Rx Item-Opsumit 10Mg 30Tab

hese highlights do not include all the information needed to use OPSUMIT safely and effectively. See full prescribing information for OPSUMIT. OPSUMIT � (macitentan) tablets, for oral use Initial U.S. Approval: 2013 WARNING: EMBRYO-FETAL TOXICITY SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING Do not administer OPSUMIT to a pregnant female because it may cause fetal harm (4.1, 5.1, 8.1). Females of reproductive potential: exclude pregnancy before start of treatment, monthly during treatment, and 1 month after stopping treatment. Prevent pregnancy during treatment and for one month after treatment by using acceptable methods of contraception (2.2, 8.6). For all female patients, OPSUMIT is available only through a restricted program called the OPSUMIT Risk Evaluation and Mitigation Strategy (REMS) (5.2). RECENT MAJOR CHANGES Warnings and Precautions (5.4) 03/2017 INDICATIONS AND USAGE 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 (1.1). DOSAGE AND ADMINISTRATION 10 mg once daily. Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended (2.1). DOSAGE FORMS AND STRENGTHS Tablet: 10 mg (3) CONTRAINDICATIONS Pregnancy (4.1) WARNINGS AND PRECAUTIONS ERAs cause hepatotoxicity and liver failure. Obtain baseline liver enzymes and monitor as clinically indicated (5.3). Fluid retention may require intervention (5.4). Decreases in hemoglobin (5.5). Pulmonary edema in patients with pulmonary veno-occlusive disease. If confirmed, discontinue treatment (5.6). Decreases in sperm count have been observed in patients taking ERAs (5.7). ADVERSE REACTIONS Most common adverse reactions (more frequent than placebo by ?3%) are anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection (6.1). To report SUSPECTED ADVERSE REACTIONS, contact Actelion at 1-866-228-3546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS Strong CYP3A4 inducers (rifampin) reduce exposure to macitentan: avoid co-administration with OPSUMIT (7.1, 12.3). Strong CYP3A4 inhibitors (ketoconazole, ritonavir) increase exposure to macitentan: avoid co-administration with OPSUMIT (7.2, 12.3). USE IN SPECIFIC POPULATIONS Nursing mothers: discontinue OPSUMIT or breastfeeding (8.3). See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 3/2017 CLOSE

RX ITEM-Opsumit 10Mg 30Tab
Generic Name: OPSUMIT- macitentan tablet, film coated UPC 366215501306

Opsumit 10Mg 30Tab
BRAND: OPSUMIT- NDC: RX66215-501-30 ,RX6621550130 UPC: 366215-501306,366215501306 Generic Name: OPSUMIT- macitentan tablet, film coated UPC 366215501306

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