This injection is an echinocandin antifungal indicated in adults and pediatric patients (3 months of age 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. ? Treatment of esophageal candidiasis. ? Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
Caspofungin is an antifungal drug, and belongs to a new class termed the echinocandins. It is used to treat Aspergillus and Candida infection, and works by inhibiting cell wall synthesis. Antifungals in the echinocandin class inhibit the synthesis of glucan in the cell wall, probably via the enzyme 1,3-beta glucan synthase. There is a potential for resistance development to occur, however in vitro resistance development to Caspofungin by Aspergillus species has not been studied.
Caspofungin inhibits the synthesis of beta-(1,3)-D-glucan, an essential component of the cell wall of Aspergillus species and Candida species. beta-(1,3)-D-glucan is not present in mammalian cells. The primary target is beta-(1,3)-glucan synthase.
Important Administration Instructions for All Patients : ? Administer by slow intravenous (IV) infusion over approximately 1 hour. Do not administer by intravenous (IV) bolus administration. ? Do not mix or co-infuse caspofungin acetate for injection with other medications. Do not use diluents containing dextrose (?-D-glucose). Dosage in Adults [18 years of age and older] : ? Administer a single 70 mg loading dose on Day 1, followed by 50 mg once daily for all indications except esophageal candidiasis. ? For esophageal candidiasis, use 50 mg once daily with no loading dose. Dosage in Pediatric Patients [3 months to 17 years of age] : ? Dosing should be based on the patient?s body surface area. ? For all indications, administer a single 70 mg/m2 loading dose on Day 1, followed by 50 mg/m2 once daily thereafter. ? Maximum loading dose and daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. Dosage Adjustments in Patients with Hepatic Impairment : Reduce dosage for adult patients with moderate hepatic impairment (35 mg once daily, with a 70 mg loading dose on Day 1 where appropriate). Dosage Adjustments in Patients Receiving Concomitant Inducers of Hepatic CYP Enzymes : ? Use 70 mg once daily dose for adult patients on rifampin. ? Consider dose increase to 70 mg once daily for adult patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin. ? Pediatric patients receiving these same concomitant medications may also require an increase in dose to 70 mg/m2 once daily (maximum daily dose not to exceed 70 mg)
Cyclosporine: In two adult clinical studies, cyclosporine (one 4 mg/kg dose or two 3 mg/kg doses) increased the AUC of caspofungin. Caspofungin did not increase the plasma levels of cyclosporine. There were transient increases in liver ALT and AST when caspofungin and cyclosporine were co-administered. Monitor patients who develop abnormal liver enzymes during concomitant therapy and evaluate the risk/benefit of continuing therapy.
Tacrolimus: For patients receiving caspofungin and tacrolimus, standard monitoring of tacrolimus trough whole blood concentrations and appropriate tacrolimus dosage adjustments are recommended.
Inducers of Hepatic CYP Enzymes (Rifampin): Rifampin is a potent CYP3A4 inducer and concomitant administration with caspofungin is expected to reduce the plasma concentrations of caspofungin. Therefore, adult patients on rifampin should receive 70 mg of caspofungin daily and pediatric patients on rifampin should receive 70 mg/m 2 of caspofungin daily (not to exceed an actual daily dose of 70 mg).
Caspofungin is contraindicated in patients with known hypersensitivity to any component of this product
? Adults: diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased. ? Pediatric patients:(incidence 10% or greater) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills
? Pregnancy: Based on animal data, may cause fetal harm.
In 6 healthy subjects who received a single 210 mg dose, no significant adverse reactions
were reported. Multiple doses above 150 mg daily have not been studied. Caspofungin
is not dialyzable.
In clinical trials, one pediatric patient (16 years of age) unintentionally received a single
dose of caspofungin of 113 mg (on Day 1), followed by 80 mg daily for an additional 7
days. No clinically significant adverse reactions were reported.
The lyophilized vials should be stored at 20° to 25°C.
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