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U.S. Department of Health and Human Services

Safety

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Vidaza (azacitidine) for Injection

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

 

January 2014

Summary View

5 WARNINGS AND PRECAUTIONS

5.3 Renal Abnormalities
  • Deleted the statement, “Safety and effectiveness of VIDAZA in patients with MDS and renal impairment have not been studied as these patients were excluded from the clinical trials.”

8 USE IN SPECIFIC POPULATIONS

8.8 Renal Impairment

new section added

  • Severe renal impairment has no major effect on the PK exposure of azacitidine after single and multiple SC administrations. Therefore, azacitidine can be administered to subjects with renal impairment without initial dose adjustment [see Clinical Pharmacology (12.3)

 

January 2012

Summary View

 

ADVERSE REACTIONS

Postmarketing Experience
  • tumor lysis syndrome, injection site necrosis,and Sweet’s syndrome (acute febrile neutrophilic dermatosis) ....added