GENVOYA elvitegravir (150mg), cobicistat (150mg), emtricitabine (200mg) and tenofovir alafenamide (as fumarate) (10mg) fixed dose combination tablets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

tenofovir alafenamide fumarate, Quantity: 11.2 mg; emtricitabine, Quantity: 200 mg; elvitegravir, Quantity: 150 mg; cobicistat, Quantity: 150 mg

Available from:

Gilead Sciences Pty Ltd

INN (International Name):

Cobicistat,Elvitegravir,Emtricitabine,tenofovir alafenamide fumarate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: croscarmellose sodium; hyprolose; lactose monohydrate; magnesium stearate; sodium lauryl sulfate; microcrystalline cellulose; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GENVOYA is indicated as a single tablet regimen for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment?na?ve; or virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen at start of therapy in order to replace their current antiretroviral treatment regimen (see 5.1 Pharmacodynamic properties, Clinical Trials). Patients must not have a history of treatment failure or known mutations associated with resistance to the antiretroviral components of GENVOYA. GENVOYA is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide HIV-1 reverse transcriptase inhibitors.

Product summary:

Visual Identification: Film-coated, capsule shaped and green in colour. Each tablet is debossed with 'GSI' on one side and the number "510" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-01-15

Patient Information leaflet

GENVOYA®
1
GENVOYA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING GENVOYA?
GENVOYA contains the active ingredients elvitegravir, cobicistat,
emtricitabine and tenofovir alafenamide in a single tablet.
GENVOYA is used to help control Human Immunodeficiency Virus 1 (HIV-1)
in adults and children weighing at least 25 kg.
For more information, see Section 1. Why am I using GENVOYA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE GENVOYA?
Do not use if you have ever had an allergic reaction to GENVOYA or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
GENVOYA?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with GENVOYA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE GENVOYA?
•
The usual dose is one GENVOYA tablet orally, once daily with food.
More instructions can be found in Section 4. How do I use GENVOYA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING GENVOYA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
GENVOYA.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not breastfeed.
•
Avoid doing things that can spread HIV infection.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how GENVOYA
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your GENVOYA tablets in the bottle with the cap tightly closed
until you take them.
•
Keep GENVOYA tablets in a cool, dry place where it stays below 25°C.
For more information, see Section 5. What should I know while using
GENVOYA? in the full CMI.
6.
ARE THE

Summary of Product characteristics

GENVOYA
Product Information v11.0 – (24 November 2021)
1
AUSTRALIAN PI – GENVOYA
®
(ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR
ALAFENAMIDE) TABLETS
1
NAME OF THE MEDICINE
GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GENVOYA is available as tablets. Each tablet contains 150 mg of
elvitegravir, 150 mg of
cobicistat, 200 mg of emtricitabine, and tenofovir alafenamide
fumarate equivalent to 10 mg
of tenofovir alafenamide. The tablets are film-coated, capsule shaped
and green in colour.
Each tablet is debossed with ‘GSI’ on one side and the number
“510” on the other side.
Contains lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each GENVOYA tablet is capsule shaped, film-coated and green in
colour. Each tablet is
debossed with ‘GSI’ on one side and the number ’510’ on the
other side. The tablets are
supplied in bottles with child resistant closures.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
GENVOYA is indicated as a single tablet regimen for the treatment of
HIV-1 infection in
adults and paediatric patients weighing at least 25 kg who are either
treatment–naïve; or
virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable
antiretroviral regimen at
start of therapy in order to replace their current antiretroviral
treatment regimen (see
5.1Pharmacodynamic properties, Clinical Trials). Patients must not
have a history of
treatment failure or known mutations associated with resistance to the
antiretroviral
components of GENVOYA.
GENVOYA is a fixed dose combination of one integrase inhibitor, one
pharmacokinetic
enhancer and two nucleos(t)ide HIV
‐
1 reverse transcriptase inhibitors.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of GENVOYA is one tablet once daily taken with
food.
GENVOYA
Product Information v11.0 – (24 November 2021)
2
CHILDREN AND ADOLESCENTS UP TO 18 YEARS OF AGE
In paediatric patients weighing ≥ 25 kg, the recomme