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 was defined as meeting two or more of the following criteria: a 20% decrease in the 6-minute walk distance; an increase in WHO functional class; worsening right ventricular failure; rapidly progressing cardiogenic, hepatic, or renal failure, or refractory systolic hypotension.1
Boxed WARNING: Contraindicated in pregnancy
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 [see Contraindications (4)].
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 [see Warnings and Precautions (5.1)].
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 [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.