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Important Safety Information and Indications
MYCAMINE is contraindicated in patients with known hypersensitivity to micafungin, any of its components, or other echinocandins.
Warnings and Precautions
Hypersensitivity Reactions: Isolated cases of serious hypersensitivity (anaphylaxis and anaphylactoid) reactions (including shock) have been reported in patients receiving MYCAMINE. If these reactions occur, MYCAMINE should be discontinued and appropriate treatment administered.
Hematological Effects: Isolated cases of significant hemolysis and hemolytic anemia have been reported. Patients developing clinical or laboratory evidence should be monitored closely.
Hepatic Effects: In some patients with serious underlying conditions who were receiving MYCAMINE along with multiple concomitant medications, clinical hepatic abnormalities have occurred, and isolated cases of significant hepatic impairment, hepatitis, and hepatic failure have been reported. Patients who develop abnormal liver function tests should be monitored for evidence of worsening hepatic function and evaluate for the risk/benefit of continuing MYCAMINE therapy.
Renal Effects: Elevations in BUN and creatinine, and isolated cases of significant renal impairment or acute renal failure have been reported. Patients who develop abnormal renal function tests should be monitored for worsening renal function.
Infusion Reactions: Possible histamine-mediated symptoms have been reported with MYCAMINE including rash, pruritus, facial swelling, and vasodilatation. Injection site reactions, including phlebitis and thrombophlebitis have been reported, and tended to occur more often with peripheral intravenous administration.
The most common adverse reactions include diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, and headache.
Indications and Usage
MYCAMINE is indicated in adult and pediatric patients 4 months and older for:
- Treatment of 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.
Please see full Prescribing Information.