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This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
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The product code(s) for this leaflet is: PLGB11972/0008.
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Biktarvy 50 mg/200 mg/25 mg film-coated tablets
bictegravir/emtricitabine/tenofovir alafenamide
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What Biktarvy is and what it is used for
2. What you need to know before you take Biktarvy
3. How to take Biktarvy
4. Possible side effects
5. How to store Biktarvy
6. Contents of the pack and other information
Biktarvy contains three active substances:
Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults.
Biktarvy reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.
Talk to your doctor before taking Biktarvy:
Once you start taking Biktarvy, look out for:
Although kidney problems have not been observed with Biktarvy, there is a possibility that you may experience kidney problems when taking Biktarvy over a long period of time (see Warnings and precautions).
You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people. This medicine is not a cure for HIV infection. While taking Biktarvy you may still develop infections or other illnesses associated with HIV infection.
Do not give this medicine to children and adolescents under 18 years of age. The use of Biktarvy in children and adolescents under 18 years of age has not yet been studied.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Biktarvy may interact with other medicines. As a result, the amounts of Biktarvy or other medicines in your blood may change. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.
Medicines that must never be taken with Biktarvy:
Talk to your doctor if you are taking:
Get advice from a doctor or pharmacist if you are taking:
If you have taken Biktarvy during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Do not breast-feed during treatment with Biktarvy. This is because some of the active substances in this medicine pass into human breast milk. It is also recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk. If you really want to breastfeed, talk to your doctor first.
Biktarvy can cause dizziness. If you feel dizzy when taking Biktarvy, do not drive and do not use any tools or machines.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults: one tablet each day with or without food
Do not chew, crush or split the tablet.
The Biktarvy 30 day blister pack contains four 7-blister strips and one 2-blister strip. To help track taking your medication over 30 days, the 7-blister strips have days of the week printed and you can write the relevant days of the week on the 2-blister strip. The 90-day multipack contains three 30-day packs together.
If you are on dialysis, take your daily dose of Biktarvy following completion of dialysis.
If you take more than the recommended dose of Biktarvy you may be at higher risk of side effects of this medicine (see section 4, Possible side effects).
Contact your doctor or nearest emergency department immediately for advice. Keep or take the tablet bottle or carton with you so that you can easily describe what you have taken.
It is important not to miss a dose of Biktarvy.
If you do miss a dose:
If you vomit less than 1 hour after taking Biktarvy, take another tablet. If you vomit more than 1 hour after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.
Do not stop taking Biktarvy without talking to your doctor. Stopping Biktarvy can seriously affect how future treatment works. If Biktarvy is stopped for any reason, speak to your doctor before you restart taking Biktarvy tablets.
When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time. The disease may then become harder to treat.
If you have both HIV infection and hepatitis B, it is especially important not to stop your Biktarvy treatment without talking to your doctor first. You may require blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects: tell a doctor immediately
Common side effects
(may affect up to 1 in 10 people)
Uncommon side effects
(may affect up to 1 in 100 people)
Blood tests may also show:
Rare side effects
(may affect up to 1 in 1000 people)
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle or blister strips after {EXP}. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not use if the seal over the bottle opening is broken or missing.
Store in the original package in order to protect from moisture. Do not use if foil over blister is broken or pierced.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substances are bictegravir, emtricitabine and tenofovir alafenamide. Each Biktarvy tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
The other ingredients are
Tablet core
Microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Film-coating
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide red (E172), iron oxide black (E172).
Biktarvy film-coated tablets are purplish-brown, capsule-shaped, film-coated tablets debossed on one side with “GSI” and “9883” on the other side.
The tablets may be supplied either in a bottle or in a blister pack. Not all pack sizes may be marketed.
Bottle
Biktarvy comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets. Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.
Blister
Biktarvy also comes in blister packs of 30 tablets and in multipacks comprising 3 cartons, each containing 30 tablets. Each individual pack contains 4 x blister strips containing 7 tablets and 1 x blister strip containing 2 tablets.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 01/2022.
BVY-21-12746