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eltrombopag (AKR-501, Promacta)

Indications: 1) thrombocytopenia (investigational) - ITP, chronic liver disease, chemotherapy-induced 2) FDA approved for patients who have failed at least one standard therapy for ITP 3) adjunctive treatment for aplastic anemia Contraindications: - not indicated for the treatment of thrombocytopenia in patients with chronic liver disease [4] Dosage: - 20-75 mg PO QD - dosing should be amined at increasing platelet count to a level that reduces the risk of bleeding, not normalizing platelet count [4] Monitor: - serum AST & serum ALT & serum bilirubin at baseline, every 2 weeks during dosage adjustment & monthly when dose is stable [6] Adverse effects: - none noted [2] - hepatotoxicity [4,5] - bone marrow toxicity [5] - nausea, vomiting, & minor transaminase increases [3] - portal vein thrombosis [4] Mechanism of action: - thrombopoietin receptor agonist - 20-40% of patients respond [2,4] - most responders achieve platelet counts of > 50,000/uL within 15 days, - thrombocytopenia relapses after cessation of treatment Notes: - patients, pharmacies, & prescribers must be registered with Promacta CARES [5] - noninstitutional retail pharmacies are not eligible to dispense Promacta

General

thrombopoietin receptor agonist

References

  1. Jenkins JM et al, Phase 1 clinical study of eltrombopag, an oral nonpepeptide thrombopoietin receptor agonist. Blood 2007, 109:4739 PMID: 17327409
  2. Bussel JB et al, Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med 2007, 357:2237 PMID: 18046028 - McHutchison JG et al, Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med 2007, 357::2227 PMID: 18046027
  3. Bussel JB et al. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: A randomised, double-blind, placebo-controlled trial. Lancet 2009 Feb 21; 373:641. PMID: 19231632
  4. FDA Medwatch Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm211796.htm
  5. Promacta CARES http://www.promacta.com (877) 9-PROMACTA
  6. Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: 260704 (subscription needed) http://www.prescribersletter.com
  7. Saleh MN et al. Safety and efficacy of eltrombopag for treatment of chronic immune thrombocytopenia (ITP): Results of the long-term, open-label EXTEND study. Blood 2012 Nov 20 PMID: 23169778 http://www.bloodjournal.org/cgi/doi/10.1182/blood-2012-04-425512
  8. Townsley DM, Scheinberg P, Winkler T et al Eltrombopag Added to Standard Immunosuppression for Aplastic Anemia. N Engl J Med 2017; 376:1540-1550. April 20, 2017 PMID: 28423296 http://www.nejm.org/doi/full/10.1056/NEJMoa1613878