Caspofungin Acetate - Caspofungin Acetate injection, Powder, Lyophilized, For Solution

(Caspofungin Acetate)

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Caspofungin Acetate - Caspofungin Acetate injection, Powder, Lyophilized, For Solution Prescribing Information

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.

• 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.

Important Administration Instructions For All Patients (2.1):

• Administer by slow intravenous (IV) infusion over approximately 1 hour. Do not administer by 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.

• For all indications, administer a single 70-mg/m
² loading dose on Day 1, followed by 50 mg/m
² once daily thereafter.

• Maximum loading dose and daily maintenance dose should not exceed70 mg, regardless of the patient's calculated dose.

Dosage Adjustments in Patients with Hepatic Impairment (2.4)

Reduce dosage for adult patients with moderate hepatic impairement (35 mg once daily, with a 70 mg loading doase on Day1 where appropriate)

Dosage Adjustments in Patients Receiving Concomitant Inducers of Hepatic CYP Enzymes (2.5):

• 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/m
² once daily (maximum daily dose not to exceed 70 mg).

Caspofungin Acetate for Injection 50 mg is a white to off-white lyophilized cake or powder for reconstitution in a single-dose glass vial with an aluminum seal and a plastic cap. Caspofungin acetate for injection 50 mg vial contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate.

Caspofungin Acetate for Injection 70 mg is a white to off-white lyophilized cake or powder for reconstitution in a single-dose glass vial with an aluminum seal and a plastic cap. Caspofungin acetate for injection 70 mg vial contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate.

•

Pregnancy

: Based on animal data, may cause fetal harm. (8.1)

•

Pediatric use

: Safety and efficacy in neonates and infants less than 3 months old have not been established. (8.4)

•

Hepatic Impairment

: Reduce dose for adult patients with moderate hepatic impairment {35 mg once daily, with a 70-mg loading dose on Day 1 where appropriate). No data are available in adults with severe impairment or in pediatric patients with any degree of impairment. (2.4,8.6, 12.3)

•

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. Discontinue caspofungin 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. Monitor patients who develop abnormal liver enzymes for evidence of worsening hepatic function, and evaluate risk/benefit of continuing caspofungin. (5.2)

•

Elevated Liver Enzymes D

uring Concomitant Use with Cyclosporine: Limit use to patients for whom potential benefit outweighs potential risk. Monitor patients who develop abnormal liver function tests (LFTs) during concomitant use with caspofungin. (5.3)

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Caspofungin Acetate - Caspofungin Acetate injection, Powder, Lyophilized, For Solution

Caspofungin Acetate - Caspofungin Acetate injection, Powder, Lyophilized, For Solution Prescribing Information

Caspofungin Acetate - Caspofungin Acetate injection, Powder, Lyophilized, For Solution PubMed™ News