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 daily thereafter.
Maximum loading dose and daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose.
Dosing With Rifampin and Other Inducers of Drug Clearance ( 2.5):

Use 70 mg daily dose of CANCIDAS for adult patients on rifampin.
Consider dose increase to 70 mg CANCIDAS 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 daily (maximum daily dose not to exceed 70 mg).

DOSAGE FORMS AND STRENGTHS
CANCIDAS 50 mg is a white to off-white powder/cake for infusion in a vial with a red aluminum band and a plastic cap. The vial contains 54.6 mg of caspofungin. ( 3)
CANCIDAS 70 mg is a white to off-white powder/cake for infusion in a vial with a yellow/orange aluminum band and a plastic cap. The vial contains 75.6 mg of caspofungin. ( 3)

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

WARNINGS AND PRECAUTIONS
Concomitant use of CANCIDAS with cyclosporine should be limited to patients for whom the potential benefit outweighs the potential risk. Patients who develop abnormal liver function tests during concomitant therapy should be monitored and the risk/benefit of continuing therapy should be eva luated. ( 5.1)
Abnormalities in liver function tests and isolated cases of clinically significant hepatic dysfunction, hepatitis, and hepatic failure have been reported. Patients who develop abnormal liver function tests during CANCIDAS therapy should be monitored for evidence of worsening hepatic function and eva luated for risk/benefit of continuing CANCIDAS therapy. ( 5.2)

ADVERSE REACTIONS
Possible histamine-mediated symptoms have been reported. ( 6.1)
Most common adverse reactions for CANCIDAS (incidence ≥10%) in ADULTS: diarrhea, pyrexia, chills, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased. ( 6.1)
Most common adverse reactions (incidence ≥10%) in PEDIATRIC PATIENTS: pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills. ( 6.2)

To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
 
USE IN SPECIFIC POPULATIONS
Pregnancy – No human data. Adverse effects in animals. Use if potential benefits of treatment outweigh potential fetal risk. ( 8.1)
Based upon pharmacokinetic data, a dosage reduction is recommended for adult patients with moderate hepatic insufficiency (35 mg daily, with a 70-mg loading dose on Day 1 where appropriate). ( 12.3)
Safety and efficacy of CANCIDAS in neonates and infants less than 3 months old has not been established. ( 8.4)

See 17 for PATIENT COUNSELING INFORMATION 

Revised: 08/2008
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

1. INDICATIONS AND USAGE
1.1 Empirical therapy for presumed fungal infections in febrile, ne