Prevymis

Prevymis

letermovir

Manufacturer:

Merck Sharp & Dohme

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Letermovir
Indications/Uses
Prophylaxis of cytomegalovirus (CMV) reactivation & disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).
Dosage/Direction for Use
480 mg once daily started on transplant day & no later than 28 days post-transplant. Co-administration w/ cyclosporine Decreased to 240 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not chew/crush/divide.
Contraindications
Hypersensitivity. Concomitant use w/ pimozide, ergot alkaloids; cyclosporine w/ dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatin or lovastatin.
Special Precautions
Monitor CVM DNA on wkly basis. Concomitant use w/ CYP3A substrates w/ narrow therapeutic ranges eg, alfentanil, fentanyl, quinidine. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Not recommended in severe hepatic impairment; moderate hepatic impairment w/ moderate or severe renal impairment. ESRD w/ or w/o dialysis. Not recommended in women of childbearing potential & during pregnancy. Lactation. Childn <18 yr.
Adverse Reactions
Drug Interactions
Decreased plasma conc by nafcillin, carbamazepine, St, Johns's wort, phenobarb, phenytoin, rifabutin, rifampicin, thioridazine, modafinil, efavirenz, bosentan, ritonavir, lopinavir, etravirine, nevirapine. Decreased plasma conc of warfarin, dabigatran, voriconazole, PPIs. Increased plasma conc of amiodarone, quinidine, glyburide, statins, HMG-CoA reductase inhibitors, cyclosporine, sirolimus, tacrolimus, CYP2C8 & CYP3A substrates. Reduced plasma conc of other OC steroids. Increased/decreased plasma conc of repaglinide.
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 FC tab 240 mg
Packing/Price
28's
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