Biktarvy

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Bictegravir sodium 52.45mg equivalent to to 50 mg bictegravir;  ; Emtricitabine 200mg;  ;  ;  ;  ; Tenofovir alafenamide fumarate 28.04mg equivalent to to 25 mg tenofovir alafenamide;  

MAH:

Gilead Sciences (NZ)

pharmaceutical_form:

Film coated tablet

composition:

Active: Bictegravir sodium 52.45mg equivalent to to 50 mg bictegravir   Emtricitabine 200mg         Tenofovir alafenamide fumarate 28.04mg equivalent to to 25 mg tenofovir alafenamide   Excipient: Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry brown 85F165072

prescription_type:

Prescription

therapeutic_indication:

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.

leaflet_short:

Package - Contents - Shelf Life: Bottle, HDPE, 100 mL with CRC PP cap, desiccant and aluminium foil liner - 30 tablets - 36 months from date of manufacture stored at or below 30°C

authorization_date:

2019-01-07

PIL

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

SPC

NEW ZEALAND DATA SHEET
BIKTARVY Data Sheet v 8.0 (24 August 2023)
Page 1
1 BIKTARVY
® (BICTEGRAVIR/EMTRICTABINE/TENOFOVIR ALAFENAMIDE
50/200/25 MG) TABLETS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bictegravir 50 mg (BIC) / Emtricitabine 200 mg (FTC) / Tenofovir
alafenamide 25 mg
(TAF).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
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 25kg 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.
Special populations: Dosage adjustment
_ELDERLY:_
No dose adjustment is required for elderly patients.
NEW ZEALAND DATA SHEET
BIKTARVY Data Sheet v 8.0 (24 August 2023)
Page 2
_RENAL IMPAIRMENT:_
No dose adjustment of BIKTARVY is required in adult patients with
estimated creatinine clearance ≥ 30 mL/min or in adult patients with
end stage renal disease
(ESRD; estimated creatinine clearance < 15 mL/min) who are receiving
chronic
haemodialysis. On days of haemodialysis, administer the daily dose of
BIKTARVY after
completion of haemodialysis treatment.
Initiation of BIKTARVY is not recommended in patients with estimated
creatinine
clearance
≥ 15 and < 30 mL/min, or < 15mL/min who