Prevymis

Letermovir

Prophylaxis of cytomegalovirus (CMV) infection & disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

480 mg once daily. Should be started after HSCT; may be started on the day of transplant & no later than 28 days post-transplant; may be started before or after engraftment. Continue Prevymis through 100 days post-transplant. Co-administration w/ cyclosporine Decrease Prevymis dose to 240 mg once daily. If cyclosporine is initiated after starting Prevymis, decrease next Prevymis dose to 240 mg once daily. If cyclosporine is discontinued after starting Prevymis, increase next Prevymis dose to 480 mg once daily. Conc for soln for infusion: Administer by IV infusion over approx 60 min.

May be taken with or without food: FC tab: Swallow whole, do not divide/crush/chew.

Hypersensitivity. Concomitant administration w/ pimozide; ergot alkaloids; cyclosporine w/ pitavastatin or simvastatin.

Concomitant use w/ drugs that are CYP3A substrates w/ narrow therapeutic ranges (eg, alfentanil, fentanyl, quinidine); closely monitor &/or adjust dose of co-administered CYP3A substrates. Patients w/ -ve CMV DNA test result prior to initiation of prophylaxis; monitor CMV DNA on a wkly basis until post-transplant wk 14 & subsequently bi-wkly until wk 24. Discontinue letermovir prophylaxis & initiate standard-of-care pre-emptive therapy (PET) in cases of clinically significant CMV DNAemia or disease. Continue prophylaxis if PET criteria have not been met in patients in whom letermovir prophylaxis was initiated & baseline CMV DNA test was subsequently found to be +ve. Patients w/ ESRD (CrCl <10 mL/min) including those on dialysis. Closely monitor serum creatinine levels in patients w/ moderate or severe renal impairment (CrCl <50 mL/min). Not recommended for patients w/ severe hepatic impairment (Child-Pugh Class C) & those w/ moderate hepatic impairment combined w/ moderate or severe renal impairment. Pregnancy & lactation. Childn <18 yr. Conc for soln for infusion: Do not administer as IV bolus inj.

Nausea, diarrhea, vomiting; tachycardia, atrial fibrillation.

May increase conc of pimozide leading to QT prolongation & Torsades de pointes; ergot alkaloids which may lead to ergotism. May increase plasma conc when co-administered w/ OATP1B1/3 transporter inhibitors. Potential decreased plasma conc when co-administered w/ strong & moderate inducers of transporters (eg, P-gp) &/or enzymes (eg, UGTs). Initial increased followed by clinically relevant decreased plasma conc when co-administered w/ rifampin. Increased plasma conc of amiodarone, glyburide, atorvastatin, sirolimus, tacrolimus. Plasma conc may be decreased by nafcillin, carbamazepine, phenobarb, rifabutin, thioridazine, bosentan, St. John's wort, efavirenz, etravirine, nevirapine, modafinil. May decrease plasma conc of both letermovir & phenytoin when co-administered. Decreased plasma conc of voriconazole. May decrease plasma conc of warfarin, omeprazole & pantoprazole. Not recommended to be co-administered w/ pitavastatin & simvastatin; significantly increased pitavastatin or simvastatin conc which may lead to myopathy or rhabdomyolysis. May increase plasma conc of other HMG-CoA reductase inhibitors (eg, fluvastatin, lovastatin, pravastatin, rosuvastatin), CYP2C8 substrates (eg, repaglinide, rosiglitazone), CYP3A substrates (eg, alfentanil, fentanyl, midazolam, quinidine). Increased conc of both letermovir & cyclosporine when co-administered.

Antivirals

J05AX18 - letermovir ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.

POM