ZONTIVITY- vorapaxar sulfate tablet, film coated
Merck Sharp & Dohme Corp.
WARNING: BLEEDING RISK
•Do not use ZONTIVITY in patients with a history of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH); or active pathological bleeding [see CONTRAINDICATIONS (4.1, 4.2)].
•Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding [see Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
1.1 Patients with History of Myocardial Infarction (MI) or with Peripheral Arterial Disease (PAD)
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 (UCR).
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
Take one tablet of ZONTIVITY 2.08 mg orally once daily, with or without food.
2.2 Coadministration with Other Antiplatelet Drugs
There is no experience with use of ZONTIVITY alone as the only administered antiplatelet agent. ZONTIVITY has been studied only as an addition to aspirin and/or clopidogrel. Use ZONTIVITY with aspirin and/or clopidogrel according to their indications or standard of care [see Clinical Studies (14)]. There is limited clinical experience with other antiplatelet drugs.
3 DOSAGE FORMS AND STRENGTHS
ZONTIVITY tablets, 2.08 mg vorapaxar, are yellow, oval-shaped, film-coated tablets with “351″ on one side and the Merck logo on the other side.
4 CONTRAINDICATIONS
4.1 History of Stroke, Transient Ischemic Attack (TIA), or Intracranial Hemorrhage (ICH)
ZONTIVITY is contraindicated in patients with a history of stroke, TIA, or ICH because of an increased risk of ICH in this population [see Adverse Reactions (6)].
5 WARNINGS AND PRECAUTIONS
5.1 General Risk of Bleeding
Antiplatelet agents, including ZONTIVITY, increase the risk of bleeding, including ICH and fatal bleeding [see Adverse Reactions (6.1)].
ZONTIVITY increases the risk of bleeding in proportion to the patient’s underlying bleeding risk. Consider the underlying risk of bleeding before initiating ZONTIVITY. General risk factors for bleeding include older age, low body weight, reduced renal or hepatic function, history of bleeding disorders, and use of certain concomitant medications (e.g., anticoagulants, fibrinolytic therapy, chronic nonsteroidal anti-inflammatory drugs [NSAIDS], selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors) increases the risk of bleeding [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)]. Avoid concomitant use of warfarin or other anticoagulants.
Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), or other surgical procedures.
Withholding ZONTIVITY for a brief period will not be useful in managing an acute bleeding event because of its long half-life. There is no known treatment to reverse the antiplatelet effect of ZONTIVITY. Significant inhibition of platelet aggregation remains 4 weeks after discontinuation [see Overdosage (10) and Clinical Pharmacology (12.2, 12.3)].
5.2 Strong CYP3A Inhibitors or Inducers
Strong CYP3A inhibitors increase and ind |
