Label: 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, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this label carefully before starting to take this medicine, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this label. See section 4.

Biktarvy contains three active ingredients:

• bictegravir,a medication known as an integrase strand transfer inhibitor (INSTI)
• emtricitabina,a medication known as a nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamida,a medication 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 present in the body. This improves the immune system and decreases the risk of developing diseases associated with HIV infection.

Do not take Biktarvy

• If you are allergic to bictegravir, emtricitabina, tenofovir alafenamidaor to any of the othercomponents of this medication (listed in section 6 of this leaflet).

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

• If you are taking any of these medications,do not take Biktarvy and consult your doctorimmediately.

Warnings and precautions

Consult your doctor before starting to take 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, and who are being treated with antiretrovirals have a higher risk of developing severe and potentially life-threatening liver complications. If you have hepatitis B infection, your doctor will carefully evaluate the best treatment plan for you.

• If you have hepatitis B.Liver problems may worsen after stopping Biktarvy.

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

While 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, inform 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 prolonged period.

You can still transmit HIV to others while taking Biktarvy, although effective antiretroviral treatment reduces the risk. Consult your doctor about the necessary precautions to avoid infecting others. This medication is not a cure for HIV infection. While you are taking Biktarvy, you may still experience infections or other diseases associated with HIV infection.

Children and adolescents

Do not administer this medication to children and adolescents under 18 years of age.This medication has not yet been studied in children and adolescents under 18 years of age.

Other medications and Biktarvy

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.Biktarvy may interact with other medications.As a result, the blood levels of Biktarvy or other medications may be affected. This may prevent your medications from working correctly or worsen their possible side effects. In some cases, your doctor may need to adjust the dose or check your blood concentrations.

Medications that should never be taken with Biktarvy:

• rifampicinused to treat some bacterial infections such as tuberculosis
• St. John's Wort(Hypericum perforatum, St. John's Wort), a plant-based medication used to treat depression and anxiety, or products that contain it.

• If you are taking any of these medications,do not take Biktarvy and inform your doctorimmediately.

Consult your doctor if you are taking:

• medications used to treat HIV and/or hepatitis Bthat contain:
• • adefovir dipivoxil, atazanavir, bictegravir, emtricitabina, lamivudina, tenofovir alafenamida, or tenofovir disoproxilo
• antibiotics, used to treat bacterial infections, that contain:
• • azitromicina, claritromicina, rifabutina, or rifapentina
• antiepileptics,used to treat epilepsy, that contain:
• • carbamazepina, oxcarbazepina, phenobarbital, or phenitoína
• immunosuppressants,used to control the body's immune response after atransplant, that contain ciclosporina
• medications for ulcer healingthat contain sucralfato

• Inform your doctor if you are taking any of these medications.Do not interrupt yourtreatment without consulting your doctor.

Consult your doctor or pharmacist if you are taking:

• antacidsto treat stomach ulcers, acid reflux, or heartburn, that containaluminum hydroxide and/or magnesium hydroxide
• mineral or vitamin supplements,that contain magnesium or iron

Antacids and magnesium supplements:You will need to take Biktarvy at least 2 hoursbeforetaking the antacids or supplements that contain aluminum and/or magnesium. Or you can take Biktarvy with food at least 2 hoursaftertaking the antacid or supplement that contains aluminum and/or magnesium.

Iron supplements:You will need to take Biktarvy at least 2 hoursbeforetaking the iron supplements or you can take them all together with food.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.
• Inform your doctor immediately if you become pregnant and ask about the possible benefits and risks of your antiretroviral treatment for you and your child.

If you have taken Biktarvy during your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of HIV protection was greater than the risk of adverse effects.

Do not breastfeed your child during Biktarvy treatment.This is because some of the active ingredients in this medication pass into breast milk. It is recommended that you do not breastfeed to avoid transmitting the virus to the child through breast milk. If you really want to breastfeed, talk to your doctor first.

Driving and operating machinery

Biktarvy may cause dizziness. If you experience dizziness during Biktarvy treatment, do not drive or operate tools or machinery.

Biktarvy contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow the exact administration instructions for this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:one tablet per day, with or without food

Do not chew, crush, or divide the tablet.

• Consult your doctor or pharmacist if you are taking:

• antacidsto treat stomach ulcers, acid reflux, or heartburn, containingaluminum and/or magnesium hydroxide
• mineral supplementsorvitaminscontaining magnesium or iron

• See section 2 for more informationon how to take these medications 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 possible side effects with this medication (see section 4,Possible side effects).

Consult your doctor immediately or go to the nearest emergency service. Bring the tablet container with you so that you can easily describe what you have taken.

If you forget to take Biktarvy

It is essential not to forget a dose of Biktarvy.

If you forget a dose:

• If you realize within 18 hoursafter the time you normally take Biktarvy, take the tablet as soon as possible. Then take the next dose as usual.
• If you realize after 18 hours or moreafter the time you normally take Biktarvy, do not take the missed dose. Wait and take the next dose at the usual time.

If you vomitbefore 1 hour after taking Biktarvy, take another tablet. Ifyou vomit 1 hour after taking Biktarvy, you do not need to take another tablet until the usual time.

Do not interrupt treatment with Biktarvy

Do not interrupt treatment with Biktarvy without first speaking with your doctor.Interrupting Biktarvymay severely affect the functioning of future treatments. If Biktarvy is interrupted for any reason, consult with your doctor before restarting the tablet intake of Biktarvy.

When you see that you have little Biktarvy left,visit your doctor or pharmacist to obtain more. This is very important, as the virus load may start to increase if the medication is interrupted even for a short period of time. It is possible that the disease will then become more difficult to treat.

If you have HIV and hepatitis Binfection, it is especially important not to suspend your treatmentwith Biktarvy without first speaking with your doctor. You may need to have blood tests for several months after suspending treatment. In some patients with advanced liver disease or cirrhosis, treatment is not recommended as this may lead to a worsening of hepatitis, a potentially fatal situation.

• Talk to your doctor immediatelyabout new or unusual symptoms after suspending treatment, particularly symptoms associated with hepatitis B infection.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Possible side effects: report to a doctor immediately

• Any sign of inflammation or infection.In some patients with advanced HIV (AIDS) infection and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting HIV treatment. It is believed that these symptoms are due to an improvement in the body's immune response, which allows it to fight off infections that may have been present without obvious symptoms.

• Side effects may also occurautoimmune disorders,in which the immune system attacks healthy tissues in the body, after starting treatment for HIV infection. Autoimmune disorders can occur many months after starting treatment. Be aware of any symptoms of infection or other symptoms, such as:

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

Common side effects

(may affect up to 1 in 10 people)

• depression
• abnormal dreams
• headache
• dizziness
• diarrhea
• nausea (gagging)
• fatigue (fatigue)

Less common side effects

(may affect up to 1 in 100 people)

• anemia

• vomiting

• stomach pain

• digestive problems that cause discomfort after eating (indigestion)

• gas (flatulence)

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

• itching (pruritus)

• eruption

• hives (urticaria)

• joint pain (arthralgia)

• suicidal behavior

• anxiety

• sleep disorders

Blood tests may also show:

• Higher concentrations of substances called bilirubin and/or serum creatinine in the blood

• If you consider any of the side effects you are experiencing to be severe, report them to your doctor.

Other effects that may be observed during HIV treatment

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

• Bone problems.Some patients treated with combination antiretroviral medicationssuch as Biktarvy may develop a bone disease calledosteonecrosis(bone tissue death due to a loss of blood supply to the bone). Taking this type of medication for a prolonged period, taking corticosteroids, drinking alcohol, having a severely weakened 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 (especially in the hip, knee, and shoulder)
  • difficulty moving

• If you notice any of these symptoms, report them to your doctor.

During HIV treatment, there may be an increase in weight and blood glucose and lipid levels. This may be partly related to recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directlythrough the national notification system included in theAppendix V.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the bottle after {CAD}. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Biktarvy

The active principles arebictegravir, emtricitabina and tenofovir alafenamida. Each Biktarvy tablet contains bictegravir sodium equivalent to 50 mg of bictegravir, 200 mg of emtricitabina and tenofovir alafenamida fumarate equivalent to 25 mg of tenofovir alafenamida.

The other components are

Tablet core

Microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating

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

Appearance of the product and contents of the pack

The film-coated tablets of Biktarvy are brown-purple film-coated tablets, capsule-shaped, marked on one face of the tablet with «GSI» and on the other face of the tablet with «9883». Biktarvy is presented in bottles of 30 tablets and in packs of 3 bottles, each containing 30 tablets. Each bottle contains a silica gel desiccant that must 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 taken.

Only some pack sizes may be marketed.

Marketing authorisation holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Irlanda

Responsible for manufacturing

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Irlanda

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet:

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