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Zontivity ™ - vorapaxar

Zontivity ™ - vorapaxar. Manufacturer: Merck FDA Approval Date: May 8, 2014 Stephanie Roach, PharmD Candidate. Zontivity ™ - vorapaxar Clinical Application. Indications:

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Zontivity ™ - vorapaxar

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  1. Zontivity™ - vorapaxar Manufacturer: Merck FDA Approval Date: May 8, 2014 Stephanie Roach, PharmD Candidate

  2. Zontivity™ - vorapaxar Clinical Application • Indications: • Reduction of thrombotic CV events in patients with a history of MI or with PAD, in combination with aspirin and/or clopidogrel • Place in therapy: • Secondary prevention in patients with high risk of thrombosis, low risk of bleeding

  3. Zontivity™ - vorapaxar Clinical Application • Black Box Warnings: • Do not use in patients with a history of stroke, TIA or ICH, or active pathological bleeding • Antiplatelet agents increase the risk of bleeding, including ICH and fatal bleeding • Contraindications: • History of stroke, TIA, ICH • Active Pathologic Bleeding

  4. Zontivity™ - vorapaxar Clinical Application • Warnings & Precautions: • General risk of bleeding • 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. • Avoid concomitant use with strong CYP3A inhibitors or inducers

  5. Zontivity™ - vorapaxar Clinical Application • Pregnancy: • Category B • Lactation: • It is unknown whether vorapaxar or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions, discontinue nursing or discontinue vorapaxar.

  6. Zontivity™ - vorapaxarDrug Facts • Pharmacology: • Reversible antagonist of protease-activated receptor-1 (PAR-1) • Long t1/2 makes it effective irreversible • Inhibits thrombin-induced and thrombin receptor agonist peptide (TRAP)-Induced platelet aggregation

  7. Zontivity™ - vorapaxarDrug Facts • Pharmacokinetics:

  8. Zontivity™ - vorapaxarDrug Facts • Pharmacodynamics: • Onset: At least 80% inhibition of TRAP-induced platelet aggregation w/in 1 week. • Duration: Dose & concentration dependent • Inhibition of TRAP-induced platelet aggregation at a level of 50% can be expected 4 weeks after discontinuation.

  9. Zontivity™ - vorapaxar Drug Interactions • Drug Interactions – Object Drugs: •  antiplatelet effect of other antiplatelet agents •  bleeding risk with anticoagulants

  10. Zontivity™ - vorapaxar Drug Interactions • Drug Interactions – Precipitant Drugs: • Strong CYP3A inhibitors  vorapaxar • Ex: ketoconazole, clarithromycin, ritonavir • Strong CYP3A inducers  vorapaxar • Ex: rifampin, carbamazepine, St. John’s Wort and phenytoin

  11. Zontivity™ - vorapaxar Adverse Effects

  12. Zontivity™ - vorapaxar Monitoring Parameters • Efficacy Monitoring: • N/A • Toxicity Monitoring: • Hgb/HCT • S/Sx of bleeding

  13. Zontivity™ - vorapaxar Prescription Information • Dosing: Take one 2.08 mg tablet* by mouth once daily, with or without food • Cost: 2.08 mg (30), $320.76 • Per LexiComp via Uptodate, 09/29/14

  14. Zontivity™ - vorapaxar Literature Review • Purpose: To evaluate the efficacy and safety of vorapaxar during long-term treatment of patients with established atherosclerotic disease receiving standard therapy • Design: phase III, randomized, double-blind, placebo-controlled, international Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  15. Zontivity™ - vorapaxar Literature Review Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  16. Zontivity™ - vorapaxar Literature Review • Baseline Characteristics: Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  17. Zontivity™ - vorapaxar Literature Review • Treatment: 2.08 mg vorapaxar daily vs matching placebo • Standard therapy: • 94% treated with aspirin • 66.5% treated with thienopyridine Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  18. Zontivity™ - vorapaxar Literature Review • Primary Endpoint: Composite of CV death, MI or stroke • Secondary Endpoint: CV death, MI, stroke or urgent revascularization • Major Safety Endpoint: moderate or severe bleeding (GUSTO criteria) Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  19. Zontivity™ - vorapaxar Literature Review • Results: Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  20. Zontivity™ - vorapaxar Literature Review • Safety Endpoints: Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  21. Zontivity™ - vorapaxar Literature Review • Conclusions: • Vorapaxar (in addition to standard therapy) reduced the risk of CV death, MI, or stroke in pts with a history of atherothrombosis, at the cost of increased bleeding • Benefit was particularly evident in patients whose qualifying diagnosis was MI Morrow DA, et al., N Engl J Med. 2012;366:1404-13.

  22. Zontivity™ - vorapaxar Summary • Vorapaxar may added to standard therapy to prevent recurrent thrombotic events in patients with a history of atherosclerosis • Vorapaxar should be reserved for patients with a HIGH risk of thrombosis and LOW risk of bleeding • Vorapaxar is associated with a significant risk of bleeding

  23. Zontivity™ - vorapaxar References • Zontivity Package Insert.Merck. May 2014. Include ALL article references in standard format. • Morrow DA, et al., N Engl J Med. 2012;366:1404-13. • http://www.zontivity.com

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