Generic Name and Formulations:
Ambrisentan 5mg, 10mg; tabs.
Gilead Sciences, Inc.
Indications for LETAIRIS:
Pulmonary arterial hypertension (PAH) (WHO Group I) in patients with WHO Class II or III symptoms to improve exercise ability and delay clinical worsening, or in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
In females: initiate only after (–) pregnancy test. Swallow whole. Initially 5mg once daily, with or without tadalafil 20mg once daily. At 4-week intervals, either Letairis or tadalafil dose may be increased, as needed and tolerated, to Letairis 10mg or tadalafil 40mg. Concomitant cyclosporine: max 5mg once daily.
Pregnancy (Cat.X). Idiopathic pulmonary fibrosis including those patients with pulmonary hypertension (WHO Group 3).
Embryo-fetal toxicity: in females of reproductive potential, exclude pregnancy prior to starting, monthly during, and for 1 month after treatment; must use acceptable methods of contraception. Monitor for significant fluid retention and pulmonary edema; discontinue if pulmonary veno-occlusive disease develops. Monitor hemoglobin prior to initiation, at one month, and periodically thereafter; consider discontinuing if significant decrease in hemoglobin develops. Clinically significant anemia: not recommended. Moderate to severe hepatic impairment: not recommended. Discontinue if ALT, AST elevations >5xULN or if elevations accompanied by bilirubin >2xULN, or by signs/symptoms of liver dysfunction and other causes excluded. Nursing mothers: not recommended.
Potentiated by cyclosporine. Increased peripheral edema with concomitant tadalafil.
Endothelin receptor antagonist.
Peripheral edema, nasal congestion, sinusitis, flushing, elevated liver enzymes; decreased sperm counts, hematologic changes; in combination with tadalafil: also headache, cough, anemia, dyspepsia, bronchitis.
For all female patients: available only through the Letairis REMS program. To enroll call (866) 664-5327 or www.letairisrems.com.