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U.S. Department of Health and Human Services

Safety

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Vidaza (azacitidine for injection) For SC or IV Use August 2008


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 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. Read about the new physician labeling format.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Anemia, Neutropenia and Thrombocytopenia
  • Pregnancy: Pregnancy Category D
  • Use in Males

ADVERSE REACTIONS

  • Overview
    • Adverse Reactions Described in Other Labeling Sections
      • Anemia (added)
    • Adverse Reactions Most Frequently (>2%) Resulting in Clinical Intervention (SC or IV Route)
      • Dose Held
        • ...thrombocytopenia, pyrexia, pneumonia (added)
  • Adverse Reactions in Clinical Trials
    • Initial Section
    • Table 1
    • Table 2
  • In clinical studies of either SC or IV Vidaza, the following serious adverse reactions occurring at a rate of < 5% (and not described in Tables 1 or 2) were reported:
    • Blood and Lymphatic System Disorders
      • Bone marrow failure
      • Pancytopenia
    • Eye Disorders
      • Eye Hemorrhage
    • Infections and Infestations
      • Cellulitis
      • Neutropenic sepsis
      • Septic shock
    • Nervous System Disorders
      • Cerebral hemorrhage
  • Postmarketing Experience

USE IN SPECIFIC POPULATIONS

  • Pregnancy - Pregnancy Category D
    • ...Female partners of male patients receiving Vidaza should not become pregnant [see Nonclinical Toxicology (13)]...
  • Nursing Mothers
    • ...a decision should be made whether to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother.
  • Geriatric Use
  • Gender
  • Race

PATIENT COUNSELING INFORMATION

  • ...For nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into consideration the importance of the drug to the mother.

WARNINGS AND PRECAUTIONS

Anemia, Neutropenia and Thrombocytopenia

Treatment with Vidaza is associated with anemia, neutropenia and thrombocytopenia... (anemia added)

Pregnancy: Pregnancy Category D

...Azacitidine caused congenital malformations in animals...[see Use in Specific Populations (8.1)].

Use in Males

...In animal studies, pre-conception treatment of male mice and rats resulted in increased embryofetal loss in mated females [see Nonclinical Toxicology (13)].
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