ZONTIVITY vorapaxar tablet film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

vorapaxar sulfate (UNII: IN66038E6C) (vorapaxar - UNII:ZCE93644N2)

Saatavilla:

Merck Sharp & Dohme Corp.

INN (Kansainvälinen yleisnimi):

vorapaxar sulfate

Koostumus:

vorapaxar 2.08 mg

Prescription tyyppi:

PRESCRIPTION DRUG

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

ZONTIVITY- VORAPAXAR TABLET, FILM COATED
MERCK SHARP & DOHME CORP.
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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