BIKTARVY 50 mg/200 mg/25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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. The last section of this leaflet includes information on how to report side effects.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Biktarvy and what is it used for
2. What you need to know before you take Biktarvy
3. How to take Biktarvy
4. Possible side effects
5. Storage of Biktarvy
6. Contents of the pack and other information

1. What is Biktarvy and what is it used for

Biktarvy contains three active substances:

• bictegravir,an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI)
• emtricitabine,an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide,an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)

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 improves your immune system and reduces the risk of developing diseases associated with HIV infection.

2. What you need to know before you take Biktarvy

Do not take Biktarvy

• If you are allergic to bictegravir, emtricitabine, tenofovir alafenamideor any of the other ingredients of this medicine (listed in section 6).

• If you are currently taking any of the following medicines:
• • rifampicinused to treat some bacterial infections such as tuberculosis
  • St. John's Wort(Hypericum perforatum, hypericum), a herbal medicine used for depression and anxiety, or products that contain it.

• If you are taking any of these medicines, do not take Biktarvy and consult your doctor immediately.

Warnings and precautions

Consult your doctor before you start taking Biktarvy:

• If you have liver problems or a history of liver disease, including hepatitis.Patients with liver disease, such as chronic hepatitis B or C, who are treated with antiretrovirals are at a higher risk of developing serious and potentially life-threatening liver problems. If you have a hepatitis B infection, your doctor will carefully evaluate the best treatment for you.

• If you have hepatitis B.Liver problems may get worse after you stop taking Biktarvy.

• Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first. You can find more information in section 3, Do not stop taking Biktarvy.

While you are taking Biktarvy

Once you start taking Biktarvy, be aware of:

• Signs of inflammation or infection
• Joint pain, stiffness or bone problems

• If you notice any of these symptoms, tell your doctor immediately.You can find more information in section 4, Possible side effects.

Although kidney problems have not been observed with Biktarvy, there is a possibility that you may experience kidney problems if you take Biktarvy for a long time.

While you are taking this medicine you can still pass on HIV to others,even if effective antiretroviral therapy reduces the risk. Consult your doctor about the precautions needed to avoid infecting other people. This medicine is not a cure for HIV infection. While you are taking Biktarvy, you may still develop infections or other illnesses associated with HIV infection.

Children and adolescents

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 been studied.

Other medicines and Biktarvy

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 levels of Biktarvy or other medicines in your blood may be affected. This may stop your medicines from working properly or may increase your risk of side effects. In some cases, your doctor may need to adjust your dose or check your blood levels.

Medicines that must not be taken with Biktarvy:

• rifampicinused to treat some bacterial infections such as tuberculosis
• St. John's Wort(Hypericum perforatum, hypericum), a herbal medicine used for depression and anxiety, or products that contain it.

• If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.

Tell your doctor if you are taking:

• medicines used to treat HIV and/or hepatitis Bthat contain:
• • adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide or tenofovir disoproxil
• antibiotics,used to treat bacterial infections, that contain:
• • azithromycin, clarithromycin, rifabutin or rifapentine
• antiepileptics,used to treat epilepsy, that contain:
• • carbamazepine, oxcarbazepine, phenobarbital or phenytoin
• immunosuppressants,used to control the immune response of the body after a transplant, that contain ciclosporin
• medicines for the treatment of ulcersthat contain sucralfate

• Tell your doctor if you are taking any of these medicines.Do not stop your treatment without consulting your doctor.

Consult your doctor or pharmacist if you are taking:

• antacidsfor stomach ulcers, stomach acid or acid reflux, that contain aluminium and/or magnesium hydroxide
• mineral supplementsor vitamin supplementsthat contain magnesium or iron

• Consult your doctor or pharmacist before taking Biktarvyif you are taking any of these medicines.

Antacids and magnesium supplements:you will need to take Biktarvy at least 2 hours beforetaking antacids or supplements that contain aluminium and/or magnesium. Or you can take Biktarvy with food at least 2 hours aftertaking the antacid or supplement that contains aluminium and/or magnesium.

Iron supplements:you will need to take Biktarvy at least 2 hours beforetaking iron supplements or you can take them together with food.

Pregnancy and breast-feeding

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Tell your doctor immediately if you become pregnant and ask about the benefits and risks of your antiretroviral therapy for you and your child.

If you have taken Biktarvy during your pregnancy, your doctor may request that you have 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 of protection against HIV was greater than 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 breast milk. It is recommended that you do not breast-feed to prevent passing on the virus to your child through breast milk. If you really want to breast-feed, talk to your doctor first.

Driving and using machines

Biktarvy may cause dizziness. If you feel dizzy while taking Biktarvy, do not drive or use tools or machines.

Biktarvy contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially “sodium-free”.

3. How to take Biktarvy

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults:one tablet each day, with or without food

Do not chew, crush or split the tablet.

• Consult your doctor or pharmacist if you are taking:

• antacidsfor stomach ulcers, stomach acid or acid reflux, that contain aluminium and/or magnesium hydroxide
• mineral supplementsor vitamin supplementsthat contain magnesium or iron

• See section 2 for more informationon how to take these medicines with Biktarvy.

If you take more Biktarvy than you should

If you take more than the recommended dose of Biktarvy, you may be at a higher risk of experiencing side effects with this medicine (see section 4, Possible side effects).

Consult your doctor immediately or go to the emergency department at your nearest hospital. Take the pack with you.

If you forget to take Biktarvy

It is important that you do not miss a dose of Biktarvy.

If you forget a dose:

• If you notice within 18 hoursof the time you would normally take Biktarvy, you should take the tablet as soon as possible. Then take the next dose at the usual time.
• If you notice after 18 hours or moreof the time you would normally take Biktarvy, do not take the missed dose. Wait and take the next dose at the usual time.

If you vomitwithin 1 hour of 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 normal dose.

Do not stop taking Biktarvy

Do not stop taking Biktarvy without talking to your doctor first.Stopping Biktarvy may seriously affect the effectiveness of future treatments. If Biktarvy is stopped for any reason, consult your doctor before starting to take Biktarvy tablets again.

When you have nearly finished a pack of Biktarvy,make an appointment with your doctor or pharmacist to get a new pack. This is very important, as the amount of virus in your blood may start to increase if the medicine is stopped, even for a short time. This may make your disease more difficult to treat.

If you have HIV and hepatitis Bit is especially important not to stop your treatment with Biktarvy without talking to your doctor first. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this may lead to worsening of your hepatitis, which can be life-threatening.

• Talk to your doctor immediatelyabout new or unusual symptoms after stopping treatment, particularly symptoms that you think may be related to hepatitis B infection.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects: tell a doctor immediately

• Any sign of inflammation or infection.In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to an improvement in the immune system, which enables the body to fight off these infections.

• Autoimmune disorders, where the immune system attacks healthy body tissue, may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after the start of treatment. Be aware of any symptoms of infection or other symptoms such as:

• muscle weakness
• weakness that starts in the hands and feet and moves up towards the trunk
• palpitations, tremor or hyperactivity

• If you notice any of these symptoms or any symptoms of inflammation or infection, tell your doctor immediately.

Common side effects

(may affect up to 1 in 10 people)

• depression
• abnormal dreams
• headache
• dizziness
• diarrhoea
• feeling sick (nausea)
• fatigue

Uncommon side effects

(may affect up to 1 in 100 people)

• anaemia

• vomiting

• stomach pain

• indigestion

• wind (flatulence)

• swelling of the face, lips, tongue or throat (angioedema)

• itching (pruritus)

• rash

• hives (urticaria)

• joint pain (arthralgia)

• suicidal behaviour

• anxiety

• sleep disorders

Blood tests may also show:

• higher levels of substances called bilirubin and/or serum creatinine in the blood

• If you think any of the side effects you are experiencing are serious, tell your doctor.

Other effects that may be seen during HIV treatment

The frequency of the following side effects is not known (the frequency cannot be estimated from the available data).

• Bone problems.Some patients treated with combination antiretroviral therapy like Biktarvy may develop a bone disease called osteonecrosis(death of bone tissue due to loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a weak immune system and being overweight, may be some of the many risk factors for developing this disease. The signs of osteonecrosis are:
• • joint stiffness
  • joint pain or pain in the limbs (especially the hip, knee and shoulder)
  • difficulty moving

• If you notice any of these symptoms, tell your doctor.

During HIV treatment, weight and levels of blood sugars and fats may increase. This may be due in part to the recovery of your natural immune system and, for blood fats, to the antiretroviral therapy itself. Your doctor will monitor these changes.

Reporting of side effects

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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Biktarvy

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 on the bottle after {CAD}. The expiry date refers to the last day of that month.

Store in the original package to protect from moisture. Keep the bottle tightly closed. Do not use if the seal is broken or missing.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Container Content and Additional Information

Biktarvy Composition

The active ingredients arebictegravir, 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, sodium croscarmellose, magnesium stearate.

Film Coating

Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), black iron oxide (E172).

Product Appearance and Container Content

The Biktarvy film-coated tablets are purple-brown, capsule-shaped tablets, marked on one side of the tablet with «GSI» and on the other side of the tablet with «9883». Biktarvy is available in bottles of 30 tablets and in packs of 3 bottles, each containing 30 tablets. Each bottle contains a silica gel desiccant that should be kept in the bottle to help protect the tablets. The silica gel desiccant is contained in a separate sachet or container and should not be swallowed.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.