July 28, 2016
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How Supplied


Pulmonary Arterial Hypertension

OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). OPSUMIT also reduced hospitalization for PAH.

Effectiveness was established in a long-term study in PAH patients with predominantly WHO Functional Class II-III symptoms treated for an average of 2 years. Patients were treated with OPSUMIT monotherapy or in combination with phosphodiesterase-5 inhibitors or inhaled prostanoids. Patients had idiopathic and heritable PAH (57%), PAH caused by connective tissue disorders (31%), and PAH caused by congenital heart disease with repaired shunts (8%) [see Clinical Studies].


Recommended Dosage

The recommended dosage of OPSUMIT is 10 mg once daily for oral administration. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended.

Pregnancy Testing In Females Of Reproductive Potential

Initiate treatment with OPSUMIT in females of reproductive potential only after a negative pregnancy test. Obtain monthly pregnancy test during treatment [see Use in Specific Populations].


Dosage Forms And Strengths

Tablets: 10 mg, bi-convex film-coated, round, white, and debossed with “10” on one side.

Storage And Handling

OPSUMIT tablets are 10 mg white, film-coated, bi-convex debossed with “10” on one side and supplied as follows:

15 count /PVC/ PE/PVDC aluminum foil blisters in carton (NDC 66215-501-15)
30 count white high-density polyethylene bottle in carton (NDC 66215-501-30)

Store at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature].

Manufactured for: Actelion Pharmaceuticals US, Inc. 5000 Shoreline Court, Ste. 200 South San Francisco, CA 94080, USA. Revised: June 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/1/2016

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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