Genvoya
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
02-09-2022
Produktets egenskaber
(SPC)
02-09-2022
Offentlige vurderingsrapport
(PAR)
23-01-2018
Aktiv bestanddel:
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
Tilgængelig fra:
Gilead Sciences Ireland UC
ATC-kode:
J05AR
INN (International Name):
elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide
Terapeutisk gruppe:
Antivirals for systemic use,
Terapeutisk område:
HIV Infections
Terapeutiske indikationer:
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) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.,
Produkt oversigt:
Revision: 26
Autorisation status:
Authorised
Autorisation dato:
2015-11-19
Indlægsseddel
44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
GENVOYA 150 MG/150 MG/200 MG/10 MG FILM-COATED TABLETS
elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Genvoya is and what it is used for
2.
What you need to know before you take Genvoya
3.
How to take Genvoya
4.
Possible side effects
5.
How to store Genvoya
6.
Contents of the pack and other information
IF GENVOYA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
THE INFORMATION IN THIS LEAFLET
IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT GENVOYA IS AND WHAT IT IS USED FOR
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)
Genvoya is a single tablet for the
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION
in adults, adolescents and children 6 years of age and older, who
weigh at least 25 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE GENVOYA
DO NOT TAKE GENVOYA
•
IF YOU ARE ALLERGIC TO ELVITEGR
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Genvoya 150 mg/150 mg/200 mg/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 human immunodeficiency
virus-1 (HIV-1) infection without
any known mutations associated with resistance to the integrase
inhibitor class, emtricitabine or
tenofovir as follows:
•
In adults and adolescents aged from 12 years and with body weight at
least 35 kg
•
In children aged from 6 years and with body weight at least 25 kg for
whom alternative
regimens are unsuitable due to toxicities.
See sections 4.2, 4.4 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 paediatric patients aged 6 years and older, weighing at
least 25 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.
_Elderly_
No dose adjustment of Genvoya is required in elderly patients (see
sections 5.1 and 5.2).
3
_Renal impairment_
No dose
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