FDA approves Biktarvy

The U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), an integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (Descovy) combination as a once-daily single tablet regimen for the treatment of HIV-1 infection.

Biktarvy is a prescription medicine that is used without other anti-HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults:

who have not received anti-HIV-1 medicines in the past, or

to replace their current anti-HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements.

HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

It is not known if this medicine is safe and effective in children under 18 years of age.

Do not take Biktarvy if you also take a medicine that contains:

dofetilide

rifampin

Biktarvy can cause serious side effects, including:

Worsening of Hepatitis B virus infection. If you have hepatitis B virus (HBV) infection and take Biktarvy, your HBV may get worse (flare-up) if you stop treatment. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.

Do not run out of Biktarvy. Refill your prescription or talk to your healthcare provider before your supply is all gone.

Do not stop treatment without first talking to your healthcare provider. If you do stop treatment, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop treatment.

Before taking Biktarvy, tell your healthcare provider about all your medical conditions, including if you:

have liver problems, including hepatitis B virus infection

have kidney problems

are pregnant or plan to become pregnant. It is not known if Biktarvy can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment.

Pregnancy Registry: There is a pregnancy registry for women who take Biktarvy during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.

are breastfeeding or plan to breastfeed. Do not breastfeed if you take Biktarvy.

You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

At least one of the medicines in Biktarvy can pass to your baby in your breast milk. It is not known if the other medicines can also pass into your breast milk.

Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements.

Some medicines may interact with Biktarvy. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with Biktarvy.

Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Biktarvy with other medicines.

Take Biktarvy exactly as your healthcare provider tells you to take it. Biktarvy is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection.

Take Biktarvy one time each day with or without food.

Do not change your dose or stop treatment without first talking with your healthcare provider. Stay under a healthcare provider’s care during treatment with Biktarvy.

If you take antacids that contain aluminum, magnesium, or calcium, take Biktarvy on an empty stomach two hours before you take these antacids.

If you take supplements that contain iron or calcium, take these supplements with food at the same time that you take Biktarvy.

Do not miss a dose of Biktarvy.

If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away.

When your supply of tablets starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Biktarvy and become harder to treat.

Biktarvy side effects

Biktarvy may cause serious side effects, including:

Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.

New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys when starting, and during treatment. Your healthcare provider may tell you to stop treatment if you develop new or worse kidney problems.

Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.

Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

The most common side effects are diarrhea, nausea, and headache.

These are not all the possible side effects.

Call your doctor for medical advice about side effects.

Ingredients in Biktarvy

Active ingredients: bictegravir, emtricitabine and tenofovir alafenamide.

Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

 

FDA approves Biktarvy

The U.S. Food and Drug Administration (FDA) has approved Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), an integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (Descovy) combination as a once-daily single tablet regimen for the treatment of HIV-1 infection. Biktarvy is a prescription medicine that is used without other anti-HIV-1 medicines to treat Human Immunodeficiency Virus-1 (HIV-1) in adults: who have not received anti-HIV-1 medicines in the past, or to replace their current anti-HIV-1 medicines for people whose healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes AIDS (Acquired Immune Deficiency Syndrome). It is not known if this medicine is safe and effective in children under 18 years of age. Do not take Biktarvy if you also take a medicine that contains: dofetilide rifampin Biktarvy can cause serious side effects, including: Worsening of Hepatitis B virus infection. If you have hepatitis B virus (HBV) infection and take Biktarvy, your HBV may get worse (flare-up) if you stop treatment. A flare-up is when your HBV infection suddenly returns in a worse way than before. Do not run out of Biktarvy. Refill your prescription or talk to your healthcare provider before your supply is all gone. Do not stop treatment without first talking to your healthcare provider. If you do stop treatment, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection. Tell your healthcare provider about any new or unusual symptoms you may have after you stop treatment. Before taking Biktarvy, tell your healthcare provider about all your medical conditions, including if you: have liver problems, including hepatitis B virus infection have kidney problems are pregnant or plan to become pregnant. It is not known if Biktarvy can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment. Pregnancy Registry: There is a pregnancy registry for women who take Biktarvy during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. Do not breastfeed if you take Biktarvy. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. At least one of the medicines in Biktarvy can pass to your baby in your breast milk. It is not known if the other medicines can also pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, antacids, laxatives, vitamins, and herbal supplements. Some medicines may interact with Biktarvy. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. You can ask your healthcare provider or pharmacist for a list of medicines that interact with Biktarvy. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Biktarvy with other medicines. Take Biktarvy exactly as your healthcare provider tells you to take it. Biktarvy is taken by itself (not with other HIV-1 medicines) to treat HIV-1 infection. Take Biktarvy one time each day with or without food. Do not change your dose or stop treatment without first talking with your healthcare provider. Stay under a healthcare providers care during treatment with Biktarvy. If you take antacids that contain aluminum, magnesium, or calcium, take Biktarvy on an empty stomach two hours before you take these antacids. If you take supplements that contain iron or calcium, take these supplements with food at the same time that you take Biktarvy. Do not miss a dose of Biktarvy. If you take too much or overdose, call your healthcare provider or go to the nearest hospital emergency room right away. When your supply of tablets starts to run low, get more from your healthcare provider or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Biktarvy and become harder to treat. Biktarvy side effects Biktarvy may cause serious side effects, including: Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine. New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys when starting, and during treatment. Your healthcare provider may tell you to stop treatment if you develop new or worse kidney problems. Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat. Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark tea-colored urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain. The most common side effects are diarrhea, nausea, and headache. These are not all the possible side effects. Call your doctor for medical advice about side effects. Ingredients in Biktarvy Active ingredients: bictegravir, emtricitabine and tenofovir alafenamide. Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.