Symtuza

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

darunavir, cobicistat, emtricitabine, tenofovir alafenamide

Available from:

Janssen-Cilag International NV

ATC code:

J05

INN (International Name):

darunavir, cobicistat, emtricitabine, tenofovir alafenamide

Therapeutic group:

Antivirals for systemic use, Antivirals for treatment of HIV infections, combinations

Therapeutic area:

HIV Infections

Therapeutic indications:

Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).Genotypic testing should guide the use of Symtuza.

Product summary:

Revision: 17

Authorization status:

Authorised

Authorization date:

2017-09-21

Patient Information leaflet

42
B.
PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYMTUZA 800 MG/150 MG/200 MG/10 MG - FILM-COATED TABLETS
darunavir/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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Symtuza is and what it is used for
2.
What you need to know before you take Symtuza
3.
How to take Symtuza
4.
Possible side effects
5.
How to store Symtuza
6.
Contents of the pack and other information
1.
WHAT SYMTUZA IS AND WHAT IT IS USED FOR
Symtuza is an antiretroviral medicine used to treat infection with
human immunodeficiency virus 1
(HIV-1). It is used in adults and adolescents aged 12 years and older
who weigh at least 40 kg.
Symtuza contains four active substances:

darunavir, an anti-HIV medicine known as a protease inhibitor

cobicistat, a booster (enhancer) of darunavir

emtricitabine, an anti-HIV medicine known as a nucleoside reverse
transcriptase inhibitor

tenofovir alafenamide, an anti-HIV medicine known as a nucleotide
reverse transcriptase
inhibitor
Symtuza reduces HIV-1 in your body and this will improve your immune
system (your body’s natural
defences) and reduce the risk of developing illnesses linked to HIV
infection but Symtuza is not a cure
for HIV infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SYMTUZA
DO NOT TAKE SYMTUZA
-
if you are ALLERGIC (hypersensitive) to darunavir, cobicistat,
emtricitabine, tenofovir
alafenamide, or any of the other ingredients of Symtuza (listed in
section 6).
-
if you have SEVERE LIVE

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Symtuza 800 mg/150 mg/200 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg of darunavir (as ethanolate),
150 mg of cobicistat, 200 mg of
emtricitabine, and 10 mg of tenofovir alafenamide (as fumarate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow to yellowish-brown capsule shaped tablet of 22 mm x 11 mm,
debossed with “8121” on one
side and “JG” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symtuza is indicated for the treatment of human immunodeficiency virus
type 1 (HIV-1) infection in
adults and adolescents (aged 12 years and older with body weight at
least 40 kg).
Genotypic testing should guide the use of Symtuza (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-1 infection.
Posology
The recommended dose regimen in adults and adolescents aged 12 years
and older, weighing at least
40 kg, is one tablet taken once daily with food.
_Antiretroviral Therapy (ART)-naïve patients_
The recommended dose regimen is one film-coated tablet of Symtuza once
daily taken with food.
_ART-experienced patients_
One film-coated tablet of Symtuza once daily taken with food may be
used in patients with prior
exposure to antiretroviral medicinal products but without darunavir
resistance associated mutations
(DRV-RAMs)* and who have plasma HIV-1 RNA < 100 000 copies/mL and CD4+
cell count
≥ 100 cells x 10
6
/L (see section 5.1).
*
DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V,
L89V.
_Advice on missed doses_
If a dose of Symtuza is missed within 12 hours of the time it is
usually taken, patients should be
instructed to take the prescribed dose of Symtuza with food as soon as
possible. If a missed dose is
noticed later than 12 hours of the time it is usually taken, it s