Generic Name and Formulations:
Ambrisentan 5mg, 10mg; tabs.

Company:
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.

Adult:
In females: initiate only after (–) pregnancy test. Swallow whole. Initially 5mg once daily; may increase to 10mg once daily if tolerated. Concomitant cyclosporine: max 5mg once daily.

Children:
Not established.

Contraindications:
Pregnancy (Cat.X). Idiopathic pulmonary fibrosis including IPF patients with pulmonary hypertension (WHO Group 3).

Warnings/Precautions:
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.

Interactions:
Potentiated by cyclosporine.

Pharmacological Class:
Endothelin receptor antagonist.

Adverse Reactions:
Peripheral edema, nasal congestion, sinusitis, flushing, elevated liver enzymes; decreased sperm counts, hematologic changes.

Note:
For all female patients: available only through the Letairis REMS program. To enroll call (866) 664-5327 or www.letairisrems.com.

REMS:
YES

How Supplied:
Tabs—10, 30