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- Patient Information:
Details with Side Effects
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
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).
Pregnancy Testing In Females Of Reproductive Potential
Initiate treatment with Letairis in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy tests during treatment [see Use In Specific Populations].
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 film-coated, tablets are supplied as follows:
|Tablet Strength||Package Configuration||NDC No.||Description of Tablet; Debossed on Tablet; Size|
|5 mg||30 count blister||61958-0801-2||Square convex; pale pink; “5” on side 1 and “GSI” on side 2; 6.6 mm Square|
|30 count bottle||61958-0801-1|
|10 count blister||61958-0801-3|
|10 count bottle||61958-0801-5|
|10 mg||30 count blister||61958-0802-2||Oval convex; deep pink; “10” on side 1 and “GSI” on side 2; 9.8 mm x 4.9 mm Oval|
|30 count bottle||61958-0802-1|
|10 count blister||61958-0802-3|
|10 count bottle||61958-0802-5|
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.
Gilead Sciences, Inc., Foster City, CA 94404. Revised January 2014
Last reviewed on RxList: 2/13/2014
This monograph has been modified to include the generic and brand name in many instances.
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