PREVYMIS 480 MG FILM-COATED TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LETERMOVIR

Available from:

MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL

ATC code:

J05AX18

Pharmaceutical form:

FILM COATED TABLETS

Composition:

LETERMOVIR 480 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

MERCK SHARP & DOHME LLC, USA

Therapeutic area:

LETERMOVIR

Therapeutic indications:

PREVYMIS is indicated for prophylaxis of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).Consideration should be given to official guidance on the appropriate use of antiviral agents.

Authorization date:

2020-12-03

Patient Information leaflet

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS
REGULATIONS (PREPARATIONS) - 1986
This medicine is marketed upon physician’s prescription only
PREVYMIS
® 240 MG FILM-
COATED TABLETS
PREVYMIS
® 480 MG FILM-
COATED TABLETS
Each film-
coated tablet
of
PREVYMIS 240 MG
contains:
letermovir 240 mg
Each film-
coated tablet of
PREVYMIS 480 MG
contains:
letermovir 480 mg
For the list of the inactive ingredients see section 6
.
“FURTHER INFORMATION”. See also
subsection 2.
“Important information about some of the ingredients of the
medicine”
.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THE
MEDICINE.
•
This leaflet contains concise
information
about the medicine. If you have any further
questions, refer to the doctor or pharmacist.
•
This medicine has been prescribed for you
.
Do not pass it on to others. It may harm them,
even if their medical condition seems similar to yours
.
1.
WHAT PREVYMIS IS INTENDED FOR?
PREVYMIS
is indicated for
prophylaxis of cytomegalovirus (CMV) reactivation and disease in
adult CMV-
seropositive recipients [R+] of an allogeneic haematopoietic stem cell
transplant
(HSCT).
THERAPEUTIC GROUP:
Antivirals for
systemic use, direct acting antivirals, ATC code: J05AX18
.
PREVYMIS
is an antiviral medicine that contains the active substance
letermovir.
The
medicine is
given
upon physician’s prescription only
.
PREVYMIS
is a medicine for adults who have recently had a bone marrow
transplant. The
medicine
helps stop you from getting ill from CMV (‘cytomegalovirus’)
.
CMV is a virus that a lot of people have without knowing. Normally,
CMV just stays in their
body and it do
es not hurt them.
However, if your immune system is weak after you get a
bone marrow transplant, you may be at high risk of becoming ill from
CMV
.
2.
BEFORE USING PREVYMIS
DO NOT USE
PREVYMIS IF:
•
you are allergic to letermovir or any of the other ingredients of this
medicine (listed in
section 6).
•
you take either of these medicines:
o
pimozide -
antipsychotic
o
ergot alkaloids (suc

Summary of Product characteristics

1
1.
NAME OF
THE
MEDICINAL PRODUCT
PREVYMIS
®
240 mg film-
coated tablets
PREVYMIS
®
480 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PREVYMIS
240 mg film-
coated tablets
Each film-
coated tablet contains 240
mg of letermovir.
PREVYMIS
480 mg film-
coated tablets
Each film-
coated tablet contains 480
mg of letermovir.
Excipients with known effect
Each 240 mg film-
coated tablet contains 4
mg of lactose (as monohydrate).
Each 480 mg film-
coated tablet contains
6.4
mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet (tablet)
PREVYMIS
240 mg film-
coated tablets
Yellow oval tablet of dimensions 16.5
mm x 8.5 mm,
debossed with “591” on one side and
corporate
logo on the other side.
PREVYMIS
480 mg film-
coated tablets
Pink oval, bi
-
convex tablet of dimensions 21.2
mm x 10.3
mm, debossed with “595” on one side and
corporate
logo on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PREVYMIS
is indicated for
prophylaxis of
cytomegalovirus (CMV) reactivation and disease in adult
CMV-
seropositive recipients [R+] of an allogeneic haematopoietic stem cell
transplant (HSCT).
Consideration should be given to official guidance on the appropriate
use of antiviral agents.
4.2
POSOL
OGY AND METHOD OF ADMINISTRATION
PREVYMIS
should be initiated by a physician experienced in the management of
patients who have
had a
n allogeneic
haematopoietic stem cell transplant.
Posology
The recommended dose of
PREVYMIS
is one 480
mg tablet 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. Prophylaxis
with
PREVYMIS
should cont
inue through 100 days post
-transplant.
The safety and efficacy of letermovir use for more
than 100 days has not been studied in clinical
trials.
Prolonged letermovir prophylaxis beyond 100 days post
-
transplant may be of benefit in some
2
patients at