Skip to Content

Label Changes for:

Zytiga (abiraterone acetate) Tablets

May 2015

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

May 2015

ADVERSE REACTIONS

Post Marketing Experience
  • addition of... Musculoskeletal and Connective Tissue Disorders: myopathy, including rhabdomyolysis.

 

January 2015

DRUG INTERACTIONS

Effects of Abiraterone on Drug Metabolizing Enzymes
  • In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with ZYTIGA.

 

May 2014

6 ADVERSE REACTIONS

6.2 Post Marketing Experience...addition of non-infectious pneumonitis

 

December 2012

CONTRAINDICATIONS

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