Letairis (Ambrisentan) - Indications and Dosage

INDICATIONS AND USAGE

LETAIRIS is indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.

DOSAGE AND ADMINISTRATION

Adult Dosage

Initiate treatment at 5 mg once daily with or without food, and consider increasing the dose to 10 mg once daily if 5 mg is tolerated.

Tablets may be administered with or without food. Tablets should not be split, crushed, or chewed. Doses higher than 10 mg once daily have not been studied in patients with pulmonary arterial hypertension (PAH). Liver function tests should be measured prior to initiation and during treatment with LETAIRIS [see Warnings and Precautions ].

Women of Childbearing Potential

Treat women of childbearing potential only after a negative pregnancy test and treat only women who are using two reliable methods of contraception unless the patient has had a tubal sterilization or a Copper T 380A IUD or LNg 20 IUD inserted. In those cases, no other contraception is needed. Pregnancy tests should be obtained monthly in women of childbearing potential taking LETAIRIS [see Contraindications].

Pre-existing Hepatic Impairment

LETAIRIS is not recommended in patients with moderate or severe hepatic impairment [see Special Populations]. Use caution in patients with mild hepatic impairment.

DOSAGE FORMS AND STRENGTHS

LETAIRIS is available as 5 mg and 10 mg film - coated, unscored tablets.

HOW SUPPLIED/STORAGE AND HANDLING

Because of the risk of liver injury and birth defects, LETAIRIS may be prescribed only through the LETAIRIS Education and Access Program (LEAP) by calling
1-866-664-LEAP (5327) or by logging on to www.letairis.com. Adverse events can also be reported directly via this number.

LETAIRIS film - coated, unscored tablets are supplied as follows:

Package Configuration	Tablet Strength	NDC No.	Description of Tablet; Debossed on Tablet; Size
30 count blister	5 mg	61958 - 0801 - 2	Square convex; pale pink; “5” on side 1 and “GSI” on side 2; 6.6 mm Square
30 count blister	10 mg	61958 - 0802 - 2	Oval convex; deep pink; “10” on side 1 and “GSI” on side 2; 9.8 mm x 4.9 mm Oval

Rx only

Store at 25 °C (77 °F); excursions permitted to 15 - 30 °C (59 - 86 °F) [see USP controlled room temperature]. Store LETAIRIS in its original packaging.