DESCOVY 200 MG25 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Available from:

GILEAD SCIENCES ISRAEL LTD

ATC code:

J05AR03

Pharmaceutical form:

FILM COATED TABLETS

Composition:

TENOFOVIR ALAFENAMIDE FUMARATE 25 MG; EMTRICITABINE 200 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

GILEAD SCIENCES IRELAND UC, IRELAND

Therapeutic area:

TENOFOVIR DISOPROXIL AND EMTRICITABINE

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).

Authorization date:

2020-03-25

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS)
REGULATIONS - 1986
This medicine is to be supplied by doctor’s prescription only
DESCOVY
® 200 MG/10 MG
DESCOVY
® 200 MG/25 MG
FILM-COATED TABLETS
ACTIVE INGREDIENTS:
Each tablet contains –

Descovy 200 mg/10 mg:
emtricitabine
200mg
tenofovir alafenamide
10mg

Descovy 200 mg/25 mg:
emtricitabine
200mg
tenofovir alafenamide
25mg
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 only for the treatment of
your disease. 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.
This medicine is intended for adults and adolescents 12 years of age
and older, who weigh at least
35 kg.
1.
WHAT IS THE MEDICINE INTENDED FOR
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.
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.
THERAPEUTIC GROUP:
Descovy contains two active substances:

EMTRICITABINE,
is a nucleoside with antiretroviral activity which inhibits the
reverse
transcriptase enzyme (NRTI)

TENOFOVIR ALAFENAMIDE,
is a nucleotide with antiretroviral activity which inhibits the
reverse
transcriptase enzyme (NtRTI)
2.
BEFORE TAKING THE MEDICINE
X.
DO NOT TAKE THIS MEDICINE

IF YOU ARE ALLERGIC TO EMTRICITABINE, TENOFOVIR ALAF

Summary of Product characteristics

1
DESCOVY
®
(EMTRICITABINE/TENOFOVIR ALAFENAMIDE FUMARATE)
FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Descovy
®
200 mg/10 mg
Descovy
®
200 mg/25 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION

Descovy 200 mg/10 mg
Each tablet contains 200 mg of emtricitabine and tenofovir alafenamide
fumarate equivalent to 10
mg of tenofovir alafenamide.

Descovy 200 mg/25 mg
Each tablet contains 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.

Descovy 200mg/10mg:
Grey, rectangular-shaped, film-coated tablet of dimensions
approximately 12.5 mm x 6.4 mm
debossed with “GSI” on one side and “210” on the other side of
the tablet.

Descovy 200 mg/25 mg:
Blue, rectangular-shaped tablets, film-coated tablet of dimensions
approximately 12.5 mm x 6.4
mm debossed on one side with “GSI” and the number “225” 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.
2
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 stud