Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
Letermovir
MSD PHARMA (SINGAPORE) PTE. LTD.
J05AX18
INFUSION, SOLUTION CONCENTRATE
Letermovir 20mg/ml
INTRAVENOUS
Prescription Only
MSD International GmbH T/A MSD Ireland (Carlow)
ACTIVE
2019-07-30
CCDS-MK8228-MF-112022 PREVYMIS ™ FILM COATED TABLET 240 MG PREVYMIS ™ FILM COATED TABLET 480 MG PREVYMIS ™ CONCENTRATE FOR SOLUTION FOR INFUSION 20 MG/ML 1. INDICATIONS AND USAGE PREVYMIS is indicated for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-ser opositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). 2. DOSAGE AND ADMINISTRATION 2.1 GENERAL PREVYMIS Tablets • Administer with or without food. • Swallow tablets whole. Do not divide, cru sh or chew. PREVYMIS Concentrate for Solution for Infusion • PREVYMIS injection must be administered through a sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in -line filter. • Administer by intravenous infusion via a peripheral catheter or central venous line over approximately 60 minutes. • Do not administer as an intravenous bolus injection. PREVYMIS tablet and concentrate for solution for infusion may be used interchangeably at the discretion of the physician, and no dose adjustment is necessary. Missed Dose Instruct patients that if they miss a dose of PREVYMIS, they should take it as soon as they remember. If they do not remember until it is time for the next dose, instruct them to skip the missed dose and go back to the regular schedule. Instruct patients not to double their next dose or take more than the prescribed dose. 2.2 RECOMMENDED DOSAGE IN ADULTS The recommend ed dosage of PREVYMIS is 480 mg administered once daily. PREVYMIS should be started after HSCT. PREVYMIS may be started on the day of transplant and no later than 28 days post-transplant. PREVYMIS may be started before or after engraftment. Continue PREVY MIS through 100 days post-transplant. The safety and efficacy of letermovir use for more than 100 days has not been studied in c linical trials. 2.3 DOSAGE ADJUSTMENT IN ADULTS If PREVYMIS is co-administered with cyclosporine, the dosage of PREVYMIS should be decreased to 240 mg once daily [see Table 1 in 5 DRUG INTERACTIONS AND OTHER FORMS OF INTERACTIONS, 5.3 Estab Lees het volledige document