Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
vorapaxar sulfate (UNII: IN66038E6C) (vorapaxar - UNII:ZCE93644N2)
Merck Sharp & Dohme Corp.
vorapaxar sulfate
vorapaxar 2.08 mg
PRESCRIPTION DRUG
New Drug Application
ZONTIVITY- VORAPAXAR TABLET, FILM COATED MERCK SHARP & DOHME CORP. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZONTIVITY SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZONTIVITY. ZONTIVITY (VORAPAXAR) TABLETS 2.08 MG*, FOR ORAL USE *EQUIVALENT TO 2.5 MG VORAPAXAR SULFATE INITIAL U.S. APPROVAL: 2014 WARNING: BLEEDING RISK _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ DO NOT USE ZONTIVITY IN PATIENTS WITH A HISTORY OF STROKE, TRANSIENT ISCHEMIC ATTACK (TIA), OR INTRACRANIAL HEMORRHAGE (ICH); OR ACTIVE PATHOLOGICAL BLEEDING. (4.1, 4.2) ANTIPLATELET AGENTS, INCLUDING ZONTIVITY, INCREASE THE RISK OF BLEEDING, INCLUDING ICH AND FATAL BLEEDING. (5.1) INDICATIONS AND USAGE ZONTIVITY is a protease-activated receptor-1 (PAR-1) antagonist indicated for the reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD). ZONTIVITY has been shown to reduce the rate of a combined endpoint of cardiovascular death, MI, stroke, and urgent coronary revascularization. (1.1) DOSAGE AND ADMINISTRATION One tablet of ZONTIVITY orally once daily. (2.1) Use with aspirin and/or clopidogrel according to their indications or standard of care. There is limited clinical experience with other antiplatelet drugs and none with ZONTIVITY as the only antiplatelet agent. (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 2.08 mg vorapaxar. (3) CONTRAINDICATIONS History of stroke, TIA, or ICH. (4.1) Active pathologic bleeding. (4.2) WARNINGS AND PRECAUTIONS Like other antiplatelet agents, ZONTIVITY increases the risk of bleeding. (5.1) Avoid use with strong CYP3A inhibitors or inducers. (5.2) ADVERSE REACTIONS Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MERCK SHARP & DOHME CORP., A SUBSIDIARY OF MERCK & CO., INC., AT 1-877-888-4231 OR FDA AT 1-800-FDA-1088 OR WWW.FDA Soma hati kamili