Delstrigo

Pajjiż: Unjoni Ewropea

Lingwa: Ingliż

Sors: EMA (European Medicines Agency)

Ingredjent attiv:

doravirine, lamivudine, tenofovir disoproxil fumarate

Disponibbli minn:

Merck Sharp & Dohme B.V.

Kodiċi ATC:

J05AR

INN (Isem Internazzjonali):

doravirine, lamivudine, tenofovir disoproxil

Grupp terapewtiku:

Antivirals for treatment of HIV infections, combinations

Żona terapewtika:

HIV Infections

Indikazzjonijiet terapewtiċi:

Delstrigo is indicated for the treatment of adults infected with HIV 1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir.Delstrigo is also indicated for the treatment of adolescents aged 12 years and older weighing at least 35 kg who are infected with HIV-1 without past or present evidence of resistance to the NNRTI class, lamivudine, or tenofovir and who have experienced toxicities which preclude the use of other regimens that do not contain tenofovir disoproxil.

Sommarju tal-prodott:

Revision: 11

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2018-11-22

Fuljett ta 'informazzjoni

42
B. PACKAGE LEAFLET
43
PACKAGE LEAFLET: INFORMATION FOR THE USER
DELSTRIGO 100 MG/300 MG/245 MG FILM-
COATED TABLETS
doravirine/ lamivudine/
tenofovir disoproxil
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 a
gain.
•
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,
e
ven 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 Delstrigo is and
what it is used for
2.
What you need to know before you take
Delstrigo
3.
How to take
Delstrigo
4.
Possible side effects
5.
How to store
Delstrigo
6.
Contents of the pack and other information
1.
WHAT
DELSTRIGO
IS AND WHAT IT IS USED FOR
WHAT DELSTRIGO IS
Delstrigo
is used to treat
HIV (‘human immunodeficiency virus’) infection. It belongs to a
group of
medicines called ‘antiretroviral medicines’.
Delstrigo
contains the active substances:
•
Doravirine - a non-
nucleoside reverse transcriptase inhibitor (NNRTI)
•
Lamivudine
- a
nucleoside analogue reverse transcriptase inhibitor (NRTI)
•
Tenofovir disoproxil
-
a nucleoside analogue reverse transcriptase inhibitor (NRTI)
WHAT DELSTRIGO IS USED FOR
Delstrigo
is used to treat HIV
infection in adults, and
adolescents
aged 12
years and older
weighing at
least 35 kg
. HIV is the virus that causes AIDS (‘
acquired immune deficiency s
yndrome’).
You should
not take Delstrigo
if your doctor
has
told you that
the virus
causing your infection
is resistant to any of
the medicines in
Delstrigo.
HOW DELSTRIGO WORKS
Delstrigo works by
preventing HIV
from making more viruses in your body. This will help by
:
•
reducing the amount of HIV in your blood (th
is is called your ‘viral load’)
�

Karatteristiċi tal-prodott

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Delstrigo 100 mg/300 mg/245 mg film-
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-
coated tablet
contains 100
mg of doravirine, 300
mg of lamivudine
(3TC), and 245 mg of
tenofovir disoproxil
as
tenofovir disoproxil fumarate
(TDF).
Excipient with known effect
Each film-
coated tablet contains
8.6 mg lactose (as
monohydrate
).
For the full list of
excipients, see section
6.1.
3.
PHARMACEUTICAL
FORM
Film-
coated tablet
(tablet).
Yellow, oval
-shaped,
tablet of dimensions 21.59
mm x 11.30 mm,
debossed with the corporate
logo
and 776 on
one side and plain on the other side.
4.
C
LINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Delstrigo
is indicated
for the treatment of adult
s
infected with
human i
mmunodeficiency
virus type 1
(HIV-1) without past or present evidence of
resistance to
the non-
nucleoside reverse transcriptase
inhibitors (NNRTI) class,
lamivudine, or tenofovir
(see section
s 4.4 and 5.1).
Delstrigo is also indicated for the treatment of adolescents aged 12
years and older weighing at least
35 kg who are
infected with HIV
-
1 without past or present evidence of resistance to the NNRTI class,
lamivudine, or tenofovir and who have experienced toxicities which
preclude the use of other
regimens that do not contain tenofovir disoproxil (see sections
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
The recommended dose of
Delstrigo is one
100/300/245
mg
tablet taken orally
once daily with or
without food
.
Dose adjustmen
t
If Delstrigo is co-
administered with rifabutin,
the doravirine dose should be increased to
100 mg twice
daily. This is achieved by adding
one 100 mg tablet of doravirine (as a
single agent)
, to be taken
approximately 12 hours
apart from the dose of
Delstrigo (see section 4.5).
Co-
administration of
doravirine with
other moderate
CYP3A inducers
has not been evaluated
, but
decreased