Biktarvy

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

bictegravir, emtricitabine, tenofovir alafenamide, fumarate

Tilgjengelig fra:

Gilead Sciences Ireland UC

ATC-kode:

J05AR20

INN (International Name):

bictegravir, emtricitabine, tenofovir alafenamide

Terapeutisk gruppe:

Antivirals for systemic use

Terapeutisk område:

HIV Infections

Indikasjoner:

Biktarvy is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection in adults and paediatric patients at least 2 years of age and weighing at least 14 kg i without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.(see section 5.1)

Produkt oppsummering:

Revision: 16

Autorisasjon status:

Authorised

Autorisasjon dato:

2018-06-21

Informasjon til brukeren

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIKTARVY 30 MG/120 MG/15 MG FILM-COATED TABLETS
bictegravir/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.
IF BIKTARVY 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”).
WHAT IS IN THIS LEAFLET
1.
What Biktarvy is and what it is used for
2.
What you need to know before you take Biktarvy
3.
How to take Biktarvy
4.
Possible side effects
5.
How to store Biktarvy
6.
Contents of the pack and other information
1.
WHAT BIKTARVY IS AND WHAT IT IS USED FOR
Biktarvy contains three active substances:
•
BICTEGRAVIR,
an antiretroviral medicine known as an integrase
strand transfer inhibitor (INSTI)
•
EMTRICITABINE,
an antiretroviral medicine of a type known as a nucleoside reverse
transcriptase
inhibitor (NRTI)
•
TENOFOVIR ALAFENAMIDE,
an antiretroviral medicine of a type known as a nucleotide reverse
transcriptase inhibitor (NtRTI)
Biktarvy is a single tablet for the treatment of human
immunodeficiency virus 1 (HIV-1) infection in
adults, adolescents and children 2 years of age and older, who weigh
at least 14 kg.
Biktarvy 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 BIKTARVY
DO NOT TAKE BIKTARVY
•
IF YOU ARE ALLERGIC TO BICTEGRAVIR, EMTRICITABINE, TENOFOVIR
AL

Preparatomtale

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Biktarvy 30 mg/120 mg/15 mg film-coated tablets
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Biktarvy 30 mg/120 mg/15 mg film-coated tablets
Each film-coated tablet contains bictegravir sodium equivalent to 30
mg of bictegravir, 120 mg of
emtricitabine, and tenofovir alafenamide fumarate equivalent to 15 mg
of tenofovir alafenamide.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Each film-coated tablet contains bictegravir sodium equivalent to 50
mg of bictegravir, 200 mg of
emtricitabine, and tenofovir alafenamide fumarate equivalent to 25 mg
of tenofovir alafenamide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Biktarvy 30 mg/120 mg/15 mg film-coated tablets
Pink, capsule-shaped, film-coated tablet, debossed with “BVY” on
one side and a score line on the
other side of the tablet. Each tablet is approximately 14 mm x 6 mm.
The score line is only to
facilitate breaking for ease of swallowing and not to divide into
equal doses.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Purplish-brown, capsule-shaped, film-coated tablet debossed with
“GSI” on one side and “9883” on
the other side of the tablet. Each tablet is approximately 15 mm

8 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Biktarvy is indicated for the treatment of human immunodeficiency
virus-1 (HIV-1) infection in adults
and paediatric patients at least 2 years of age and weighing at least
14 kg without present or past
evidence of viral resistance to the integrase inhibitor class,
emtricitabine or tenofovir (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_Paediatric patients at least 2 years of age and weighing at least 14_
_kg to less than 25 kg _
One 30 mg/120 mg/15 mg tablet to be taken once daily.
_Adults and paediatric patients wei