungal ball of the paranasal sinus.

Infants 3 months and older, Children, and Adolescents

70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. In lung transplant recipients with tracheobronchial aspergillosis (TBA) associated with anastomotic endobronchial ischemia or ischemic reperfusion injury, inhaled amphotericin B deoxycholate is suggested in addition to systemic therapy; treat for at least 3 months or until TBA is resolved, whichever is longer. Surgery alone may be used to treat Aspergillus fungal ball of the paranasal sinus.

Neonates† and Infants 1 to 2 months†

No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. In lung transplant recipients with tracheobronchial aspergillosis (TBA) associated with anastomotic endobronchial ischemia or ischemic reperfusion injury, inhaled amphotericin B deoxycholate is suggested in addition to systemic therapy; treat for at least 3 months or until TBA is resolved, whichever is longer. Surgery alone may be used to treat Aspergillus fungal ball of the paranasal sinus.

For the treatment of bone and joint infections, including osteomyelitis and infectious arthritis. For the treatment of Candida osteomyelitis† or infectious arthritis†. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for at least 2 weeks followed by fluconazole for 6 to 12 months for osteomyelitis or 4 weeks for infectious arthritis. Recommended as an alternative to fluconazole as initial therapy. Surgical debridement may be helpful in some cases of osteomyelitis and is recommended for all cases of septic arthritis. For infection involving a prosthetic device, device removal in addition to antifungal therapy is recommended.

Infants 3 months and older, Children, and Adolescents

70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Treat for at least 2 weeks followed by fluconazole for 6 to 12 months for osteomyelitis or 4 weeks for infectious arthritis. Recommended as an alternative to fluconazole as initial therapy. Surgical debridement may be helpful in some cases of osteomyelitis and is recommended for all cases of septic arthritis. For infection involving a prosthetic device, device removal in addition to antifungal therapy is recommended.

Neonates and Infants 1 to 2 months

Very limited data are available. A dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent. Treat for at least 2 weeks followed by fluconazole for 6 to 12 months for osteomyelitis or 4 weeks for infectious arthritis. Surgical debridement may be helpful in some cases of osteomyelitis and is recommended for all cases of septic arthritis.

For the treatment of Aspergillus osteomyelitis or infectious arthritis in patients who are refractory to or intolerant of other antifungal therapies. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 8 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Longer courses (greater than 6 months) are frequently necessary.

Infants 3 months and older, Children, and Adolescents

70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 8 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Longer courses (greater than 6 months) are frequently necessary.

Neonates† and Infants 1 to 2 months†

No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 8 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. Longer courses (greater than 6 months) are frequently necessary.

For empirical therapy for presumed fungal infection in patients with febrile neutropenia. Intravenous dosage Adults

70 mg IV loading dose on day 1, followed by 50 mg IV once daily. If 50 mg/day is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/day. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Duration of treatment is based on clinical response. Empirical therapy should be continued until neutropenia resolution. Treatment for at least 14 days and for at least 7 days after neutropenia and symptoms resolve is recommended for patients found to have a fungal infection. Recommended in patients with persistent or recurrent fever after 4 to 7 days of antibiotics and anticipated neutropenia duration more than 7 days. Aspergillosis clinical practice guidelines suggest caspofungin as a first line empiric therapy.

Infants 3 months and older, Children, and Adolescents

70 mg/m2/dose IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Duration of treatment is based on clinical response. Empirical therapy should be continued until neutropenia resolution. Treatment for at least 14 days and for at least 7 days after neutropenia and symptoms resolve is recommended for patients found to have a fungal infection. Recommended in patients with persistent or recurrent fever after 4 to 7 days of antibiotics and anticipated neutropenia duration more than 7 days. Aspergillosis clinical practice guidelines suggest caspofungin as a first line empiric therapy.

For the treatment of asymptomatic candiduria in neutropenic persons. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily for 14 days. Candiduria may be the only microbiological documentation of disseminated candidiasis in neutropenic persons; therefore, candiduria should be treated as disseminated candidiasis in these persons. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants, Children, and Adolescents 3 months to 17 years

70 mg/m2/dose (Max: 70 mg/dose) IV loading dose on day 1, then 50 mg/m2/dose (Max: 70 mg/dose) IV once daily for 14 days. May increase the dose to 70 mg/m2/dose (Max: 70 mg/dose) if there is an inadequate clinical response. Candiduria may be the only microbiological documentation of disseminated candidiasis in neutropenic persons; therefore, candiduria should be treated as disseminated candidiasis in these persons. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

For the treatment of fluconazole-refractory oropharyngeal candidiasis (thrush)†. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily for up to 28 days as an alternative. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants, Children, and Adolescents 3 months to 17 years

50 mg/m2/dose IV (Max: 70 mg/dose) once daily for up to 28 days as an alternative. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants 1 to 2 months

Limited data are available. 25 mg/m2/dose IV once daily for up to 28 days as an alternative. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

For the treatment of cardiovascular system infections, including endocarditis†, suppurative thrombophlebitis†, and infected pacemaker†, implantable cardiac defibrillator (ICD)†, or ventricular assist devices (VAD)†. For the treatment of Candida cardiovascular system infections†. Intravenous dosage Adults

150 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. For endocarditis, treat for at least 6 weeks after valve replacement. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal. When valve replacement or hardware removal is not possible, chronic suppressive therapy with fluconazole is recommended after initial treatment. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia (if present) has cleared.

Infants 3 months and older, Children, and Adolescents

70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Although the FDA-approved maximum dose is 70 mg/day, clinical practice guidelines recommend 150 mg IV once daily for adults with cardiac infections. For endocarditis, treat for at least 6 weeks after valve replacement. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal. When valve replacement or hardware removal is not possible, chronic suppressive therapy with fluconazole is recommended after initial treatment. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia (if present) has cleared.

Neonates and Infants 1 to 2 months

Very limited data are available; a dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. For neonatal candidiasis, amphotericin B or fluconazole is the preferred therapy. Some experts suggest that if an echinocandin is used in neonates, micafungin is the preferred agent. For endocarditis, treat for at least 6 weeks after valve replacement. For infected cardiac hardware, treat for at least 4 to 6 weeks after hardware removal. When valve replacement or hardware removal is not possible, chronic suppressive therapy with fluconazole is recommended after initial treatment. Treat suppurative thrombophlebitis for at least 2 weeks after candidemia (if present) has cleared.

For the treatment of Aspergillus cardiovascular system infections in patients who are refractory to or intolerant of other antifungal therapies. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily.  Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. After surgical replacement of an infected valve, consider lifelong antifungal therapy.

Infants 3 months and older, Children, and Adolescents

70 mg/m2 IV (Max: 70 mg/dose) loading dose on day 1, followed by 50 mg/m2/dose IV (Max: 70 mg/dose) once daily. If the 50 mg/m2 daily dose is well tolerated but there is an inadequate clinical response, may increase maintenance dose to 70 mg/m2/day (Max: 70 mg/dose). Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. After surgical replacement of an infected valve, consider lifelong antifungal therapy.

Neonates† and Infants 1 to 2 months†

No data are available. A dosage of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Although specific neonatal recommendations are not available, clinical practice guidelines suggest caspofungin as salvage therapy. Treat for at least 6 to 12 weeks with duration dependent on extent and length of immunosuppression, infection site, and disease improvement. After surgical replacement of an infected valve, consider lifelong antifungal therapy.

For the treatment of intraabdominal infections (i.e., peritonitis, intraabdominal abscess) including intraabdominal candidiasis and peritoneal dialysis-related peritonitis†. For the treatment of intraabdominal candidiasis. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants, Children, and Adolescents 3 months to 17 years

70 mg/m2/dose (Max: 70 mg/dose) IV loading dose on day 1, then 50 mg/m2/dose (Max: 70 mg/dose) IV once daily. If the 50 mg/m2 daily dose is well tolerated but the clinical response is inadequate, the maintenance dose may be increased to 70 mg/m2/day (Max: 70 mg/dose) IV once daily. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Neonates† and Infants 1 to 2 months†

Very limited data are available; a dose of 25 mg/m2/dose IV once daily appears to provide comparable exposure to that seen in adults receiving 50 mg IV daily. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Successful treatment of invasive candidiasis has been reported in neonates and young infants; however, available data are limited to small case series and studies. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

For the treatment of peritoneal dialysis-related peritonitis†. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily for at least 14 days after catheter removal for Candida and as salvage therapy for Aspergillus. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

Infants 3 months and older, Children, and Adolescents

70 mg/m2/dose (Max: 70 mg/dose) IV loading dose on day 1, then 50 mg/m2/dose (Max: 70 mg/dose) IV once daily for at least 14 days after catheter removal for Candida and as salvage therapy for Aspergillus. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions.

For candidiasis prophylaxis† and aspergillosis prophylaxis† in high-risk patients. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. An echinocandin, such as caspofungin, is recommended as an alternative therapy to fluconazole for candidiasis prophylaxis in high-risk patients in intensive care units with a high rate (more than 5%) of invasive candidiasis. Clinical practice guidelines suggest caspofungin as an alternative to posaconazole for aspergillosis prophylaxis in high-risk patients (i.e., patients with graft-versus-host disease and neutropenic patients with acute myelogenous leukemia or myelodysplastic syndrome). Also recommended in patients with substantial risk of invasive candidiasis, such as allogeneic hematopoietic stem cell transplant (HSCT) recipients or those undergoing intensive remission-induction or salvage-induction chemotherapy for acute leukemia, and in patients with previous invasive aspergillosis, anticipated prolonged neutropenic periods of at least 2 weeks, or a prolonged period of neutropenia immediately prior to HSCT.

Infants 3 months and older, Children, Adolescents

50 mg/m2/dose IV (Max: 50 mg/dose) once daily. Coadministration of certain drugs may need to be avoided or dosage adjustments may be necessary; review drug interactions. In a retrospective study of pediatric patients (n = 120; 4 months to less than 18 years) undergoing hematopoietic stem cell transplantation (HSCT), caspofungin was initiated on day 1 after HSCT and continued for a median of 24 days (range, 14 to 49 days). An echinocandin, such as caspofungin, is recommended as an alternative therapy to fluconazole for candidiasis prophylaxis in high-risk patients in intensive care units with a high rate (more than 5%) of invasive candidiasis. Clinical practice guidelines suggest caspofungin as an alternative to posaconazole for aspergillosis prophylaxis in high-risk patients (i.e., patients with graft-versus-host disease and neutropenic patients with acute myelogenous leukemia or myelodysplastic syndrome). Also recommended in patients with substantial risk of invasive candidiasis, such as allogeneic HSCT recipients or those undergoing intensive remission-induction or salvage-induction chemotherapy for acute leukemia, and in patients with previous invasive aspergillosis, anticipated prolonged neutropenic periods of at least 2 weeks, or a prolonged period of neutropenia immediately prior to HSCT.

For the treatment of Pneumocystis pneumonia (PCP)† in patients with hematological malignancies, cancer, or autoimmune/inflammatory disease or solid organ transplant recipients. Intravenous dosage Adults

70 mg IV loading dose on day 1, then 50 mg IV once daily in combination with sulfamethoxazole; trimethoprim for 14 to 21 days as salvage therapy. 

Infants, Children, and Adolescents 3 months to 17 years

70 mg/m2/dose (Max: 70 mg/dose) IV loading dose on day 1, then 50 mg/m2/dose (Max: 50 mg/dose) IV once daily in combination with sulfamethoxazole; trimethoprim for 14 to 21 days as salvage therapy. 

Infants 1 to 2 months

25 mg/m2/dose IV once daily in combination with sulfamethoxazole; trimethoprim for 14 to 21 days as salvage therapy. 

†Indicates off-label use

Dosing Considerations
Hepatic Impairment

Dosage adjustment information is only available for adults. No adjustment needed in mild impairment. A reduced maintenance dose of 35 mg/day IV (30% dose reduction) is recommended for patients with moderate hepatic impairment (Child-Pugh score 7 to 9, class B). For pediatric patients, this would be equivalent to a maintenance dose of 35 mg/m2/day. No adjustment in the loading dose is needed. There is no clinical experience in those with severe hepatic impairment (Child-Pugh score more than 9, class C).

Renal Impairment

No dosage adjustment is needed in patients with renal impairment.
 
Intermittent and Continuous Hemodialysis
Caspofungin is not dialyzable. Supplemental dosing is not required following hemodialysis.

Drug Interactions

Carbamazepine: (Major) Data suggest that coadministration of inducers or mixed inducers/inhibitors of hepatic drug clearance along with caspofungin may result in reduced caspofungin blood concentrations. The reductions may be clinically significant. According to the manufacturer, drugs that may lead to reductions in caspofungin concentrations include carbamazepine. For adult patients receiving carbamazepine, an increase in the caspofungin dose to 70 mg/day should be considered. For pediatric patients receiving carbamazepine, a daily dosage of 70 mg/m2, not to exceed 70 mg, should be considered.
Cyclosporine: (Major) In two clinical studies, cyclosporine increased the systemic exposure (AUC) of caspofungin by approximately 35%. Cyclosporine concentrations are not altered by coadministration with caspofungin. Seven of 20 healthy subjects who received caspofungin (35 mg or 70 mg) in combination with cyclosporine (3 mg/kg or 4 mg/kg) developed transient elevations in alanine transaminase (ALT) up to 3 times the upper limit of normal. Elevations in aspartate transaminase (AST) paralleled ALT elevations but were of lesser magnitude. As determined retrospectively, 14 of 40 patients who received caspofungin and cyclosporine (1 to 290 days, median 17.5 days) had an ALT concentration elevation greater than 5 times the upper limit of normal or greater than 3 times the baseline value during concurrent therapy or the following 14 days. Five of the 14 cases and one case of elevated bilirubin were considered possibly related to concomitant therapy; no clinical evidence of hepatotoxicity or serious hepatic events occurred. The manufacturer recommends against the concomitant use of caspofungin with cyclosporine unless the potential benefit outweighs the risk. Monitor patients who develop abnormal liver enzyme concentrations; a risk versus benefit decision for therapy continuation is recommended.
Dexamethasone: (Major) Consider a caspofungin dosage increase if concomitant use with dexamethasone is necessary. Increase the caspofungin dose to 70 mg/day in adults and 70 mg/m2/day (up to 70 mg/day) in pediatric patients. Concomitant use may decrease caspofungin exposure which may reduce its efficacy. Caspofungin is a CYP3A substrate and dexamethasone is a CYP3A inducer.
Dichlorphenamide: (Moderate) Use dichlorphenamide and caspofungin together with caution. Dichlorphenamide increases potassium excretion and can cause hypokalemia and should be used cautiously with other drugs that may cause hypokalemia including antifungals. Measure potassium concentrations at baseline and periodically during dichlorphenamide treatment. If hypokalemia occurs or persists, consider reducing the dichlorphenamide dose or discontinuing dichlorphenamide therapy.
Efavirenz: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving efavirenz. Administering inducers of hepatic cytochrome P450, such as efavirenz, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving efavirenz. Administering inducers of hepatic cytochrome P450, such as efavirenz, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving efavirenz. Administering inducers of hepatic cytochrome P450, such as efavirenz, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
Ethotoin: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving ethotoin. Administering inducers of hepatic cytochrome P450, such as ethotoin, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
Fosphenytoin: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving fosphenytoin. Administering inducers of hepatic cytochrome P450, such as fosphenytoin, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
Isoniazid, INH; Pyrazinamide, PZA; Rifampin: (Major) Dose caspofungin as 70 mg IV once daily for adult patients and 70 mg/m2 (Max: 70 mg/day) IV once daily for pediatric patients when coadministered with rifampin. Coadministration of caspofungin with CYP450 enzyme inducers, such as rifampin, may reduce the plasma concentrations of caspofungin. Rifampin has been shown to decrease caspofungin trough concentrations by 30%.
Isoniazid, INH; Rifampin: (Major) Dose caspofungin as 70 mg IV once daily for adult patients and 70 mg/m2 (Max: 70 mg/day) IV once daily for pediatric patients when coadministered with rifampin. Coadministration of caspofungin with CYP450 enzyme inducers, such as rifampin, may reduce the plasma concentrations of caspofungin. Rifampin has been shown to decrease caspofungin trough concentrations by 30%.
Omeprazole; Amoxicillin; Rifabutin: (Moderate) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving rifabutin. Coadministration of CYP450 enzyme inducers, such as rifabutin, with caspofungin may reduce the plasma concentrations of caspofungin.
Phenytoin: (Major) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving phenytoin. Administering inducers of hepatic cytochrome P450, such as phenytoin, concurrently with caspofungin may reduce the plasma concentrations of caspofungin.
Rifabutin: (Moderate) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving rifabutin. Coadministration of CYP450 enzyme inducers, such as rifabutin, with caspofungin may reduce the plasma concentrations of caspofungin.
Rifampin: (Major) Dose caspofungin as 70 mg IV once daily for adult patients and 70 mg/m2 (Max: 70 mg/day) IV once daily for pediatric patients when coadministered with rifampin. Coadministration of caspofungin with CYP450 enzyme inducers, such as rifampin, may reduce the plasma concentrations of caspofungin. Rifampin has been shown to decrease caspofungin trough concentrations by 30%.
Rifapentine: (Moderate) Consider dosing caspofungin as 70 mg IV once daily in adult patients and 70 mg/m2 IV once daily (Max: 70 mg/day) in pediatric patients receiving rifapentine. Coadministration of CYP450 enzyme inducers, such as rifapentine, with caspofungin may reduce the plasma concentrations of caspofungin.
Tacrolimus: (Moderate) Tacrolimus concentrations are reduced approximately 25% in those patients receiving concurrent caspofungin. The mechanism of this interaction has not been identified; monitor tacrolimus blood concentrations. Increased dosage of tacrolimus may be required. The pharmacokinetic parameters of caspofungin are not altered by tacrolimus.

How Supplied

Cancidas/Caspofungin Intravenous Inj Pwd F/Sol: 50mg, 70mg

Maximum Dosage
Adults

70 mg/day IV; doses up to 150 mg/day IV have been recommended for cardiovascular infections.

Geriatric

70 mg/day IV; doses up to 150 mg/day IV have been recommended for cardiovascular infections.

Adolescents

70 mg/m2/day IV, not to exceed 70 mg IV.

Children

70 mg/m2/day IV, not to exceed 70 mg IV.

Infants

>= 3 months: 70 mg/m2/day IV, not to exceed 70 mg IV.
< 3 months: Safety and efficacy have not been established; however, doses up to 25 mg/m2/day IV are used off-label.

Neonates

Safety and efficacy have not been established; however, doses up to 25 mg/m2/day IV are used off-label.

Mechanism Of Action

Caspofungin inhibits the synthesis of a major fungal cell wall component, beta (1,3)-D-glucan. Beta (1,3)-D-glucan is not present in mammalian cells and therefore is an attractive target for antifungal activity. Morphologically, fungi hyphae and yeast shapes are altered. Caspofungin is fungicidal against Candida sp., and has activity against Aspergillus sp. with hyphae undergoing active cell growth.
 
The following organisms are generally considered susceptible to caspofungin in vitro: Aspergillus sp., including Aspergillus flavus, Aspergillus fumigatus, and Aspergillus terreus, and Candida sp., including Candida albicans, Candida glabrata, Candida guilliermondii, Candida krusei, Candida parapsilosis, and Candida tropicalis. Activity against Trichosporon beigelii, Fusarium sp., and Rhizopus arrhizus is limited. It has no activity against Cryptococcus neoformans, but in vitro has shown synergistic activity against C. neoformans when combined with amphotericin B or fluconazole. In murine models, caspofungin has been shown to have less activity against histoplasmosis than amphotericin B. Standardized susceptibility testing using microbroth dilution methods read at 24 hours are available for Candida sp. The Clinical and Laboratory Standards Institute (CLSI) defines minimum inhibitory concentrations (MICs) for Candida sp. as susceptible if 2 mcg/mL or less and resistant if more than 2 mcg/mL. Currently, there are no established interpretive breakpoints for Aspergillus sp.
 
Resistance to caspofungin resulting in clinical failures has been observed with Candida and Aspergillus sp. In some cases, specific mutations in the Fks subunits (encoded by the fks1 and/or fks2 genes) of the glucan synthase enzyme were identified. These mutations are associated with higher MICs and breakthrough infection. In addition, some Candida sp. that exhibit reduced susceptibility to caspofungin have been found with increased chitin content of the fungal cell wall; the significance of this phenomenon in vivo is not well known. Because of its unique mechanism of action, cross-resistance with amphotericin B and the azoles is not expected.

Pharmacokinetics

Caspofungin is administered by slow intravenous infusion. Distribution, the primary mechanism influencing plasma clearance, follows a three-compartment model.[26421] A short alpha-phase is followed by a beta-phase (half-life of 9 to 11 hours); once-daily dosing is adequate. The final phase (half-life of 40 to 50 hours) results in significant tissue distribution. Animal studies reveal distribution primarily into the liver and kidneys. Caspofungin is 97% bound to serum proteins. Approximately 92% of a 70 mg radiolabeled dose is distributed to tissues within 36 to 48 hours after the dose. There is little excretion or biotransformation during the first 30 hours post-infusion. The clinical significance of the extensive tissue accumulation is unknown but may contribute to the activity of the drug against localized tissue infections. Metabolism occurs by hydrolysis and N-acetylation. Hydrolysis results in two tyrosine amino acid by-products that are rapidly cleared by the kidneys. Chemical degradation leads to the formation of the metabolite L-747969 and very low levels of reactive intermediates. The pathway of chemical degradation is uncertain. Caspofungin does not interact substantially with the cytochrome P450 enzyme system but does undergo significant hepatic metabolism. Single-dose IV administration resulted in excretion of 35% and 41% of the dose in the feces and urine, respectively.[23463] Approximately 1.4% of caspofungin is excreted unchanged in the urine. Metabolites are removed primarily via biliary excretion.[26421]
 
Affected cytochrome P450 isoenzymes: none

Oral Route

Caspofungin has limited oral bioavailability.

Intravenous Route

Plasma concentrations of caspofungin decline in a polyphasic manner following single 1-hour intravenous (IV) infusions. A short alpha-phase occurs immediately post-infusion, followed by a beta-phase (half-life of 9 to 11 hours) that characterizes much of the profile and exhibits clear log-linear behavior from 6 to 48 hours postdose, during which the plasma concentration decreases 10-fold. An additional, longer half-life phase, gamma-phase, (half-life of 40 to 50 hours), also occurs. Distribution, rather than excretion or biotransformation, is the dominant mechanism influencing plasma clearance.

Pregnancy And Lactation
Pregnancy

Data regarding use of caspofungin during human pregnancy are insufficient to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. Based on animal studies, caspofungin may cause fetal harm. Caspofungin crosses the placenta in animal models and is detected in the plasma of animal fetuses. In pregnant rats and rabbits, caspofungin exposure at doses equivalent to 0.8- to 2-times the human clinical dose (based on body surface area comparison) during organogenesis was associated with embryotoxic effects such as increased fetal resorptions, increased peri-implantation loss, and incomplete ossification of the talus/calcaneus, skull, or torso.[28782]

There are no data on the presence of caspofungin in human milk, the effects on the breast-fed child, or the effects on milk production. Caspofungin was detected in the milk of lactating, drug-treated rats. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for caspofungin and any potential adverse effects on the breast-fed child from caspofungin or the underlying maternal condition.[28782]