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For powerful candidemia therapy in adult patients
Make MYCAMINE® the ONE you choose
†Results from a randomized, double-blind, noninferiority study designed to determine the efficacy and safety of MYCAMINE vs Cancidas in 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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NOTE: The efficacy of MYCAMINE against infections caused
by fungi other than Candida has not been established.
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.
References: 1. Data on file, Deerfield, IL: Astellas Pharma US, Inc. 2. Wolters Kluwer Pharma Solutions, Source Non-Retail, January 2009–February 2011. 3. MYCAMINE [package insert]. Deerfield, IL: Astellas Pharma US, Inc; June 2011.
MYCAMINE® is a registered trademark of Astellas.
© 2012 Astellas Pharma US, Inc. All rights reserved. 011I-021-4204-1/12