BIKTARVY

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

BICTEGRAVIR AS SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE AS FUMARATE

Saatavilla:

GILEAD SCIENCES ISRAEL LTD

ATC-koodi:

J05AR20

Lääkemuoto:

FILM COATED TABLETS

Koostumus:

TENOFOVIR ALAFENAMIDE AS FUMARATE 25 MG; EMTRICITABINE 200 MG; BICTEGRAVIR AS SODIUM 50 MG

Antoreitti:

PER OS

Prescription tyyppi:

Required

Valmistaja:

GILEAD SCIENCES IRELAND UC, IRELAND

Terapeuttinen alue:

EMTRICITABINE, TENOFOVIR ALAFENAMIDE AND BICTEGRAVIR

Käyttöaiheet:

Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus 1 (HIV 1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.

Valtuutus päivämäärä:

2019-02-14

Pakkausseloste

1
Patient leaflet in accordance with the Pharmacists’ (Products)
Regulations - 1986
This medicine is to be supplied by doctor’s prescription only
Biktarvy
®
Film-coated tablets
Active ingredients: Each tablet contains –
Bictegravir (as sodium)
50 mg
emtricitabine
200 mg
tenofovir alafenamide (as fumarate)
25 mg
Inactive and allergenic substances: see section 6 _“Additional
information_”.
Read all of this leaflet carefully before you start taking this
medicine because it
contains important information for you. This leaflet contains
essential information about
this medicine. If you have any further questions, ask your doctor or
pharmacist. Keep this
leaflet. You may need to read it again. This medicine has been
prescribed for you only. Do
not pass it on to others. It may harm them, even if it seems to you
that their illness issimilar to
yours. If you experience any side effects, talk to your doctor or
pharmacist. Even if you
experience any side effects that are not listed in this leaflet (see
section 4).
This medicine is intended for adults aged 18 years and over.
1.
What is the medicine intended for
Biktarvy is indicated for the treatment of human immunodeficiency
virus 1 (HIV-1) infection in
adults without present or past evidence of viral resistance to the
integrase inhibitor class,
emtricitabine or tenofovir.
Therapeutic group: Antiviral for systemic use; antivirals for
treatment of HIV infections,
combinations.
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.
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)
2.
Before taking the medicine
.
X
.
Do not take this medicine
•
If y

Valmisteyhteenveto

1
BIKTARVY
®
(Bictegravir/emtricitabine/tenofovir alafenamide fumarate)
Film-coated tablets
1.
NAME OF THE MEDICINAL PRODUCT
Biktarvy
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
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 adults infected with human
immunodeficiency virus-1
(HIV-1) 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
One tablet to be taken once daily.
_Missed doses _
If the patient misses a dose of Biktarvy within 18 hours of the time
it is usually taken, the patient
should take Biktarvy as soon as possible and resume the normal dosing
schedule. If a patient misses a
dose of Biktarvy 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 Biktarvy another tablet
should be taken. If a patient
vomits more than 1 hour after taking Biktarvy they do not need to take
another dose of Biktarvy until
the next regularly scheduled dose.
_Special populations _
_ _
_Elderly_
2
No dose adjustment of Biktarvy is required in patients aged ≥ 65
years (see sections 4.8 and 5.2).
_ _
_Hepatic impairment _
No dose adjustment of Biktarvy is required in patients with mild
(Child-Pugh Class A) or moderate
(Child-Pugh Class B) hepatic impairment. Biktarvy has not been studied
i