Vorapaxar

Bleeding

Non-CABG-Related Bleeds in Post-MI or PAD Patients without a History of Stroke or TIA

• Severe (1%)
• Moderate or severe (3%)
• Any bleeding (25%)
• Fatal bleeding (0.2%)
• Intracranial hemorrhage (0.4%)
• Clinically significant bleeding (15.5%)
• GI bleeding (4.7%)

1-10%

Anemia (5%)

Depression (2.4%)

Rashes, eruptions, exanthemas (2.2%)

<1%

Diplopia (0.2%)

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• imatinib;
• nefazodone;
• St. John's wort;
• an antibiotic--clarithromycin, telithromycin;
• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;
• heart or blood pressure medicine--nicardipine, quinidine;
• antiviral medicine to treat hepatitis or HIV/AIDS--atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir;
• seizure medicine--carbamazepine, phenytoin; or
• tuberculosis medicine--isoniazid, rifampin.

Other drugs may interact with vorapaxar, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Vorapaxar is part of the drug class:

• Platelet aggregation inhibitors excl. heparin

Serious side effects have been reported with vorapaxar. See the “Vorapaxar Precautions” section.

Common side effects of vorapaxar include the following:

• Bleeding, including life-threatening and fatal bleeding
• Anemia
• Depression
• Rashes

This is not a complete list of vorapaxar side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Store vorapaxar at 20-25°C (68-77°F).
• Keep this and all medicines out of the reach of children.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• imatinib;

• nefazodone;

• St. John's wort;

• an antibiotic--clarithromycin, telithromycin;

• antifungal medicine--itraconazole, ketoconazole, posaconazole, voriconazole;

• heart or blood pressure medicine--nicardipine, quinidine;

• antiviral medicine to treat hepatitis or HIV/AIDS--atazanavir, boceprevir, cobicistat, delavirdine, efavirenz, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, telaprevir;

• seizure medicine--carbamazepine, phenytoin; or

• tuberculosis medicine--isoniazid, rifampin.

Other drugs may interact with vorapaxar, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Zontivity: 2.08 mg

Do not use vorapaxar in patients with a history of stroke, transient ischemic attack, or intracranial hemorrhage; or active pathological bleeding. Antiplatelet agents, including vorapaxar, increase the risk of bleeding, including intracranial hemorrhage and fatal bleeding.

Adverse events have not been observed in animal reproduction studies.

2.08 mg orally once a day, with or without food

Comments: Use with aspirin and/or clopidogrel

Uses: For reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD)

Administration advice:
-Administer with or without food.
-Use this drug with aspirin and/or clopidogrel according to indications or standard of care.

Patient advice:
-This drug should not be discontinued without physician advice.
-Report any unanticipated, prolonged or excessive bleeding, or blood in stool or urine.
-Inform physicians and dentists that you are taking this drug before any surgery or dental procedure.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: B Comments: There are no adequate and well-controlled studies of the use of this drug in pregnant women.

No embryofetal toxicities, malformations or maternal toxicities were observed in rats exposed during gestation. An overall increase in the number of litters with any malformation was observed at the highest dose, where systemic exposures were 89-fold higher than the human exposure at the recommended human dose. There are no controlled data in human pregnancy. FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Use should be avoided. Excreted into human milk: Unknown Excreted into animal milk: Yes