Medication Monitor

Generic Name (Trade Name—Company)
November 21, 2017


(Prevymis—Merck Sharp & Dohme)
Agent prevents CMV exposure after allogeneic stem cell transplant

FDA has approved letermovir once-daily tablets for oral use and injection for I.V. infusion to prevent cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

CMV is a common and potentially serious viral infection in allogeneic HSCT recipients. CMV-seropositive patients who undergo an HSCT are at high risk for CMV reactivation. Any level of CMV infection is associated with increased mortality in patients with HSCT.

Letermovir is contraindicated in patients receiving pimozide or ergot alkaloids. Increased pimozide concentrations may lead to QT prolongation and torsades de pointes. Increased ergot alkaloids concentrations may lead to ergotism. The drug is contraindicated with pitavastatin and simvastatin when coadministered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.

Recommended dosage is 480 mg administered once daily, initiated as early as Day 0 and up to Day 28 posttransplantation (before or after engraftment), and continued through Day 100 posttransplantation. If letermovir is coadministered with cyclosporine, the dosage of oral or I.V. drug should be decreased to 240 mg once daily.

Letermovir is available as 240-mg and 480-mg tablets that may be administered with or without food and as 240-mg and 480-mg injection for I.V. infusion via a peripheral catheter or central venous line at a constant rate over 1 hour.

The drug is expected to be available in December 2017.