To view the full prescribing information for MYCAMINE, select the link on the left labeled Full Prescribing Information.

MYCAMINE is an antifungal agent consisting of micafungin sodium that is administered by intravenous injection. MYCAMINE belongs to the antifungal class of echinocandins and exerts its effect by inhibiting the synthesis of 1,3-ß-D-glucan, an integral component of the fungal cell wall.

MYCAMINE is indicated for (see Indications for complete details):

Treatment of patients with Candidemia, Acute disseminated candidiasis Candida peritonitis and abscesses MYCAMINE has not been adequately studied in patients with endocarditis, osteomyelitis and meningitis due to Candida infections Treatment of patients with esophageal candidiasis Prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation

NOTE: The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.

MYCAMINE is the first echinocandin approved for prophylaxis.

MYCAMINE has been studied in over 3500 subjects in 41 clinical trials and is found to have a safety profile comparable to fluconazole and caspofungin. For clinically supported details regarding the safety profile of MYCAMINE, see the Adverse Reactions section.

MYCAMINE should be administered by intravenous infusion over 1 hour; no loading dose is required. No dose adjustments are required based on race or gender, in patients with mild-to-moderate hepatic insufficiency, or in patients with severe renal dysfunction. The effect of severe hepatic impairment on micafungin pharmacokinetics has not been studied. Specific administration instructions, as well as dosage details for each indication, are presented in the Dosing & Administration section.

Potential drug-drug interactions with MYCAMINE have been well studied in 14 studies. Drug-drug interaction details, between MYCAMINE and other medications anticipated to be administered concomitantly with MYCAMINE, are described in the Drug Interactions section.

Clinical study evidence supporting the efficacy and safety of MYCAMINE can be found in the Pivotal Trials section.

Important Safety Information

MYCAMINE is contraindicated in patients with known hypersensitivity to micafungin, any component of MYCAMINE, or other echinocandins.

Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE.

Elevations in BUN and creatinine, and isolated cases of clinically significant hepatic dysfunction, hepatitis, hepatic failure, renal dysfunction, acute renal failure, hemolysis, or hemolytic anemia have occurred in some patients who have received MYCAMINE. Patients who develop these conditions, or abnormal liver or renal function tests, should be monitored closely for worsening function and evaluated for risk/benefit of continuing MYCAMINE therapy.

Adverse events with MYCAMINE included possible histamine-mediated symptoms (including rash, pruritus, facial swelling and vasodilatation).

The most common treatment-emergent adverse reactions included diarrhea, nausea, vomiting, pyrexia, hypokalemia, thrombocytopenia, and headache.