Prevymis

Prevymis

letermovir

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Letermovir
Indications/Uses
Prophylaxis of cytomegalovirus (CMV) infection & disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
Dosage/Direction for Use
IV 480 mg once daily, to be infused over approx 60 min. 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 thorugh 100 days post-transplant. Co-administration w/ cyclosporine: Decrease Prevymis dose to 240 mg once daily. If cyclosporine is initiated after starting Prevymis, decrease the next Prevymis dose to 240 mg once daily. If cyclosporine is discontinued after starting Prevymis, increase the next Prevymis dose to 480 mg once daily.
Contraindications
Hypersensitivity. Concomitant administration w/ pimozide; ergot alkaloids; cyclosporine w/ pitavastatin or simvastatin.
Special Precautions
Not for IV bolus inj. 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/ negative 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 has not been met in patients in whom letermovir prophylaxis was initiated & the baseline CMV DNA test was subsequently found to be positive. Patients w/ end-stage renal disease (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.
Adverse Reactions
Nausea, diarrhea, vomiting; tachycardia, atrial fibrillation.
Drug Interactions
May increase conc of pimozide (leading to QT prolongation & Torsades de pointes) & ergot alkaloids (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. Decreased plasma conc by rifampin. Plasma conc may be decreased by nafcillin, carbamazepine, phenobarb, rifabutin, thioridazine, bosentan, St. John's wort, efavirenz, etravirine, nevirapine, modafinil. May have mutual decrease in plasma conc w/ phenytoin. 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 (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).
MIMS Class
Antivirals
ATC Classification
J05AX18 - letermovir ; Belongs to the class of other antivirals. Used as a direct acting antiviral in the systemic treatment of viral infections.
Presentation/Packing
Form
Prevymis conc for soln for infusion 20 mg/mL
Packing/Price
12 mL x 1's;24 mL x 1's
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