DESCOVY 200 mg/10 mg (200 mg emtricitabine/10 mg tenofovir alafenamide) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

emtricitabine, Quantity: 200 mg; tenofovir alafenamide fumarate, Quantity: 11.2 mg (Equivalent: tenofovir alafenamide, Qty 10 mg)

Available from:

Gilead Sciences Pty Ltd

INN (International Name):

Emtricitabine,tenofovir alafenamide fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; magnesium stearate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; iron oxide black

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of HIV-1 Infection: DESCOVY is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DESCOVY (see section 5.1 Pharmacodynamic properties).,HIV-1 Pre-Exposure Prophylaxis: DESCOVY is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex.

Product summary:

Visual Identification: DESCOVY 200 mg/10 mg tablets are gray, rectangular-shaped, film-coated tablets with 'GSI' debossed on one side and '210' on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-07-01

Patient Information leaflet

DESCOVY Consumer Medicine Information v4.0 – (23 January 2020) Page
1 of 5
DESCOVY
® TABLETS
(200 MG EMTRICITABINE / 25 MG TENOFOVIR ALAFENAMIDE AND
200 MG EMTRICITABINE / 10 MG TENOFOVIR ALAFENAMIDE)
_emtricitabine / tenofovir alafenamide_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
This leaflet answers some of the
common questions about DESCOVY
tablets. It does not contain all of the
available information.
It does not take the place of talking to
your doctor or pharmacist about your
medical condition or treatment. If you
have further questions, please ask your
doctor or your pharmacist.
THIS MEDICINE HAS BEEN PRESCRIBED FOR
YOU PERSONALLY AND YOU SHOULD NOT
PASS IT ON TO OTHERS.
It may harm them, even if their
symptoms are the same as yours.
MEDICINES ARE SOMETIMES PRESCRIBED
FOR CONDITIONS THAT ARE NOT MENTIONED
IN THIS LEAFLET.
KEEP THIS LEAFLET WITH YOUR
DESCOVY MEDICINE.
You may need to read it again.
WHAT IS DESCOVY
_HOW _
_DESCOVY WORKS_
_ _
DESCOVY tablets consist of the
following medicines:
•
emtricitabine
•
tenofovir alafenamide
These are combined in one tablet to help
control Human Immunodeficiency Virus
(HIV) infection.
DESCOVY helps block HIV-1 reverse
transcriptase, a viral chemical in your
body (enzyme) that is needed for HIV-1
to multiply.
DESCOVY lowers the amount of HIV
in the blood (viral load). DESCOVY
may also help to increase the number of
T cells (CD4
+
cells), allowing your
immune system to improve. Lowering
the amount of HIV in the blood lowers
the chance of death or infections that
happen when your immune system is
weak (opportunistic infections).
HIV infection destroys CD4 T cells,
which are important to the immune
system. The immune system helps fight
infection. After a large number of T
cells are destroyed, acquired immune
deficiency syndrome (AIDS) may
develop.
DESCOVY is for people who do not
have a resistant HIV virus to
DESCOVY.
Emtricitabine and tenofovir alafenamide
belong to a group

Summary of Product characteristics

DESCOVY Product Information v-4.0– (14 February 2020)
1
AUSTRALIAN PI – DESCOVY
® (EMTRICITABINE/TENOFOVIR
ALAFENAMIDE) TABLETS
1
NAME OF THE MEDICINE
DESCOVY (200 mg emtricitabine/25 mg tenofovir alafenamide) and DESCOVY
200 mg
emtricitabine/10 mg tenofovir alafenamide ) tablets.
The drug substances in DESCOVY tablets are emtricitabine (FTC) and
tenofovir alafenamide
(TAF) fumarate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DESCOVY is available as tablets.
DESCOVY 200/25 mg tablets contain 200 mg of FTC and TAF fumarate
equivalent to 25 mg
tenofovir alafenamide.
For the full list of excipients, see section 6.1 List of excipients.
DESCOVY 200/10 mg tablets contain 200 mg of FTC and TAF fumarate
equivalent to 10
mg tenofovir alafenamide.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each 200/25 mg DESCOVY tablet is rectangular shaped, film-coated and
blue in colour.
Each tablet is debossed with ‘GSI’ on one side and the number
“225” on the other side. Each
200/10 mg DESCOVY tablet is rectangular shaped, film-coated and gray
in colour. Each
tablet is debossed with ‘GSI’ on one side and the number “210”
on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
DESCOVY is indicated in combination with other antiretroviral agents
for the treatment of
HIV-1 infection in adults and adolescents aged 12 years and older with
body weight at least
35 kg. The patients must not have a history of treatment failure or
known mutations
associated with resistance to the individual components of DESCOVY
(see section 5.1
Pharmacodynamic properties).
DESCOVY is not indicated for use in Pre
‐
Exposure Prophylaxis (PrEP).
4.2
D
OSE AND METHOD OF ADMINISTRATION
In adults and adolescent patients aged 12 years and older and weighing
≥ 35 kg, DESCOVY
is taken orally once daily with or without food.
The recommended dose of DESCOVY is 200/25 mg.
DESCOVY Product Information v-4.0– (14 February 2020)
2
If DESCOVY is used in combination with an HIV-1 protease i