Zontivity Generic Name & Formulations
Legal Class
Rx
General Description
Vorapaxar 2.08mg (equivalent to 2.5mg of vorapaxar sulfate); tabs.
Pharmacological Class
Protease-activated receptor-1 (PAR-1) antagonist.
How Supplied
Tabs—30, 90
Manufacturer
Generic Availability
NO
Zontivity Indications
Indications
To reduce thrombotic cardiovascular events in patients with a history of myocardial infarction or with peripheral arterial disease.
Zontivity Dosage and Administration
Adult
2.08mg once daily. Use with aspirin and/or clopidogrel according to their indications or standard of care.
Children
Not established.
Zontivity Contraindications
Contraindications
History of stroke, transient ischemic attack (TIA), or intracranial hemorrhage (ICH). Active pathological bleeding (eg, peptic ulcer, ICH).
Zontivity Boxed Warnings
Boxed Warning
Bleeding risk.
Zontivity Warnings/Precautions
Warnings/Precautions
Discontinue if stroke, TIA, or ICH occurs. Increased risk of bleeding (may be fatal). Consider underlying risk of bleeding before initiating (eg, older age, low body wt., reduced renal or hepatic function, history of bleeding disorders, concomitant certain medications). Hypotensive and has recently undergone coronary angiography, PCI, CABG or other surgeries: suspect bleeding and monitor. Severe hepatic impairment: not recommended. Elderly. Pregnancy. Nursing mothers: not recommended.
Zontivity Pharmacokinetics
See Literature
Zontivity Interactions
Interactions
Avoid concomitant strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, conivaptan). Avoid concomitant strong CYP3A4 inducers (eg, rifampin, carbamazepine, St. John’s wort, phenytoin). Avoid concomitant warfarin or other anticoagulants. Increased risk of bleeding with concomitant fibrinolytics, chronic NSAIDs, SSRIs, SNRIs.
Zontivity Adverse Reactions
Adverse Reactions
Bleeding (may be fatal), anemia, depression, rashes, eruptions, exanthemas, iron deficiency, retinopathy or retinal disorder, diplopia/oculomotor disturbances.
Zontivity Clinical Trials
See Literature
Zontivity Note
Not Applicable
Zontivity Patient Counseling
See Literature