Letairis Generic Name & Formulations
Legal Class
Rx
General Description
Ambrisentan 5mg, 10mg; tabs.
Pharmacological Class
Endothelin receptor antagonist.
How Supplied
Tabs—10, 30
Manufacturer
Generic Availability
NO
Letairis Indications
Indications
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.
Letairis Dosage and Administration
Adult
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.
Children
Not established.
Letairis Contraindications
Contraindications
Pregnancy. Idiopathic pulmonary fibrosis including those patients with pulmonary hypertension (WHO Group 3).
Letairis Boxed Warnings
Boxed Warning
Embryo-fetal toxicity.
Letairis Warnings/Precautions
Warnings/Precautions
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.
REMS
Letairis Pharmacokinetics
See Literature
Letairis Interactions
Interactions
Potentiated by cyclosporine; see Adults. Increased peripheral edema with concomitant tadalafil.
Letairis Adverse Reactions
Adverse Reactions
Peripheral edema, nasal congestion, sinusitis, flushing; elevated liver enzymes, decreased sperm counts, hematologic changes; in combination with tadalafil: also headache, cough, anemia, dyspepsia, bronchitis.
Letairis Clinical Trials
See Literature
Letairis Note
Notes
For all female patients: available only through the Ambrisentan REMS program. To enroll call (888) 417-3172 or www.ambrisentanrems.us.com.
Letairis Patient Counseling
See Literature