PREVYMIS FILM COATED TABLET 240MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Letermovir

Available from:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC code:

J05AX18

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Letermovir 240.0mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

MSD International GmbH T/A MSD Ireland (Ballydine)

Authorization status:

ACTIVE

Authorization date:

2019-07-30

Summary of Product characteristics

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