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Letairis (Ambrisentan) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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

Adult Dosage

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.

HOW SUPPLIED/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 × 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 1530° C (5986° F) [see USP controlled room temperature]. Store Letairis in its original packaging.

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