BIKTARVY bictegravir (as sodium) 50 mg, emtricitabine 200 mg, tenofovir alafenamide (as fumarate) 25 mg fixed-dose combination tablets blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

bictegravir sodium, Quantity: 52.45 mg (Equivalent: bictegravir, Qty 50 mg); tenofovir alafenamide fumarate, Quantity: 28.04 mg (Equivalent: tenofovir alafenamide, Qty mg); emtricitabine, Quantity: 200 mg

Διαθέσιμο από:

Gilead Sciences Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

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

Οδός χορήγησης:

Oral

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

BIKTARVY is indicated for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are antiretroviral therapy (ART)-na?ve or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen at the start of therapy with no history of treatment failure, and no known substitutions associated with resistance to the individual components of BIKTARVY.

Περίληψη προϊόντος:

Visual Identification: Capsule-shaped, film-coated purplish-brown, debossed with GSI on one side of the tablet and 9883 on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2021-08-02

Φύλλο οδηγιών χρήσης

BIKTARVY®
1
BIKTARVY®
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.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING BIKTARVY?
BIKTARVY contains the active ingredients bictegravir, emtricitabine
and tenofovir alafenamide in a single tablet. BIKTARVY is
used to help control Human Immunodeficiency Virus 1 (HIV-1) infection
in adults and children weighing at least 25 kg.
For more information, see Section 1. Why am I using BIKTARVY? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BIKTARVY?
Do not use if you have ever had an allergic reaction to BIKTARVY 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
BIKTARVY?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BIKTARVY 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 BIKTARVY?
The usual dose is one BIKTARVY tablet orally, once daily. BIKTARVY
tablets can be taken with or without food.
More instructions can be found in Section 4. How do I use BIKTARVY?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BIKTARVY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
BIKTARVY.
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 BIKTARVY
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your BIKTARVY tablets in the bottle with the cap tightly closed
until you take them.
•
Keep BIK

Αρχείο Π.Χ.Π.

BIKTARVY Product Information v 4.0 – (23 March 2022)
Page 1
▼
This medicinal product is subject to additional monitoring in
Australia due to approval of an extension
of indications. This will allow quick identification of new safety
information. Healthcare professionals are
asked to report any suspected adverse events at
www.tga.gov.au/reporting-problems
.
AUSTRALIAN PRODUCT INFORMATION
BIKTARVY® (BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE)
FILM-COATED TABLETS
1. NAME OF THE MEDICINE
BIKTARVY
®
(bictegravir (as sodium)/emtricitabine/tenofovir alafenamide)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains bictegravir sodium equivalent to 50
mg of bictegravir
(BIC), 200 mg of emtricitabine (FTC), and tenofovir alafenamide (TAF)
fumarate
equivalent to 25 mg of tenofovir alafenamide.
For the full list of excipients, see Section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
The tablets are film-coated, capsule shaped and purplish-brown in
colour. Each tablet is
debossed with ‘GSI’ on one side and the number “9883” on the
other side.
4.CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BIKTARVY is indicated for the treatment of HIV-1 infection in adults
and paediatric
patients weighing at least 25 kg who are antiretroviral therapy
(ART)-naïve or to replace
the current antiretroviral regimen in those who are
virologically-suppressed (HIV-1 RNA
< 50 copies/mL) on a stable antiretroviral regimen at the start of
therapy with no history of
treatment failure, and no known substitutions associated with
resistance to the individual
components of BIKTARVY.
4.2 DOSE AND METHOD OF ADMINISTRATION
In adults and paediatric patients weighing at least 25 kg, the dose of
BIKTARVY is one
tablet taken orally once daily with or without food.
No data are available on which to make a dose recommendation for
paediatric patients
weighing less than 25 kg.
_ _
_ELDERLY: _
No dose adjustment is required for elderly patients.
_ _
_RENAL IMPAIRMENT:_
No dose adjustment of BIKTARVY is required in adult