CANCIDAS 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. (1)

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 CANCIDAS 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/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 (2.4):

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 Adjustment 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/m2 once daily (maximum daily dose not to exceed 70 mg).

• For Injection: 50 or 70 mg lyophilized powder (plus allowance for overfill) in a single-dose vial for reconstitution (3)

• CANCIDAS is contraindicated in patients with known hypersensitivity to any component of this product. (4)

• Hypersensitivity:

  Anaphylaxis has been reported. If this occurs, discontinue CANCIDAS and administer appropriate treatment

  Possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm have been reported and may require discontinuation and/or administration of 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 eva luate risk/benefit of continuing CANCIDAS. (5.2)
• Abnormal Liver Enzymes during 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 CANCIDAS. (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%) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills. (6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• 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 hepatic impairment. (2.4, 8.6, 12.3)