Biktarvy

Biktarvy is a prescription medication used to treat human immunodeficiency virus (HIV) infection. It comes as a single tablet containing 3 medications: bictegravir, emtricitabine and tenofovir. 

Bictegravir is an integrase strand transfer inhibitor (INSTI), while emtricitabine and tenofovir are both nucleoside analog reverse transcriptase inhibitors (NRTIs). These drugs work by preventing the virus from replicating. 

This medication comes in a tablet form form and is taken by mouth once daily with or without food. 

Common side effects of Biktarvy include diarrhea, nausea, and headache. 

Biktarvy is a prescription medication used as a complete regimen for the treatment of human immunodeficiency type 1 (HIV-1) infection in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Biktarvy. See the “Biktarvy Precautions” section.

Common side effects of Biktarvy include the following:

• Diarrhea
• Nausea
• Headache
• Fatigue
• Abnormal dreams
• Dizziness
• Insomnia

This is not a complete list of Biktarvy side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Other antiretroviral medications, such as: 
  • efavirenz/emtricitabine/tenofovir (Atripla)
  • rilpivirine (Edurant)
  • emtricitabine (Emtriva)
  • elvitegravir, cobicistat, emtricitabine, and tenofovir (Stribild)
  • tenofovir and emtricitabine (Truvada)
  • tenofovir (Viread)
  • adefovir (Hepsera)

• Antacids that contain aluminum, calcium or magnesium, such as:

  • Alka-Seltzer
  • Maalox
  • Mylanta
  • Rolaids
  • Tums
• Anticonvulsants, such as carbamazepine (Tegretol), oxcarbazepine (Oxtellar XR, Trileptal), phenobarbital (Phenobarb), phenytoin (Dilantin)
• Antimycobacterials, such as rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin)
• Metformin
• St. John's Wort

This is not a complete list of Biktarvy drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Biktarvy including the following: 

• Severe acute exacerbations (flare-ups) of hepatitis B. If you are also infected with the hepatitis B virus (HBV), you need medical exams and blood tests to check for HBV getting worse for several months after stopping treatment with Biktarvy. People with hepatitis B virus infection, who take Biktarvy and then stop it, may get flare-ups of their hepatitis. A flare-up is when the disease suddenly returns in a worse way than before.
• Changes in your immune system. Tell your doctor right away if you start having any new symptoms after starting this medication. 
• Kidney damage. Tell your doctor right away if you get the following signs or symptoms of kidney problems:
  • changes in how often you urinate
  • muscle twitches and cramps
  • swelling of feet and ankles
  • shortness of breath
  • high blood pressure that is new or difficult to control
  • loss of appetite 
• Lactic acidosis. Tell your doctor right away if you get the following signs or symptoms of lactic acidosis:
  • extreme weakness or tiredness
  • unusual (not normal) muscle pain
  • trouble breathing
  • stomach pain with nausea (upset stomach) and vomiting
  • you feel cold, especially in your arms and legs
  • dizziness or lightheadedness
  • fast or irregular heartbeat
• Liver damage. Tell your doctor right away if you get the following signs or symptoms of liver problems:
  • skin or the white part of your eyes turns yellow (jaundice)
  • urine (pee) turns dark
  • bowel movements (stools) turn light in color
  • you don't feel like eating food for several days or longer
  • you feel sick to your stomach (nausea)
  • you have lower stomach area (abdominal) pain

Do not take Biktarvy if you:

• are allergic to Biktarvy or to any of its ingredients
• take a medication called dofetilide (Tikosyn)
• take a medication called rifampin (Rifadin)

Avoid doing things that can spread HIV infection since Biktarvy does not stop you from passing the HIV infection to others.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Biktarvy, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Biktarvy, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Biktarvy or to any of its ingredients
• take medications that contain dofetilide or rifampin
• have kidney, bone or liver problems (including hepatitis B infection). Be sure and tell your doctor if you are undergoing kidney dialysis treatment
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Biktarvy falls into category B. There are no well-done studies that have been done in humans with Biktarvy. This medication has been evaluated in a limited number of women during pregnancy and postpartum. Human and animal data suggest that Biktarvy does not increase the risk of major birth defects overall. However, there are no well controlled studies in pregnant women. Biktarvy should be during pregnancy only if clearly needed.

If you use Biktarvy while you are pregnant, talk to your doctor about how you can be on the Antiviral Pregnancy Registry.

Tell your doctor if you are breastfeeding. You should not breastfeed if you are HIV-positive because of the chance of passing the HIV virus to your baby.

Also, it is not known if Biktarvy can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.

Take Biktarvy exactly as prescribed. Biktarvy comes in an oral tablet form and is taken once daily with or without food. 

You should take Biktarvy at the same time each day to help you to remember your dose.

If you miss a dose, take it as soon as you remember that day. Do not take 2 doses of Biktarvy in one day. Do not skip doses.

If you stop taking Biktarvy, even for a short time, the amount of virus in your blood may increase. The virus may become harder to treat. 

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose, when used to treat HIV-1 infection in adults, is one tablet (containing 50 mg of bictegravir, 200 mg of emtricitabine and 25 mg of tenofovir alafenamide) once daily taken by mouth, with or without food.

If you take too much Biktarvy, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Store Biktarvy at room temperature and below 86°F (30°C).

Keep Biktarvy in its original container and keep the container tightly closed.

Keep Biktarvy and all medicines out of the reach of children.

Severe acute exacerbations (flare-ups) of hepatitis B have been reported in patients who are coinfected with HIV-1 and hepatitis B virus (HBV) and have discontinued products containing emtricitabine and/or tenofovir, and may occur with discontinuation of Biktarvy. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted.