Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
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
Gilead Sciences Pty Ltd
Tablet, film coated
Excipient Ingredients: microcrystalline cellulose; magnesium stearate; croscarmellose sodium; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black
Oral
30
(S4) Prescription Only Medicine
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.
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: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2018-07-12
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 Pročitajte cijeli dokument
BIKTARVY Product Information v 10.0 – (01 April 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 Pročitajte cijeli dokument