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Letairis (ambrisentan) is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of the lungs.
Letairis (ambrisentan) prevents thickening of the blood vessels, especially those in the lungs and heart. Ambrisentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.
Updates to the Letairis patient enrollment process What has changed? Due to changes in the FDA-mandated REMS enrollment process, there are now two separate patient enrollment forms.
2 FULL PRESCRIBING INFORMATION WARNING: EMBRYO-FETAL TOXICITY Do not administer Letairis to a pregnant female because it may cause fetal harm.
THE AMBITION TRIAL Expert Presentation of the Use of Initial Combination Therapy in Pulmonary Arterial Hypertension (PAH) The AMBITION trial was the first and only long-term, event-driven, PAH outcomes trial designed to study the effects of initial combination therapy with Letairis® (ambrisentan) + tadalafil in treatment-naïve patients with ...
Download Letairis REMS Materials. In order to ensure that Letairis is prescribed and taken safely, Gilead has worked with the FDA to develop materials for the Letairis REMS Program to inform prescribers and patients about the risk of serious birth defects.
-- First-Line Combination of Letairis and Tadalafil Reduced Risk of Disease Progression by Nearly 50 Percent Compared to Either Therapy Individually in Study of 605 PAH Patients with WHO Functional Class II-III Symptoms --
The Letairis Risk Evaluation and Mitigation Strategy (REMS) Program A Risk Evaluation and Mitigation Strategy is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks.
n engl j med 373;9 nejm.orgAugust 27, 2015 835 Ambrisentan–Tadalafil in Pulmonary Arterial Hypertension R egardless of the initiating trig-ger, pulmonary arterial hypertension re-
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