Caspofungin Acetate
Generic Name: caspofungin acetate
Brand Names:
Caspofungin Acetate
11 DESCRIPTION Caspofungin acetate for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. Caspofungin acetate for Injection is an echinocandin antifungal that inhibits the synthesis of β (1,3)- D-glucan, an integral component of the fungal cell wall.
Overview
11 DESCRIPTION Caspofungin acetate for Injection is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. Caspofungin acetate for Injection is an echinocandin antifungal that inhibits the synthesis of β (1,3)- D-glucan, an integral component of the fungal cell wall.
Uses
1 INDICATIONS AND USAGE Caspofungin acetate for 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. ( 1 ) • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. ( 1 ) • Treatment of esophageal candidiasis. ( 1 ) • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
Dosage
2 DOSAGE AND ADMINISTRATION Important Administration Instructions for All Patients ( 2.1 ): • 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] ( 2.2 ): • 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] ( 2.3 ) : • Dosing should be based on the patient's body surface area.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in detail in another section of the labeling: • Hypersensitivity [see Warnings and Precautions ( 5.1 )] • Hepatic Effects [see Warnings and Precautions ( 5.2 )] • Elevated Liver Enzymes During Concomitant Use with Cyclosporine [see Warnings and Precautions ( 5.3 )] • Adults : Most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased. ( 6.1 ) • Pediatric patients : Most common adverse reactions (incidence 10% or greater) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills.
Interactions
7 DRUG INTERACTIONS Cyclosporine : In two adult clinical studies, cyclosporine (one 4 mg/kg dose or two 3 mg/kg doses) increased the AUC of caspofungin acetate for injection. Caspofungin acetate for injection did not increase the plasma levels of cyclosporine. There were transient increases in liver ALT and AST when caspofungin acetate for injection and cyclosporine were co-administered. Monitor patients who develop abnormal liver enzymes during concomitant therapy and evaluate the risk/benefit of continuing therapy [see Warnings and Precautions ( 5.2 ) and Clinical Pharmacology ( 12.3 )].
Warnings
5 WARNINGS AND PRECAUTIONS • Hypersensitivity : Anaphylaxis, possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm, and cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with use of caspofungin acetate for injection. Discontinue Caspofungin acetate for Injection at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. ( 5.1 ) • Hepatic Effects : Can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported. 4 CONTRAINDICATIONS Caspofungin acetate for Injection is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to any component of this product [see Adverse Reactions ( 6 )] . • Caspofungin acetate for Injection is contraindicated in patients with known hypersensitivity to any component of this product. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on animal data, Caspofungin acetate for Injection may cause fetal harm (see Data ) . There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with Caspofungin acetate for Injection use in pregnant women.
Storage
Storage and Handling The lyophilized vials should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Reconstituted Concentrate Reconstituted Caspofungin acetate for Injection in the vial may be stored at ≤ 25°C (≤ 77°F) for one hour prior to the preparation of the patient infusion solution.
Frequently Asked Questions
What is Caspofungin Acetate used for?▼
1 INDICATIONS AND USAGE Caspofungin acetate for 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. ( 1 ) • Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections. ( 1 ) • Treatment of esophageal candidiasis. ( 1 ) • Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.
What are the side effects of Caspofungin Acetate?▼
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in detail in another section of the labeling: • Hypersensitivity [see Warnings and Precautions ( 5.1 )] • Hepatic Effects [see Warnings and Precautions ( 5.2 )] • Elevated Liver Enzymes During Concomitant Use with Cyclosporine [see Warnings and Precautions ( 5.3 )] • Adults : Most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased. ( 6.1 ) • Pediatric patients : Most common adverse reactions (incidence 10% or greater) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills.
Can I take Caspofungin Acetate during pregnancy?▼
8.1 Pregnancy Risk Summary Based on animal data, Caspofungin acetate for Injection may cause fetal harm (see Data ) . There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with Caspofungin acetate for Injection use in pregnant women.
What are the important warnings for Caspofungin Acetate?▼
5 WARNINGS AND PRECAUTIONS • Hypersensitivity : Anaphylaxis, possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm, and cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with use of caspofungin acetate for injection. Discontinue Caspofungin acetate for Injection at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. ( 5.1 ) • Hepatic Effects : Can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported. 4 CONTRAINDICATIONS Caspofungin acetate for Injection is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to any component of this product [see Adverse Reactions ( 6 )] . • Caspofungin acetate for Injection is contraindicated in patients with known hypersensitivity to any component of this product. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.