"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1):
- To improve exercise ability and delay clinical worsening.
- In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability [see Clinical Studies].
Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
DOSAGE AND ADMINISTRATION
Initiate treatment at 5 mg once daily, with or without tadalafil 20 mg once daily. At 4-week intervals, either the dose of Letairis or tadalafil can be increased, as needed and tolerated, to Letairis 10 mg or tadalafil 40 mg.
Do not split, crush, or chew tablets.
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: October 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/16/2015
Additional Letairis Information
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