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LETAIRIS is 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%).
DOSAGE AND ADMINISTRATION
Healthcare professionals who prescribe LETAIRIS must enroll in the restricted program called LEAP and must comply with the required monitoring to ensure safe use of LETAIRIS [see WARNINGS AND PRECAUTIONS].
Initiate treatment at 5 mg once daily, 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).
Women of Childbearing Potential
Dosage Forms And Strengths
- 5 mg and 10 mg film-coated tablets for oral administration
- Each 5 mg tablet is square convex, pale pink, with “5” on one side and “GSI” on the other side.
- Each 10 mg tablet is oval convex, deep pink, with “10” on one side and “GSI” on the other side.
Storage And Handling
LETAIRIS is available only through the LETAIRIS Education and Access Program (LEAP) by calling 1-866-664-LEAP (5327) or by logging on to www.letairis.com.
LETAIRIS film-coated, 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|
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.
Revised February 2012. Gilead Sciences, Inc., Foster City, CA 94404
Last reviewed on RxList: 2/24/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Letairis Information
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