Tivicay 50mg Film-Coated Tablets

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Dolutegravir

Available from:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (International Name):

Dolutegravir

Units in package:

30tablet Tablets; 30tablet Tablets

Manufactured by:

GLAXO OPERATIONS UK LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
TIVICAY FILM-COATED TABLETS
Dolutegravir (50 mg)
WHAT IS IN THIS LEAFLET
1.
What Tivicay is used for
2.
How Tivicay works
3.
Before you use Tivicay
4.
How to use Tivicay
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Tivicay
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT TIVICAY IS USED FOR
Tivicay
contains
the
active
ingredient dolutegravir 50 mg (as
52.6
mg
dolutegravir
sodium)
which
is
an
antiretroviral
medicine known as an integrase
inhibitor
(which
inhibit
the
reproduction of retroviruses such
as HIV).
Tivicay is used for the treatment
of
human
immunodeficiency
virus
(HIV)
infection
in
combination
with
other
antiretroviral agents (inhibit the
reproduction of retroviruses) in
adults and children over 12 years
of age.
HOW TIVICAY WORKS
Tivicay
does
not
cure
HIV
infection; it reduces the amount
of virus in your body, and keeps
it at a low level. As a result of
that, it also increases the CD4
cell count in your blood. CD4
cells are a type of white blood
cells that are important in helping
your body to fight infection.
Not
everyone
responds
to
treatment
with
Tivicay
in
the
same
way.
Your
doctor
will
monitor the effectiveness of your
treatment.
Tivicay is always used in
combination with other anti-
retroviral medicines
(
_combination therapy_
). To
control your HIV infection, and
to stop your illness from getting
worse, you must keep taking all
your medicines, unless your
doctor tells you to stop taking
any.
BEFORE YOU USE TIVICAY
_When you must not use it _
Don’t use Tivicay
•
If
you
are
allergic
to
dolutegravir or any of the other
ingredients of this medicine.
•
In
combination
with
the
medicine
dofetilide
or
pilsicainide
(to
treat
heart
conditions),
or
fampridine
(also known as dalfampridine;
used in multiple sclerosis).
If you think this applies to you,
don’t use Tivicay until you have
checked with your doctor.
Tivicay should not be used in
children
and
adolescents
with
HIV infect

Summary of Product characteristics

CONFIDENTIAL
1
TIVICAY
DOLUTEGRAVIR
1.
NAME OF THE MEDICINAL PRODUCT
Tivicay 50 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dolutegravir sodium equivalent to 50
mg dolutegravir.
Yellow, round, biconvex tablets approximately 9 mm in diameter
debossed with ‘SV 572’ on one side
and ‘50’ on the other side.
For the full list of excipients, see section 5.1.
3.
CLINICAL INFORMATION
3.1
THERAPEUTIC INDICATIONS
Tivicay is indicated in combination with other anti-retroviral
medicinal products for the treatment of
Human Immunodeficiency Virus (HIV) infected adults and adolescents
above 12 years of age.
3.2
POSOLOGY AND METHOD OF ADMINISTRATION
Pharmaceutical form:
Film-coated tablets.
Tivicay should be prescribed by physicians experienced in the
management of HIV infection.
_ _
Posology
_Adults _
_ _
_Patients infected with HIV-1 without documented or clinically
suspected resistance to the integrase class _
The recommended dose of dolutegravir is 50 mg orally once daily.
Tivicay should be administered twice daily in this population when
co-administered with some
medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or
rifampicin). Please refer to section 3.5.
_Patients infected with HIV-1 with resistance to the integrase class
(documented or clinically suspected) _
The recommended dose of dolutegravir is 50 mg twice daily.
In the presence of documented resistance that includes Q148 +
≥
2 secondary mutations from
G140A/C/S, E138A/K/T, L74I, modelling suggests that an increased dose
may be considered for
patients with limited treatment options (less than 2 active agents)
due to advanced multi class resistance
(see section 4.2).
The decision to use dolutegravir for such patients should be informed
by the integrase resistance pattern
(see section 4.1).
_Adolescents aged 12 and above _
In adolescents (12 to less than 18 years of age and weighing at least
40 kg) infected with HIV-1 without
resistance to the integrase class, the recommended dose of
dolutegrav