Once-Daily LETAIRIS
5 mg and 10 mg film-coated tablets

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Risk Evaluation and Mitigation Strategy (REMS):
Click here to learn more about the LETAIRIS REMS program
and the risk of birth defects.
Please see the IMPORTANT SAFETY INFORMATION tab for complete risk information, including boxed WARNING
on the risk of serious birth defects, and full prescribing information for complete details.
Gilead
INDICATION: LETAIRIS is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-III symptoms and etiologies of idiopathic or heritable PAH (64%) or PAH associated with connective tissue diseases (32%).

Clinical worsening was defined as the first occurrence of death, lung transplantation, hospitalization for PAH, atrial septostomy, study withdrawal due to the addition of other PAH therapeutic agents, or study withdrawal due to early escape.1

Early escape criteria were two or more of the following after a minimum treatment period of 4 weeks: 20% decrease in 6MWD; worsening WHO functional class; worsening right ventricular failure; rapidly progressing cardiac, hepatic, or renal failure; and refractory systolic hypotension <85 mm Hg.1,2

BOXED WARNING: CONTRAINDICATED IN PREGNANCY
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 [see Contraindications (4.1)]. 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 special restricted distribution program called the LETAIRIS Education and Access Program (LEAP), by calling 1-866-664-LEAP (5327). Only prescribers and pharmacies registered with LEAP may prescribe and distribute LETAIRIS. In addition, LETAIRIS may be dispensed only to patients who are enrolled in and meet all conditions of LEAP [see Warnings and Precautions (5.1)].

Please see the IMPORTANT SAFETY INFORMATION tab for complete risk information, including boxed WARNING on the risk of serious birth defects, and full prescribing information for complete details.

References: 1. LETAIRIS [Prescribing Information]. Foster City, Calif: Gilead Sciences, Inc; July 2011. 2. Galiè N, Olschewski H, Oudiz RJ, et al, for the Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies (ARIES) Group. Ambrisentan for the treatment of pulmonary arterial hypertension: results of the Ambrisentan in Pulmonary Arterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy (ARIES) Study 1 and 2. Circulation. 2008;117(23):3010-3019.