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. Dose should be decreased 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. Concomitant use w/ medicinal products that are CYP3A substrates w/ narrow therapeutic ranges (eg, alfentanil, fentanyl, & quinidine); cyclosporine, tacrolimus, sirolimus; voriconazole; dabigatran; OATP1B1/3 substrates (eg, statins). Rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. Minor influence on the ability to drive or use machines. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Safety & efficacy in patients <18 yr have not been established.

Nausea, diarrhea, vomiting.

Possible subtherapeutic exposure w/ moderate (thioridazine, modafinil, ritonavir, lopinavir, efavirenz & etravirine) & strong (rifampicin, phenytoin, carbamazepine, St. John's wort, rifabutin & phenobarb) transporter &/or enzyme inducers. Decreased plasma conc w/ rifampicin. Increased plasma conc w/ OATP1B1/3 transporter inhibitors [eg, gemfibrozil, erythromycin, clarithromycin, & several PIs (atazanavir, simeprevir)]. Decreased plasma exposure & reduced efficacy of drugs eliminated through metabolism or 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 transporter 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 substrates of CYP2B6 (eg, bupropion), UGT1A1 (eg, raltegravir & dolutegravir), BRCP transporter (eg, rosuvastatin & sulfasalazine), OATP2B1 (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.

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