Prezcobix® (darunavircobicistat) 800mg150mg Film-Coated Tablet

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DARUNAVIR ETHANOLATE; Cobicistat on silicon dioxide

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

DARUNAVIR ETHANOLATE; Cobicistat on silicon dioxide

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Janssen Ortho LLC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PREZCOBIX
® (DARUNAVIR/COBICISTAT)
800MG/150MG FILM-COATED TABLETS
Darunavir/Cobicistat (800mg/150mg)
1
WHAT IS IN THIS LEAFLET
1.
What PREZCOBIX
®
is used for
2.
How PREZCOBIX
®
works
3.
Before you use PREZCOBIX
®
4.
How to use PREZCOBIX
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
PREZCOBIX
®
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT PREZCOBIX
® IS USED FOR
PREZCOBIX
®
is used to treat adults
infected by HIV-1 (Human
Immunodeficiency Virus-1), who may or
may not have received prior treatment.
PREZCOBIX
®
should be taken with other
anti-HIV medicines. Your doctor will
discuss with you which combination of
medicines will work best with
PREZCOBIX
®
.
HOW PREZCOBIX
®
WORKS
PREZCOBIX
®
contains two active
ingredients which work in combination for
the treatment of HIV. These active
ingredients are darunavir and cobicistat.
Darunavir is an antiretroviral medicine. It
belongs to a group of medicines called
protease inhibitors. Darunavir works by
reducing the amount of HIV in your body.
Reducing the amount of HIV in your
blood improves your immune system, and
reduces the risk of developing illnesses as
a result of HIV infection.
Cobicistat is a type of medicine called a
pharmacokinetic enhancer (or "booster").
Cobicistat helps increase the levels of
darunavir, the HIV medicine in your body.
BEFORE YOU USE PREZCOBIX
®
It is important to tell your doctor if you are
taking corticosteroids such as
betamethasone, budesonide, fluticasone,
mometasone, prednisone and
triamcinolone. These medicines are used
to treat allergies, asthma, inflammatory
bowel diseases, inflammatory conditions
of the eyes, joints and muscles and other
inflammatory conditions. If alternatives
cannot be used, its use should only take
place after medical evaluation and under
close monitoring by your doctor for
corticosteroid side effects.
-
_When you must not use it _
Do not take PREZCOBIX
®
•
if you are aller

Ciri produk

1
1. NAME OF THE MEDICINE
PREZCOBIX
®
(darunavir/cobicistat) 800 mg/150 mg Film-Coated Tablet
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PREZCOBIX 800/150 mg tablets contain 800 mg of darunavir (as 867.28 mg
darunavir ethanolate) and
150 mg of cobicistat.
For a full list of excipients, see
SECTION 6.1
List of excipients.
3. PHARMACEUTICAL FORM
PREZCOBIX 800/150 mg film-coated tablet: Pink oval-shaped tablet,
debossed with “800” on one side
and “TG” on the opposite side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PREZCOBIX, a fixed dose combination of darunavir and cobicistat, is
indicated in combination with
other antiretroviral agents for the treatment of adult patients with
human immunodeficiency virus-1
(HIV-1) infection in:
-
Antiretroviral treatment-naïve patients
-
Antiretroviral treatment-experienced patients with no darunavir
resistance associated mutations
and who have plasma HIV-1 RNA <100,000 copies/mL and CD4+ cell count
≥ 100 cells x
10
6
/L
-
Antiretroviral treatment-experienced but HIV protease inhibitor-naive
patients for whom HIV-
1 genotype testing is unavailable and who have plasma HIV-1 RNA <
100,000 copies/mL and
CD4+ cell count ≥ 100 cells x 10
6
/L (see
SECTION 4.2
Dose and method of administration)
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE IN ADULTS
The recommended dose regimen is PREZCOBIX one tablet taken once daily
with food. The type of
food does not affect the exposure to PREZCOBIX.
For antiretroviral treatment-experienced patients* HIV-1 genotype
testing is recommended.
*Darunavir resistance associated mutations: V11l, V32l, L33F, I47V,
I50V, I54M, I54L, T74P, L76V,
I84V, L89V.
When HIV genotypic testing is not feasible:
•
PREZISTA (darunavir) should be used for protease inhibitor-experienced
patients. Refer to
PREZISTA Product Information for dosing recommendations.
•
PREZCOBIX can be used in protease inhibitor naïve patients
DOSE IN PAEDIATRIC PATIENTS (17 YEARS OF AGE AND YOUNGER)
The safety and efficacy of PREZCOBIX have not been established in
paedi