Label Changes for:

Letairis (ambrisentan) 5 and 10 mg Tablets

May 2009

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) -- May 2009

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

WARNINGS AND PRECAUTIONS

  • Enroll all patients in LEAP and re-enroll patients after the first 12 months of treatment and annually thereafter
  • Educate and counsel women of childbearing potential to use highly reliable contraception during LETAIRIS treatment and for one month after stopping treatment. If the patient has had a tubal sterilization or chooses to use a Copper T380A IUD or LNg 20 IUS for pregnancy prevention, no additional contraception is needed. Women who do not choose one of these methods should always use two acceptable forms of contraception–one hormone method and one barrier method, or two barrier methods where one method is the male condom.

RISK EVALUATION AND MITIGATION STRATEGY (REMS) 

Goals
  • To encourage informed benefit-risk decisions regarding the use of LETAIRIS
  • To minimize the risk of hepatotoxicity in patients prescribed Letairis
  • To minimize the risk of fetal exposure and adverse fetal outcomes in female patients of childbearing potential prescribed Letairis

Women who are pregnant must not be prescribed Letairis

Women taking Letairis must not become pregnant

MEDICATION GUIDE

  • Medication Guide to be distributed with each 30 day prescription.
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