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Label Changes for:

Juxtapid (lomitapide) Capsules

March 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)

 

August 2014

DRUG INTERACTIONS

  • * re-categorize the combination of tipranavir/ritonavir from the list of weak CYP3A4 inhibitors to the list of strong CYP3A4 inhibitors.*

 

February 2014

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
  • Pregnancy Exposure Registry…added

17 PATIENT COUNSELING INFORMATION

  • Phone number added for registry program

MEDICATION GUIDE

2. Harm to your unborn baby.

  • If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your doctor right away.
  • Pregnancy Exposure Registry…section added

 

April 2013

 

WARNINGS AND PRECAUTIONS

Risk of Hepatotoxicity
Hepatic Steatosis
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