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U.S. Department of Health and Human Services

Safety

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Mycamine (micafungin sodium) For Injection


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Candidemia and Other Candida Infections
      • Table 2
    • Esophageal Candidiasis
      • Table 3
    • Prophylaxis of Candida Infections in Hematopoietic Stem Cell Transplant Recipients
      • Table 4
    • Overall Mycamine Safety Experience in Clinical Trials
      • Blood and Lymphatic System Disorders
      • Gastrointestinal Disorders
      • Table 5

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

  • Geriatric Use
  • Race and Gender

CONTRAINDICATIONS

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