Label Changes for:
Letairis (ambrisentan) Tablets
February 2012
Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) - October 2010, March 2011 and February 2012
February 2012
BOXED WARNING
- Do not administer Letairis to a pregnant woman because it may cause fetal harm. Letairis is very likely to produce serious birth defects if used by pregnant women, as this effect has been seen consistently when it is administered to animals.
- Pregnancy must therefore be excluded before the initiation of treatment with Letairis and prevented during treatment and for one month after stopping treatment by the use of two acceptable methods of contraception unless the patient has had a tubal sterilization or chooses to use a Copper T 380A IUD or LNg 20 IUS, in which case no additional contraception is needed. Obtain monthly pregnancy tests.
- Because of the risk of birth defects, Letairis is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Letairis Education and Access Program (LEAP). As a component of the Letairis REMS, prescribers, patients, and pharmacies must enroll in the program.
