†Results from a randomized, double-blind, noninferiority study designed to determine the efficacy and safety of MYCAMINE vs Cancidas in adult patients with documented invasive candidiasis or candidemia (patients with Candida endocarditis, osteomyelitis, and meningitis were excluded from the analyses). Patients were administered MYCAMINE 100 mg/day (n=191) or Cancidas 70-mg loading dose followed by 50-mg maintenance dose (n=188). Outcome was assessed by overall treatment success based on clinical and mycological response at the end of IV therapy. All patients received at least 1 dose of study medication.
‡Treatment difference (and 95% confidence interval) for MYCAMINE vs Cancidas in the total patient population was 7.4% (−2.0% to 16.3%).
full prescribing information
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MYCAMINE is indicated in adult and pediatric patients 4 months and older for:
- Treatment of candidemia, acute disseminated candidiasis, Candida,
- 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.
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. In these cases, MYCAMINE should be discontinued and appropriate treatment administered.
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.
In clinical trials, possible histamine-mediated symptoms have been reported with MYCAMINE (including rash, pruritus, facial swelling, and vasodilatation).
In clinical trials, the most common treatment-emergent adverse reactions in adults for all indications included diarrhea, nausea, vomiting, pyrexia, thrombocytopenia, and headache. The most common treatment-emergent adverse reactions observed in pediatric patients 4 months and older included vomiting, diarrhea, pyrexia, nausea, abdominal pain, and thrombocytopenia.
Reference: 1. MYCAMINE® (micafungin sodium) for injection [package insert]. Northbrook, IL: Astellas Pharma US, Inc.