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Doptelet Approval History

Reviewed on May 23, 2018 by J.Stewart B.Pharm.

  • FDA approved: Yes (First approved May 21st, 2018)
  • Brand name: Doptelet
  • Generic name: avatrombopag
  • Dosage form: Tablets
  • Company: Dova Pharmaceuticals, Inc.
  • Treatment for: Thrombocytopenia

Doptelet (avatrombopag) is a second generation, orally administered thrombopoietin receptor agonist (TPO-RA) indicated for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a medical procedure.

Dosage and Administration

  • Doptelet tablets should be taken orally with food once daily for five consecutive days.
  • Dosing should begin 10 to 13 days prior to the scheduled medical or dental procedure, and the procedure should take place within 5 to 8 days after the last dose.
  • The recommended dose is based on a patient’s platelet count prior to the scheduled procedure.

Warnings and Precautions

Thrombotic/Thromboembolic Complications: Doptelet is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Patients should be monitored carefully.

Adverse Reactions

Most common adverse reactions (≥ 3%) include: pyrexia, abdominal pain, nausea, headache, fatigue, and peripheral edema.

Use In Specific Populations

  • Pregnancy: Pregnant women should be advised of the potential risk to a fetus.
  • Breastfeeding: Patients should not breastfeed during treatment with Doptelet, and for at least two weeks after taking the final dose.

Development History and FDA Approval Process for Doptelet

DateArticle
May 21, 2018Approval FDA Approves Doptelet (avatrombopag) for Chronic Liver Disease Patients with Thrombocytopenia who are Undergoing a Medical Procedure
Nov 27, 2017Dova Pharmaceuticals Announces FDA Acceptance of the Avatrombopag New Drug Application (NDA) with Priority Review
Sep 22, 2017Dova Pharmaceuticals Announces New Drug Application Submission to FDA for Avatrombopag, a Second Generation Thrombopoietin Receptor Agonist

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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