Descovy

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

emtricitabine, tenofovir alafenamide

Διαθέσιμο από:

Gilead Sciences Ireland UC

Φαρμακολογική κατηγορία (ATC):

J05AR17

INN (Διεθνής Όνομα):

emtricitabine, tenofovir alafenamide

Θεραπευτική ομάδα:

Antivirals for systemic use

Θεραπευτική περιοχή:

HIV Infections

Θεραπευτικές ενδείξεις:

Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).

Περίληψη προϊόντος:

Revision: 20

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2016-04-21

Φύλλο οδηγιών χρήσης

62
B. PACKAGE LEAFLET
63
PACKAGE LEAFLET: INFORMATION FOR THE USER
DESCOVY 200 MG/10 MG FILM-COATED TABLETS
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 Descovy is and what it is used for
2.
What you need to know before you take Descovy
3.
How to take Descovy
4.
Possible side effects
5.
How to store Descovy
6.
Contents of the pack and other information
1.
WHAT DESCOVY IS AND WHAT IT IS USED FOR
Descovy contains two active substances:
•
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)
Descovy blocks the action of the reverse transcriptase enzyme, which
is essential for the virus to
multiply. Descovy, therefore, reduces the amount of HIV in your body.
Descovy in combination with other medicines is for the
TREATMENT OF HUMAN IMMUNODEFICIENCY
VIRUS 1 (HIV-1) INFECTION
in adults and adolescents 12 years of age and older, who weigh at
least
35 kg.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESCOVY
DO NOT TAKE DESCOVY
•
IF YOU ARE ALLERGIC TO EMTRICITABINE, TENOFOVIR ALAFENAMIDE
or any of the other ingredients of
this medicine (listed in section 6 of this leaflet).
WARNINGS AND PRECAUTIONS
You must remain under the care of your doctor while taking Descovy.
This medicine is not a cure for HIV infection. While taking Descovy
you may still develop infections
or other illnesses a

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Descovy 200 mg/10 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide
fumarate equivalent to 10 mg
of tenofovir alafenamide.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Grey, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x
6.4 mm debossed with “GSI”
on one side and “210” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Descovy is indicated in combination with other antiretroviral agents
for the treatment of adults and
adolescents (aged 12 years and older with body weight at least 35 kg)
infected with human
immunodeficiency virus type 1 (HIV-1) (see sections 4.2 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
Descovy should be administered as shown in Table 1.
TABLE 1: DOSE OF DESCOVY ACCORDING TO THIRD AGENT IN THE HIV TREATMENT
REGIMEN
DOSE OF DESCOVY
THIRD AGENT IN HIV TREATMENT REGIMEN
(see section 4.5)
Descovy 200/10 mg once
daily
Atazanavir with ritonavir or cobicistat
Darunavir with ritonavir or cobicistat
1
Lopinavir with ritonavir
Descovy
200/25 mg once
daily
Dolutegravir, efavirenz, maraviroc,
nevirapine, rilpivirine, raltegravir
1
Descovy 200/10 mg in combination with darunavir 800 mg and cobicistat
150 mg, administered as a fixed-dose
combination tablet, was studied in treatment-naive subjects, see
section 5.1.
_Missed doses _
If the patient misses a dose of Descovy within 18 hours of the time it
is usually taken, the patient
should take Descovy as soon as possible and resume the normal dosing
schedule. If a patient misses a
dose of Descovy 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 Descovy another tablet
should be taken.
_Elderly_
No dose adjustment of Descovy is req