Genvoya (Elvitegravir 150mgCobicistat 150mgEmtricitabine 200mgTenofovir alafenamide10mg) Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

EMTRICITABINE; Tenofovir alafenamide fumarate; Elvitegravir; Cobicistat on silicon dioxide

Boleh didapati daripada:

Gilead Sciences Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

EMTRICITABINE; Tenofovir alafenamide fumarate; Elvitegravir; Cobicistat on silicon dioxide

Unit dalam pakej:

30tablet Tablets

Dikeluarkan oleh:

PATHEON INC

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
GENVOYA
® FILM-COATED TABLETS
ELVITEGRAVIR 150MG/COBICISTAT 150MG/EMTRICITABINE 200MG/TENOFOVIR
ALAFENAMIDE 10MG
1
WHAT IS IN THIS LEAFLET
1.
What Genvoya is used for
2.
How Genvoya works
3.
Before you use Genvoya
4.
How to use Genvoya
5.
While you are using
Genvoya
6.
Side effects
7.
Storage and disposal of
Genvoya
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT GENVOYA IS USED FOR
Genvoya is a single tablet for
the
TREATMENT OF HUMAN
IMMUNODEFICIENCY VIRUS 1
(HIV-1) INFECTION
in adults and
adolescents 12 years of age and
older, who weigh at least 35 kg.
Genvoya reduces the amount of
HIV in your body. This will
improve your immune system
and reduce the risk of
developing illnesses linked to
HIV infection.
HOW GENVOYA WORKS
Genvoya contains four active
substances:
•
ELVITEGRAVIR,
an
antiretroviral
medicine known as an
integrase inhibitor
•
COBICISTAT,
a booster
(enhancer) of the effects of
elvitegravir
•
EMTRICITABINE,
an
antiretroviral medicine known
as a nucleoside reverse
transcriptase inhibitor (NRTI)
•
TENOFOVIR ALAFENAMIDE,
an
antiretroviral medicine known
as a nucleotide reverse
transcriptase inhibitor (NtRTI)
BEFORE YOU USE GENVOYA
_When you must not use it_
DO NOT TAKE GENVOYA
•
IF YOU ARE ALLERGIC TO
ELVITEGRAVIR, COBICISTAT,
EMTRICITABINE, TENOFOVIR
ALAFENAMIDE
or any of the
other ingredients of this
medicine (listed in ingredient
section of this leaflet).
•
IF YOU ARE TAKING ONE OF
THESE MEDICINES:
-
ALFUZOSIN
(used to treat
an
enlarged prostate gland)
-
DABIGATRAN
(used to
prevent and treat blood
clots)
-
AMIODARONE, QUINIDINE
(used to correct irregular
heartbeats)
-
CARBAMAZEPINE,
PHENOBARBITAL, PHENYTOIN
(used to
prevent seizures)
-
RIFAMPICIN
(used to
prevent
and treat tuberculosis and
other infections)
-
DIHYDROERGOTAMINE,
ERGOMETRINE, ERGOTAMINE
(used to treat
migraine
headache)
-
CISAPRIDE
(used to relieve
certain stomach problems)
-
ST. JOHN’S WORT
(
_Hypericum perforatum_
, a
herb

Ciri produk

1
GENVOYA
®
(elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) For Oral
Use
Rx Only
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200
mg/tenofovir alafenamide 10 mg)
Film-Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200
mg of emtricitabine and
tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir
alafenamide.
Excipients with known effect
Each tablet contains 58 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Green, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5
mm, debossed with “GSI” on
one side of the tablet and “510” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Genvoya is indicated for the treatment of adults and adolescents (aged
12 years and older with body
weight at least 35 kg) infected with human immunodeficiency virus-1
(HIV-1) infection without any
known mutations associated with resistance to the integrase inhibitor
class, emtricitabine or tenofovir
(see sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Adults and adolescents aged 12 years and older, weighing at least 35
kg_
_ _
One tablet to be taken once daily with food.
If the patient misses a dose of Genvoya within 18 hours of the time it
is usually taken, the patient
should take Genvoya with food as soon as possible and resume the
normal dosing schedule. If a
patient misses a dose of Genvoya by more than 18 hours, the patient
should not take the missed dose
and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking Genvoya another tablet
should be taken.
2
_Elderly_
No dose adjustment of Genvoya is required in elderly patients (see
sections 5.1 and 5.2).
_Renal impairment_
No dose ad