Prevymis Approved for Transplant Patients
November 8, 2017 – The U.S. FDA has approved Prevymis™ (letermovir), manufactured by Merck, as prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Hematopoietic stem cell transplants were formerly known as bone marrow transplants.
Prevymis is the first of a new class of drugs, non-nucleoside cytomegalovirus (CMV) inhibitors, to receive FDA approval. It is also the first drug to be FDA-approved for its indication. Approximately 65-80% of American patients who undergo HSCT are CMV-seropositive, which raises their risk of infection following the procedure.
Recommended dosing for Prevymis is 480mg once daily either by mouth (the drug is available in 240mg and 480mg tablets) or by intravenous (IV) infusion. When given by infusion, the drug should be delivered at a constant rate over a one-hour time period. In the event the patient is also taking cyclosporine, dosage should be decreased to 240mg once per day. Treatment should begin within 28 days of the HSCT procedure, and continue through Day 100 following the HSCT procedure. The intravenous form of Prevymis should only be used in patients who are unable to take the drug orally. Monitoring for CMV reactivation is recommended following the full course of prophylaxis treatment.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.