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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].
DOSAGE AND ADMINISTRATION
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. Issued: October 2013.
Last reviewed on RxList: 11/5/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Opsumit Information
Report Problems to the Food and Drug Administration
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