50 mg / 200 mg / 25 mg film-coated tablets 
biktegravir / emtricitabine / tenofoviralafenamide

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Biktarview is and what it is used for 
2. What you need to know before using Biktarvy 
3. How to use Biktarvy 
4. Possible side effects 
5. How to store Biktarvy 
6. Contents of the packaging and other information 

1. What Confession View is and what it is used for

Biktarvy contains three active substances:

  • biktegravir , an antiretroviral medicine known as an integrase inhibitor (INSTI)
  • emtricitabine, a type antiretroviral drug called a nucleoside reverse transcriptase inhibitor (NRTI)
  • tenofoviralafenamide, an antiretroviral drug of a type called a nucleotide reverse transcriptase inhibitor (NRTI)

Biktarvy is a combination tablet for the treatment of human immunodeficiency virus-1 infection ( HIV -1 ) in adults.

Confession reduces the amount of HIV in the body. This strengthens the immune system and the risk of developing illnesses associated with HIV – infection decreases.

2. What you need to know before using Biktarvy

Do not take Confession View

  • If you are allergic to biktegravir, emtricitabine, tenofoviralafenamide, or any of the other ingredients of this medicine (listed in section 6).

If you are currently taking any of the following medicines:

  • rifampicin is used to treat certain bacterial infections such as tuberculosis
  • St. John’s wort ( Hypericum perforatum) , an herbal medicine used for mild depression and mild anxiety or products containing St. John’s wort.

→ If any of these apply to you, do not take Confession and inform your doctor immediately.

Warnings and cautions

Talk to a doctor before taking Biktarview:

  • If you have liver problems or have previously had liver disease, including hepatitis. Patients with liver disease including chronic hepatitis B or C, who are being treated with antiretroviral therapy, have a higher risk of severe and potentially fatal liver complications. If you have a hepatitis B infection, your doctor will carefully consider the best treatment for you.
  • If you have hepatitis B infectionLiver problems may get worse after you stop taking Biktarvy.

→ Do not stop taking Biktarview if you have hepatitis B. Talk to your doctor first. For more information, see section 3, Do not stop taking Confession View.

During the time you take Biktarvy

Once you have started taking Biktarvy, you should be observant of:

  • ecken of inflammation or infection
  • Joint pain, stiffness, or problems with the skeleton

→ Contact your doctor immediately if you get any of these symptoms. See section 4, Possible side effects, for more information.

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

You can still transmit HIV infection while taking this medicine, even though the risk of effective antiretroviral therapy is reduced. Discuss with your doctor the necessary steps to avoid infecting others. This medicine does not cure HIV – infection. While taking Biktarvy, you may still develop infections you 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 for children and young people under the age of 18 has not yet been studied.

Other drugs and Confession view

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Confession may affect or be affected by other drugs. This can lead to changes in the amount of Biktarvy or other medicines in the blood. Then the medicines may not work properly or any side effects may get worse. In some cases, your doctor may need to change your dose or check the amount of medicine in your blood.

Medicines that must never be taken with Biktarvy:

  • rifampicin (used to treat certain bacterial infections such as tuberculosis )
  • St. John’s wort ( Hypericum perforatum) , an herbal medicine used for mild depression and anxiety) or products containing it.

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

Talk to your doctor if you are taking:

  • medicines used to treat HIV and/or hepatitis B, which contain:
    • adefovir dipivoxil, atazanavir, biktegravir, emtricitabine, lamivudine, tenofoviralafenamide, or tenofovir disoproxil
  • antibiotics used to treat bacterial infections, which contain:
    • azithromycin, clarithromycin, rifabutin, or rifapentine
  • antiepileptics used to treat epilepsy, such as:
    • carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
  • immunosuppressive used to suppress the body’s immune system after transplantation, containing:
    • cyclosporine
  • gastric ulcer drugs, containing:
    • sucralfate

→  Contact your doctor if you are taking any of these medicines. You should not stop treatment without talking to your doctor.

Talk to your doctor or pharmacist if you are taking:

  • antacids to treat stomach ulcers, heartburn, or reflux disease, containing aluminum and/or magnesium hydroxide
  • mineral supplements or vitamins, which contain magnesium or iron

→ If you are taking any of these medicines, talk to your doctor or pharmacist before taking Biktarvy .

Antacids and magnesium supplements: you must take Biktarvy at least 2 hours before antacids or supplements that contain aluminum and/or magnesium. Or you can take Biktarvy together with food for at least 2 hours afterward.

Iron supplements: you must take Biktarvy at least 2 hours before iron supplements, or you can take them with food.

Pregnancy, breastfeeding, and fertility

  • 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 possible benefits or risks of your antiretroviral treatment for you and your baby.

If you have taken Biktarvy during pregnancy, your doctor may request regular blood tests and other diagnostic tests to check your baby’s development. For children whose mother has taken reverse nucleotide-type transcriptase inhibitors (NRTIs) during pregnancy, the benefit of HIV protection outweighs 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. To avoid transmitting HIV to your baby through breast milk, do not breast-feed your baby. If you really want to breastfeed, talk to your doctor first.

Driving and using machines

Confession can cause dizziness. Do not drive or use any tools or machines if you feel dizzy while taking Biktarvy.

Confession view contains excipients

Confession view contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Biktarview

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is:

Adults: one tablet a day with or without food.

You must not chew, crush, or split the tablet.

→ Talk to your doctor or pharmacist if you are taking:

  • antacids to treat stomach ulcers, heartburn, or reflux disease, containing aluminum and/or magnesium hydroxide
  • mineral supplements or vitamins, which contain magnesium or iron

→ See section 2 for more information on taking these medicines with Biktarvy.

If you are on dialysis, take your daily dose of Biktarvy after dialysis has been completed.

If you take more Biktarvy than you should

If you take more than the prescribed dose of Biktarvy you may be at greater risk of side effect s of this medicine (see section 4, Possible side effects s ).

Contact your doctor or nearest emergency department immediately for advice. Save the jar so you can easily describe what you have taken.

If you forgot to take the Confessional view

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

If you miss a dose:

  • If you remember it within 18 hours of the time you usually take Biktarvy, you must take the tablet as soon as possible. Then take the next dose as usual.
  • If you notice it after 18 hours or more, do not take the missed dose. Wait and take the next dose at the usual time.

If you vomit in less than 1 hour after a dose of Biktarvy, take a new tablet. If you vomit more than 1 hour after taking Biktarvy, you do not need to take a new tablet until the next normally scheduled dose.

Do not stop taking Confession View

Do not stop taking Biktarvy without talking to your doctor. If you stop taking Biktarvy, this can seriously affect how well the future treatment works. If for any reason you stop taking Biktarvy, talk to your doctor before taking Biktarvy tablets again.

When your Biktarvy supply starts to run low, get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase even if you only stop taking the medicine for a short time. The disease can then become more difficult to treat.

If you have both HIV – infection and hepatitis B, it is especially important not to stop Biktarvy treatment without first talking to your doctor. You may need to submit blood samples for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is recommended not to discontinue treatment, as it may lead to worsening of the liver disease, and it may be life-threatening.

→ Tell your doctor immediately about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection.

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

4. Possible side effects

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

Possible side effects: Contact a doctor immediately

  • Signs of inflammation or infection. In some patients with advanced HIV – infection ( AIDS ) who have a history of opportunistic infection, you ( infection s that occur in people with weakened immune systems) may be signs and symptoms of inflammation from previous infections that occur shortly after HIV treatment is started. It is believed that these symptoms are due to the fact that the body’s immune system has been strengthened so that the body can fight infections that may have been present without giving any clear symptoms.
  • Autoimmune diseases , where the immune system attacks healthy body tissue, can also occur after you start taking medicines for HIV – infection. Autoimmune diseases can occur many months after starting treatment. Be observant of symptoms of infection or other symptoms such as:
    • muscle weakness
    • weakness that begins in the hands and feet and moves towards the torso
    • palpitations, tremors, or hyperactivity

→  If you notice these or other symptoms of inflammation or infection, tell your doctor immediately.

Common side effects are

(may affect up to 1 in 10 people)

  • Depression
  • abnormal dreams
  • headache
  • dizziness
  • diarrhea
  • nausea
  • fatigue

Uncommon side effects are

may affect up to 1 in 100 people )

  • low red blood cell count ( anemia )
  • vomiting
  • abdominal pain
  • indigestion which results in discomfort after meals ( dyspepsia )
  • gas production ( flatulence )
  • swelling of the face, lips, tongue, or throat ( angioedema )
  • itching ( pruritus )
  • rash
  • hives ( urticaria )
  • joint pain ( arthralgia )
  • suicidal ideation and suicide attempts (especially in patients with a history of depression or mental health problems)
  • anxiety
  • sleep disorders

Blood tests may also show:

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

→  If any side effects get worse, talk to your doctor.

Other effects that can be seen with HIV treatment

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

  • Skeletal problem. Some patients taking combination antiretroviral medicines such as Biktarvy may develop a skeletal disease called osteonecrosis (bone tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing this disease are long-term use of this type of drug, treatment with corticosteroids, alcohol consumption, a very weak immune system, and obesity. Signs of osteonecrosis are:
    • joint stiffness
    • joint pain and pain (especially in hips, knees, and shoulders)
    • mobility difficulties

→  Tell your doctor if you notice any of these symptoms.

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store 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 can after {EXP}. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive. Close the jar tightly. Do not use if the seal on the jar 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. Contents of the packaging and other information

Content declaration

The active substances are biktegravir, emtricitabine, and tenofoviralafenamide. Each Biktarvy tablet contains biktegravir sodium equivalent to 50 mg biktegravir, 200 mg emtricitabine, and tenofoviralafenamide fumarate equivalent to 25 mg tenofoviralafenamide.

Other ingredients are

Tablet core

Microcrystalline cellulose, croscarmellose sodium, magnesium stearate

Film coating

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

What the medicine looks like and the contents of the pack

Biktarvy film-coated tablets are purple-brown, capsule-shaped tablets. Embossed on one side with “GSI” and “9883” on the other side.

Biktarview is available in jars with 30 tablets and in packages consisting of 3 jars, each with 30 tablets.

The jar contains a desiccant in the form of silica gel which must be stored in the jar to protect the tablets. The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Gilead Sciences Ireland UC

Carrigtohill

County Cork, T45 DP77

Ireland

Manufacturer

Gilead Sciences Ireland UC

IDA Business & Technology Park

Carrigtohill

County Cork

Ireland

Muhammad Nadeem

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