Empirical Therapy in Febrile Neutropenic Patients: Caspofungin acetate for injection is used as empirical treatment for suspected fungal infections in febrile neutropenic adult and pediatric patients (3 months of age and older).

Candidemia and Other Candida Infections: It is indicated for the treatment of candidemia and other Candida infections, including intra-abdominal abscesses, peritonitis, and pleural space infections in adults and children (≥3 months).

Esophageal Candidiasis: Indicated for the treatment of esophageal candidiasis in adult and pediatric patients (≥3 months).

Invasive Aspergillosis: Used in adults and pediatric patients (≥3 months) with invasive aspergillosis who are refractory to or intolerant of other antifungal therapies.

Caspofungin is an antifungal agent belonging to the echinocandin class. It exerts its effect by inhibiting fungal cell wall synthesis, specifically targeting the enzyme responsible for β-(1,3)-D-glucan production. This component is essential for the structural integrity of fungal cell walls in organisms such as Candida and Aspergillus species. Since β-(1,3)-D-glucan is absent in mammalian cells, this mechanism provides selective toxicity. Although resistance may develop, its occurrence in Aspergillus species has not been fully established.

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 (α-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. The 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 a 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: Co-administration increases caspofungin exposure (AUC) and may cause transient elevation of liver enzymes (ALT/AST); monitor liver function and assess risk-benefit.

Tacrolimus: Monitoring of tacrolimus blood levels is recommended, with appropriate dose adjustment when used together.

Rifampin (CYP Inducer): Rifampin may reduce caspofungin plasma levels; therefore, higher dosing (up to 70 mg daily) may be required in adults and adjusted dosing in pediatric patients.

Caspofungin is contraindicated in patients with known hypersensitivity to any component of the formulation.

Adults: Common adverse effects (≥10%) include diarrhea, fever (pyrexia), increased ALT/AST levels, elevated alkaline phosphatase, and decreased blood potassium.

Pediatric Patients: Common adverse effects (≥10%) include fever, diarrhea, rash, elevated ALT/AST, decreased potassium levels, hypotension, and chills.

Caspofungin is classified as pregnancy category C. There are no adequate and well-controlled studies in pregnant women. Animal studies have shown embryo-fetal toxicity, including increased resorptions, peri-implantation loss, and incomplete ossification at multiple fetal sites. Therefore, it should be used during pregnancy only if the potential benefit justifies the possible risk to the fetus. It is not known whether caspofungin is excreted in human milk, although it has been detected in the milk of lactating animals. As many drugs are excreted in human milk, caution should be exercised when administered to nursing mothers.

Hypersensitivity reactions, including anaphylaxis, have been reported; if they occur, caspofungin should be discontinued and appropriate treatment initiated. Histamine-mediated reactions such as rash, facial swelling, angioedema, pruritus, warmth, or bronchospasm may also occur and may require discontinuation or treatment.

Caspofungin may cause abnormalities in liver enzymes, and cases of hepatic dysfunction, hepatitis, and hepatic failure have been reported. Patients with abnormal liver function tests should be monitored carefully, and continuation of therapy should be evaluated based on risk and benefit.

During concomitant use with cyclosporine, there may be an increased risk of abnormal liver enzymes; therefore, use should be limited to situations where the potential benefit outweighs the risk, and liver function tests should be monitored.

Other Antifungal preparations

The lyophilized vials should be stored at 20° to 25°C.