Caspofungin
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
CANCIDAS® is indicated in adults and pediatric patients (3 months and older) for:
- Empirical therapy for presumed fungal infections in febrile, neutropenic patients
- Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. CANCIDAS has not been studied in endocarditis, osteomyelitis, and meningitis due to Candida.
- Treatment of esophageal candidiasis.
- Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies (e.g., amphotericin B, lipid formulations of amphotericin B, itraconazole). CANCIDAS has not been studied as initial therapy for invasive aspergillosis.
Dosage
Recommended Dosing in Adult Patients [≥18 years of age]
- The usual dose is 50 mg once daily (following a 70-mg loading dose for most indications). The safety and efficacy of a dose of 150 mg daily (range: 1 to 51 days; median: 14 days) have been studied in 100 adult patients with candidemia and other Candida infections. The efficacy of CANCIDAS at this higher dose was not significantly better than the efficacy of the 50-mg daily dose of CANCIDAS. The efficacy of doses higher than 50 mg daily in the other adult patients for whom CANCIDAS is indicated is not known.
Empirical Therapy
A single 70-mg loading dose should be administered on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be based on the patient's clinical response. Empirical therapy should be continued until resolution of neutropenia. Patients found to have a fungal infection should be treated for a minimum of 14 days; treatment should continue for at least 7 days after both neutropenia and clinical symptoms are resolved. If the 50-mg dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg.
Candidemia and Other Candida Infections
A single 70-mg loading dose should be administered on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be dictated by the patient's clinical and microbiological response. In general, antifungal therapy should continue for at least 14 days after the last positive culture. Patients who remain persistently neutropenic may warrant a longer course of therapy pending resolution of the neutropenia.
Esophageal Candidiasis
The dose is 50 mg once daily for 7 to 14 days after symptom resolution. A 70-mg loading dose has not been studied for this indication. Because of the risk of relapse of oropharyngeal candidiasis in patients with HIV infections, suppressive oral therapy could be considered.
Invasive Aspergillosis
A single 70-mg loading dose should be administered on Day 1, followed by 50 mg once daily thereafter. Duration of treatment should be based upon the severity of the patient's underlying disease, recovery from immunosuppression, and clinical response.
Patients with Hepatic Impairment
Adult patients with mild hepatic impairment (Child-Pugh score 5 to 6) do not need a dosage adjustment. For adult patients with moderate hepatic impairment (Child-Pugh score 7 to 9), CANCIDAS 35 mg once daily is recommended based upon pharmacokinetic data. However, where recommended, a 70-mg loading dose should still be administered on Day 1. There is no clinical experience in adult patients with severe hepatic impairment (Child-Pugh score >9) and in pediatric patients with any degree of hepatic impairment.
Patients Receiving Concomitant Inducers of Drug Clearance
- Adult patients on rifampin should receive 70 mg of CANCIDAS once daily. Adult patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin may require an increase in dose to 70 mg of CANCIDAS once daily.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Caspofungin in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Caspofungin in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Recommended Dosing in Pediatric Patients [3 months to 17 years of age]
- For all indications, a single 70-mg/m2 loading dose should be administered on Day 1, followed by 50 mg/m2 once daily thereafter. The maximum loading dose and the daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. Dosing in pediatric patients (3 months to 17 years of age) should be based on the patient's body surface area (BSA) as calculated by the Mosteller Formula
- Following calculation of the patient's BSA, the loading dose in milligrams should be calculated as BSA (m2) X 70 mg/m2. The maintenance dose in milligrams should be calculated as BSA (m2) X 50 mg/m2.
- Duration of treatment should be individualized to the indication, as described for each indication in adults. If the 50-mg/m2 daily dose is well tolerated but does not provide an adequate clinical response, the daily dose can be increased to 70 mg/m2 daily (not to exceed 70 mg).
Patients Receiving Concomitant Inducers of Drug Clearance
When CANCIDAS is co-administered to pediatric patients with inducers of drug clearance, such as rifampin, efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, a CANCIDAS dose of 70 mg/m2 once daily (not to exceed 70 mg) should be considered
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Caspofungin in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Caspofungin in pediatric patients.
Contraindications
There is limited information regarding Caspofungin Contraindications in the drug label.
Warnings
There is limited information regarding Caspofungin Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Caspofungin Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Caspofungin Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Caspofungin Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Caspofungin in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Caspofungin in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Caspofungin during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Caspofungin in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Caspofungin in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Caspofungin in geriatric settings.
Gender
There is no FDA guidance on the use of Caspofungin with respect to specific gender populations.
Race
There is no FDA guidance on the use of Caspofungin with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Caspofungin in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Caspofungin in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Caspofungin in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Caspofungin in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Caspofungin Administration in the drug label.
Monitoring
There is limited information regarding Caspofungin Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Caspofungin and IV administrations.
Overdosage
There is limited information regarding Caspofungin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Caspofungin Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Caspofungin Mechanism of Action in the drug label.
Structure
There is limited information regarding Caspofungin Structure in the drug label.
Pharmacodynamics
There is limited information regarding Caspofungin Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Caspofungin Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Caspofungin Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Caspofungin Clinical Studies in the drug label.
How Supplied
There is limited information regarding Caspofungin How Supplied in the drug label.
Storage
There is limited information regarding Caspofungin Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Caspofungin Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Caspofungin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Caspofungin Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Caspofungin Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [4]
Overview
Caspofungin (INN[1]) (brand name Cancidas worldwide) is a lipopeptide antifungal drug from Merck & Co., Inc.. It is a member of a new class of antifungals termed the echinocandins. It works by inhibiting the enzyme (1→3)-β-D-glucan synthase and thereby disturbing the integrity of the fungal cell wall. Caspofungin was the first inhibitor of fungal (1→3)-β-D-glucan synthesis to be approved by the United States Food and Drug Administration.[2] Caspofungin is administered intravenously.
Category
Antifungal
US Brand Names
CANCIDAS®
FDA Package Insert
Description | Clinical Pharmacology | Microbiology | Indications and Usage | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Overdosage | Clinical Studies | Dosage and Administration | How Supplied | Labels and Packages
Mechanism of Action
References
- ↑ European Medicines Agency's list of authorised medicines for human use (C)
- ↑ Deresinski SC; Stevens DA (2003). "Caspofungin". Clin Infect Dis. 36 (11): 1445&ndash, 1457. doi:10.1086/375080. PMID 12766841. Unknown parameter
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