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Label Changes for:

Farydak (panobinostat) 

June 2016

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

June 2016

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity
  • Change of time for females using effective contraception to at least 3 months after the last dose.
  • Change of time for sexually active men to use condoms and for 6 months after last dose.

USE IN SPECIFIC POPULATIONS

Females and Males of Reproductive Potential
  • Change of time for females using effective contraception to at least 3 months after the last dose.
  • Change of time for sexually active men to use condoms and for 6 months after last dose.

PATIENT COUNSELING INFORMATION

Pregnancy
  • Change of time for females using effective contraception to at least 3 months after the last dose.
  • Change of time for  sexually active men to use condoms and for 6 months after last dose.

MEDICATION GUIDE

What should I tell my healthcare provider before taking FARYDAK?

Before you take FARYDAK, tell your healthcare provider about all of your medical conditions, including if you:

  • If you become pregnant while taking FARYDAK, or think you may be pregnant, tell your healthcare provider right away.
  • Change of time for females using effective contraception to at least 3 months after the last dose.
  • Change of time for sexually active men to use condoms and for 6 months after last dose.
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