Prevymis

Letermovir

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

480 mg once daily after HSCT. May be started on the day of transplant & no later than 28 days post-transplant, or before or after engraftment. Continue prophylaxis through 100 days post-transplant. Decrease dose to 240 mg once daily if co-administered w/ cyclosporine.

May be taken with or without food: Swallow whole. Do not divide/crush/chew.

Hypersensitivity. Concomitant administration w/ pimozide; ergot alkaloids; St. John's wort (Hypericum perforatum). If combined w/ cyclosporine, concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated.

Monitor CMV DNA on a wkly basis until post-transplant wk 14, & subsequently every 2 wk until wk 24. Stop prophylaxis in cases of clinically significant CMV DNAemia or disease. Caution w/ CYP3A substrates w/ narrow therapeutic ranges (eg, alfentanil, fentanyl, quinidine); cyclosporine, tacrolimus, sirolimus; voriconazole; OATP1B1/3 substrates (eg, statins). Avoid concomitant use w/ dabigatran. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Prophylaxis for >100 days requires careful assessment of the benefit-risk balance. Minor influence on the ability to drive or use machines. Not recommended in patients w/ severe hepatic impairment (Child-Pugh C); patients w/ moderate hepatic impairment (Child-Pugh B) combined w/ moderate or severe renal impairment. Efficacy & safety has not been demonstrated in patients w/ ESRD. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue breast-feeding, or discontinue/abstain from Prevymis therapy during lactation. Safety & efficacy in patients <18 yr have not been established.

Nausea, diarrhoea, vomiting.

Subtherapeutic exposure w/ strong (eg, rifampicin, phenytoin, carbamazepine, St. John's wort, rifabutin, phenobarb) & moderate (eg, thioridazine, modafinil, ritonavir, lopinavir, efavirenz, etravirine) inducers of transporters &/or enzymes. Decreased plasma conc w/ rifampicin. Increased plasma conc w/ OATP1B1/3 inhibitors (eg, cyclosporine, gemfibrozil, erythromycin, clarithromycin, & several PIs [atazanavir, simeprevir]). Decreased plasma exposure & reduced efficacy of medicinal products mainly eliminated through metabolism or influenced by active transport; CYP2C9 &/or CYP2C19 substrates (eg, warfarin, voriconazole, diazepam, lansoprazole, omeprazole, esomeprazole, pantoprazole, tilidine, tolbutamide). Increased plasma conc of CYP3A substrates (eg, midazolam, certain immunosuppressants [eg, cyclosporine, tacrolimus, sirolimus], HMG-CoA reductase inhibitors, amiodarone, pimozide, ergot alkaloids); OATP1B1/3 substrates (eg, HMG-CoA reductase inhibitors, fexofenadine, repaglinide, glyburide); OAT3 substrates (eg, ciprofloxacin, tenofovir, imipenem, cilastatin). Concomitant use w/ CYP2C8 substrates (eg, repaglinide) is not recommended. Decreased plasma conc of intestinal P-gp substrates (eg, dabigatran, sofosbuvir). Increased or decreased plasma conc of CYP2B6 substrates (eg, bupropion); UGT1A1 substrates (eg, raltegravir, dolutegravir); BRCP substrates (eg, rosuvastatin, sulfasalazine); OATP2B1 substrates (eg, celiprolol).

Antivirals

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

P₁S₁S₃