Posted from: Monday, June 04, 2018 - 11:11 AM - Present

Doptelet Approved to Treat Low Blood Platelet Count

May 21, 2018 – The U.S. FDA has approved Doptelet® (avatrombopag), manufactured by Dova Pharmaceuticals, to treat patients with chronic liver disease (CLD) who have a low blood platelet count (thrombocytopenia) prior to undergoing a surgical or dental procedure.

In clinical trials, Doptelet was shown to increase platelet counts and reduce the need for platelet transfusion or rescue therapy on the day of a patient’s procedure, and for up to seven days thereafter, compared to placebo.

Recommended dosing is based on the patient’s platelet count. For patients who have a count of 40,000/µL to 50,000/µL, the recommended dose is two 20mg tablets once daily with food for five days. Patients whose platelet count is less than 40,000/µL should take three 20mg tablets once daily with food for five days. Treatment with Doptelet should begin 10 to 13 days prior to a scheduled procedure, and the procedure itself should be performed within five to eight days of the last dose of Doptelet.

Dova Pharmaceuticals reports that an estimated 70,000 patients with CLD have a blood platelet count of less than 50,000/µL, which is low enough to introduce the risk of bleeding due to thrombocytopenia. Patients often undergo one to three invasive procedures per year. Serious or uncontrolled bleeding as a result of these procedures can lead to longer hospital stays or other complications.

Doptelet is expected to launch in June, although pricing plans have not yet been announced.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Friday, October 18, 2019 - 01:11 AM.