Livtencity

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

Maribavir

Tilgængelig fra:

Takeda Pharmaceuticals International AG Ireland Branch

ATC-kode:

J05AX10

INN (International Name):

maribavir

Terapeutisk gruppe:

Antivirals for systemic use

Terapeutisk område:

Cytomegalovirus Infections

Terapeutiske indikationer:

LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).Consideration should be given to official guidance on the appropriate use of antiviral agents.

Produkt oversigt:

Revision: 4

Autorisation status:

Authorised

Autorisation dato:

2022-11-09

Indlægsseddel

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LIVTENCITY 200 MG FILM-COATED TABLETS
maribavir
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What LIVTENCITY is and what it is used for
2.
What you need to know before you take LIVTENCITY
3.
How to take LIVTENCITY
4.
Possible side effects
5.
How to store LIVTENCITY
6.
Contents of the pack and other information
1.
WHAT LIVTENCITY IS AND WHAT IT IS USED FOR
LIVTENCITY is an antiviral medicine that contains the active substance
maribavir.
It is a medicine used to treat adults who have had an organ or bone
marrow transplant and developed a
CMV (‘cytomegalovirus’) infection that did not go away or came
back again after taking another
antiviral medicine.
CMV is a virus that a lot of people have without symptoms and normally
just stays in the body
without causing any harm. However, if your immune system is weakened
after you get an organ or
bone marrow transplant, you may be at higher risk of becoming ill from
CMV.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIVTENCITY
DO NOT TAKE LIVTENCITY

if you are allergic to the active substance or any of the other
ingredients of this medicine (listed in
section 6).

if you take either of these medicines:
o
ganciclovir (used to manage CMV infection)
o

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
LIVTENCITY 200 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg maribavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue, oval shaped convex tablet of 15.5 mm, debossed with “SHP” on
one side and “620” on the other
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV)
infection and/or disease that
are refractory (with or without resistance) to one or more prior
therapies, including ganciclovir,
valganciclovir, cidofovir or foscarnet in adult patients who have
undergone a haematopoietic stem cell
transplant (HSCT) or solid organ transplant (SOT).
Consideration should be given to official guidance on the appropriate
use of antiviral agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
LIVTENCITY should be initiated by a physician experienced in the
management of patients who have
undergone solid organ transplant or haematopoietic stem cell
transplant.
Posology
The recommended dose of LIVTENCITY is 400 mg (two 200 mg tablets)
twice daily resulting in a
daily dose of 800 mg for 8 weeks. Treatment duration may need to be
individualised based on the
clinical characteristics of each patient.
3
Co-administration with CYP3A inducers
Co-administration of LIVTENCITY with the strong cytochrome P450 3A
(CYP3A) inducers
rifampicin, rifabutin or St. John’s wort is not recommended due to
potential for a decrease in efficacy
of maribavir.
If co-administration of LIVTENCITY with other strong or moderate CYP3A
inducers (e,g.,
carbamazepine, efavirenz, phenobarbital and phenytoin) cannot be
avoided, the LIVTENCITY dose
should be i