Short Prescribing Information PREVYMIS® (letermovir)

PREVYMIS^®: AI: letermovir. I (adults):prophylaxis of cytomegalovirus (CMV) infection or disease in CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT). D: 480 mg once daily; started no later than 28 days after HSCT; continued for up to a maximum of 200 days post-HSCT; use the solution for infusion only when oral therapy is impossible; dilute concentrate before administration and slowly administer the entire contents i.v. over 60 minutes; i.v. infusion only using a sterile 0,2 or 0,22 μm polyethersulfone (PES) inline filter; do not administer as a rapid infusion or bolus. For further indications and the corresponding dosages for adults, please refer to the prescribing information. CI: hypersensitivity to letermovir/excipients; concomitant administration with pimozide, ergot alkaloids, St. John’s wort (Hypericum perforatum) or ciclosporin in combination with dabigatran, atorvastatin, simvastatin, rosuvastatin, pitavastatin. Pr: The safety and efficacy of letermovir has been established in patients with a negative CMV DNA test result prior to initiation of prophylaxis. CMV DNA was monitored on a weekly basis until post-transplant Week 14, and subsequently bi-weekly until Week 24. Not recommended in moderate hepatic impairment combined with moderate or severe renal impairment, severe hepatic impairment (Child Pugh C), end-stage renal disease (CrCl <10 ml/min) or dialysis patients; under 18 years: safety and efficacy not established (no data). Risk of adverse reactions or reduced therapeutic effect due to medicinal product interactions. DDI: The combination of cyclosporine and letermovir may lead to more marked or additional effects on concomitant medicinal products as compared to letermovir alone. Co-administration of PREVYMIS^® with strong and moderate inducers of transporters (e.g. P-gp) and/or enzymes (e.g. UGTs) is not recommended, as it may lead to subtherapeutic letermovir exposure. Letermovir is an inhibitor of OATP1B1/3 transporters and may result in a clinically relevant increase in plasma concentrations of co-administered medicinal products that are OATP1B1/3 substrates. Co-administration of PREVYMIS^® with medicinal products that are inhibitors of OATP1B1/3 transporters may result in increased letermovir plasma concentrations. Letermovir is a moderate inducer of enzymes and transporters; Induction may give rise to reduced plasma concentrations of some metabolised and transported medicinal products. Letermovir is a moderate inhibitor of CYP3A: Coadministration of PREVYMIS^® may result in clinically relevant increases in the plasma concentrations of co-administered CYP3A substrates. Letermovir has the potential to decrease the exposure of CYP2C9 and/or CYP2C19 substrates potentially resulting in subtherapeutic levels. Letermovir is an inducer of intestinal P-gp: Administration of PREVYMIS^® may result in a clinically relevant decrease in plasma concentrations of co-administered medicinal products that are significantly transported by P-gp in the intestine. PREVYMIS^® should be used with caution when co-administered with medicinal products metabolised by CYP2B6, CYP2C8, UGT1A1 or transported by BCRP, OATP2B1 or by the renal transporter OAT3. P/L: pregnancy: not recommended; do not breastfeed. UDE: common: nausea, diarrhoea, vomiting. P: film-coated tablets: 28 tablets of 240 mg and 480 mg; vial: 240 mg/12 ml; 480 mg/24 ml. C: A. MAH: MSD Merck Sharp & Dohme AG, Werftestrasse 4, Lucerne, Switzerland; (V5.0); CH-CYT-00006.

Before prescribing please consult the full prescribing information published on the homepage of Swissmedic (www.swissmedicinfo.ch).