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U.S. Department of Health and Human Services

Safety

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Zytiga (abiraterone acetate) Tablets

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

 

December 2012

Summary View

 

CONTRAINDICATIONS

Pregnancy: 
  • Zytiga can cause fetal harm when administered to a pregnant woman. Zytiga is not indicated for use in women…
 

WARNINGS AND PRECAUTIONS

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess:
  • Zytiga may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition…
Adrenocortical Insufficiency
  • Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking Zytiga and in 0.2% of patients taking placebo…
Hepatotoxicity
  • In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received Zytiga, typically during the first 3 months after starting treatment…

 

September 2012

7 ADVERSE REACTIONS

7.1 Drug Interaction, Effects of Abiraterone on Drug Metabolizing Enzymes
  • ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid coadministration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3)].

 

July 2012 

Summary View

 

ADVERSE REACTIONS

  • Fracture