Uptravi(selexipag)处方使用说明书2015版.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION CONTRAINDICATIONS These highlights do not include all the information needed to use None (4) UPTRAVI® safely and effectively. See full prescribing information for UPTRAVI®. WARNINGS AND PRECAUTIONS Pulmonary edema in patients with pulmonary veno-occlusive disease. UPTRAVI® (selexipag) tablets, for oral use If confirmed, discontinue treatment. (5.1) Initial U.S. Approval: 2015 ADVERSE REACTIONS INDICATIONS AND USAGE Adverse reactions occurring more frequently (5%) on UPTRAVI UPTRAVI® is a prostacyclin receptor agonist indicated for the compared to placebo are headache, diarrhea, jaw pain, nausea, treatment of pulmonary arterial hypertension (PAH, WHO Group I) myalgia, vomiting, pain in extremity, and flushing. (6.1) to delay disease progression and reduce the risk of hospitalization for PAH. (1.1) To report SUSPECTED ADVERSE REACTIONS, contact Actelion at 1-866-228-3546 or FDA at 1-800-FDA-1088 or DOSAGE AND ADMINISTRATION /medwatch.  Starting dose: 200 mcg twice daily. (2.1) DRUG INTERACTIONS  Increase the dose by 200 mcg twice daily at weekly intervals to the highest tolerated dose up to 1600 mcg twice daily. (2.1)