PREZCOBIX darunavir/cobicistat 800 mg/150 mg film coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

darunavir, Quantity: 800 mg; cobicistat, Quantity: 150 mg

Available from:

Janssen-Cilag Pty Ltd

INN (International Name):

Cobicistat,Darunavir

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: microcrystalline cellulose; crospovidone; silicon dioxide; magnesium stearate; hypromellose; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

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-naive patients,- Antiretroviral treatment-experienced patients with no darunavir resistance associated mutations and who have plasma HIV-1 RNA <100,000 copies/mL,- Antiretroviral treatment-experienced but HIV protease inhibitor-naive patients for whom HIV-1 genotype testing is unavailable (see section 4.2 Dose and method of administration)

Product summary:

Visual Identification: Pink oval-shaped tablet, debossed with "800" on one side and "TG" on the opposite side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2015-09-24

Patient Information leaflet

PREZCOBIX (211103) ACMI
1
PREZCOBIX
® TABLETS
_Darunavir/cobicistat _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE
This leaflet answers some common
questions about PREZCOBIX
tablets. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
PREZCOBIX against the benefits
this medicine is expected to have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN PREZCOBIX ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING PREZCOBIX.
You may need to read it again.
WHAT PREZCOBIX IS
USED FOR
PREZCOBIX is used to treat adults,
who are infected by HIV (Human
Immunodeficiency Virus).
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.
PREZCOBIX can be taken with
other anti-HIV medicines. Your
doctor will discuss with you which
combination of medicines will work
best with PREZCOBIX.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PREZCOBIX
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
PREZCOBIX
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE PREZCOBIX:
•
if you are allergic
(hypersensitive) to darunavir,
cobicistat or any of the other
ingredients of PREZCOBIX.
Symptoms of an allergic reaction
may include rash, itching or hives
on the skin, shortness of breath,
wheezing o

Summary of Product characteristics

CCDS210601
1
PREZCOBIX (211021) API
AUSTRALIAN PRODUCT INFORMATION
PREZCOBIX
®
DARUNAVIR/COBICISTAT
FILM-COATED TABLETS
1. NAME OF THE MEDICINE
Darunavir/cobicistat
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-naive patients
-
Antiretroviral treatment-experienced patients with no darunavir
resistance associated
mutations and who have plasma HIV-1 RNA <100,000 copies/mL
-
Antiretroviral treatment-experienced but HIV protease inhibitor-naive
patients for whom
HIV-1 genotype testing is unavailable (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.
Product Information - Australia
CCDS210601
2
PREZCOBIX (211021) API
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
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