MYCAMINE

Adults The pharmacokinetics of micafungin were determined in healthy subjects, hematopoietic stem cell transplant recipients, and patients with esophageal candidiasis up to a maximum daily dose of 8 mg/kg body weight. The relationship of area under the concentration-time curve (AUC) to micafungin dose was linear over the daily dose range of 50 mg to 150 mg and 3 mg/kg to 8 mg/kg body weight. Typically, 85% of the steady-state concentration is achieved after three daily MYCAMINE doses. Steady-sta...

14.1 Treatment of Candidemia and Other Candida Infections in Adult and Pediatric Patients 4 Months of Age and Older Two dose levels of MYCAMINE were evaluated in a randomized, double-blind study to determine the efficacy and safety versus caspofungin in patients with invasive candidiasis and candidemia. Patients were randomized to receive once daily intravenous infusions (IV) of MYCAMINE, either 100 mg/day or 150 mg/day or caspofungin (70 mg loading dose followed by 50 mg maintenance dose). Patients in both study arms were permitted to switch to oral fluconazole after at least 10 days of intra...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )]
• Hematological Effects [see Warnings and Precautions ( 5.2 )]
• Hepatic Effects [see Warnings and Precautions ( 5.3 )]
• Renal Effects [see Warnings and Precautions ( 5.4 )]
• Infusion and Injection Site Reactions [see Warnings and Precautions ( 5.5 )]
• Most common adverse reactions across adult and pediatric clinical trials for all...

MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins. MYCAMINE is contraindicated in persons with known hypersensitivity to micafungin sodium, any component of MYCAMINE, or other echinocandins. ( 4 )

• Hypersensitivity Reactions: Anaphylaxis and anaphylactoid reactions (including shock) have been observed. Discontinue MYCAMINE and administer appropriate treatment. ( 5.1 )
• Hematological Effects: Isolated cases of acute intravascular hemolysis, hemolytic anemia and hemoglobinuria have been reported. Monitor rate of hemolysis. Discontinue if severe. ( 5.2 )
• Hepatic Effects: Abnormalities in liver tests; isolated cases of hepatic impairment, hepatitis, and hepatic failure have been observed....

7 DRUG INTERACTIONS Monitor for sirolimus, itraconazole or nifedipine toxicity, and dosage of sirolimus, itraconazole or nifedipine should be reduced, if necessary. ( 7 ) 7.1 Effect of Other Drugs on MYCAMINE CYP3A4, CYP2C9 and CYP2C19 Inhibitors Co-administration of MYCAMINE with cyclosporine, itraconazole, voriconazole and fluconazole did not alter the pharmacokinetics of MYCAMINE. CYP2C19 and C...