Bictegravir, Emtricitabine, and Tenofovir : Uses, Side Effects, Interactions & More

The combination of bictegravir, emtricitabine, and tenofovir is used to treat human immunodeficiency virus (HIV) infection in certain adults and children who weigh at least 55 pounds (25 kg) who have not received antiretroviral treatment in the past or who have been stable with other antiretroviral treatment (s). Bictegravir is in a class of drugs called integrase chain transfer inhibitors (INSTIs). Emtricitabine and tenofovir belong to a class of drugs called nucleoside analog reverse transcriptase inhibitors (NRTIs). The combination of bictegravir, emtricitabine, and tenofovir works by lowering the amount of HIV in the body. Although bictegravir, emtricitabine, and tenofovir will not cure HIV, these medications can lower your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses, such as serious infections or cancer. Taking these medications along with safer sex and making other lifestyle changes can lower your risk of getting or passing the HIV virus to others.

The combination of bictegravir, emtricitabine, and tenofovir comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take bictegravir, emtricitabine, and tenofovir at around the same times every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Take bictegravir, emtricitabine, and tenofovir exactly as directed. Do not take more or less, or take it more often than prescribed by your doctor.

Keep taking bictegravir, emtricitabine, and tenofovir even if you feel fine. Do not stop taking bictegravir, emtricitabine, and tenofovir without talking to your doctor. If you stop taking bictegravir, emtricitabine, and tenofovir even for a short time, or skip doses, the virus may become resistant to the drugs and may be more difficult to treat.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

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

Before taking bictegravir, emtricitabine, and tenofovir,

• Tell your doctor and pharmacist if you are allergic to bictegravir, emtricitabine, and tenofovir, any other medications, or any of the ingredients in bictegravir, emtricitabine, and tenofovir tablets. Ask your pharmacist for a list of the ingredients.
• Tell your doctor if you are taking dofetilide (Tikosyn) or rifampin (Rifadin, Rimactane, in Rifamate, in Rifater). Your doctor will probably tell you not to take bictegravir, emtricitabine, and tenofovir if you are taking any of these medications.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acyclovir (Zovirax); carbamazepine (Carbatrol, Epitol, Equetro, Tegretol, Teril); cidofovir; ganciclovir (Valcyte); gentamicin; other medicines to treat human immunodeficiency virus (HIV); metformin (Glucophage, Riomet); nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); Oxcarbazepine (Trileptal); phenobarbital; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifapentine (Priftin); ritonavir (Norvir, in Kaletra); valacyclovir (Valtrex); and valganciclovir (Valcyte). Your doctor may need to change the doses of your medications or monitor you closely for side effects. Many other medications can also interact with bictegravir, emtricitabine, and tenofovir, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• If you are taking an antacid that contains calcium, magnesium, aluminum (Maalox, Mylanta, Tums, others), or sucralfate (Carafate), take bictegravir, emtricitabine, and tenofovir on an empty stomach 2 hours before you take the antacid or sucralfate.
• If you are taking an iron or calcium supplement, take it at the same time as bictegravir, emtricitabine, and tenofovir with food.
• Tell your doctor what herbal products you are taking, especially St. John’s wort.
• Tell your doctor if you have or have ever had the conditions mentioned in the IMPORTANT WARNING section or any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; an infection virus that can cause symptoms in people with weak immune systems) or kidney disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking bictegravir, emtricitabine, and tenofovir, call your doctor. You should not breastfeed if you are infected with HIV or if you are taking bictegravir, emtricitabine, and tenofovir.
• You should know that while you are taking medicine to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This can cause you to develop symptoms of these infections or conditions. If you have new or worsening symptoms during your treatment with bictegravir, emtricitabine, and tenofovir, be sure to tell your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one.

Bictegravir, emtricitabine, and tenofovir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• headache

If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• decreased urination
• swelling of feet and ankles
• fatigue
• shortness of breath
• fast breathing
• fast or abnormal heartbeat
• stomach pain with nausea and vomiting
• cold or blue color of the hands and feet
• dark yellow or brown urine
• light-colored bowel movements
• yellowing of skin or eyes
• loss of appetite
• weakness
• fatigue
• dizziness or lightheadedness

Bictegravir, emtricitabine, and tenofovir can cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medicine in the container it came in, tightly closed, and out of the reach of children. Store at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medicines out of the sight and reach of children, as many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not child-resistant and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

Unnecessary medications must be disposed of in special ways to ensure they cannot be consumed by pets, children, and others. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to learn about take-back programs in your community. Check out the FDA drug safe disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, is having trouble breathing, or is unable to wake up, immediately call 911 for emergency services.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

Have a supply of bictegravir, emtricitabine, and tenofovir on hand. Don’t wait until your medicine runs out to get a refill.

It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you every time you visit a doctor or if you go into hospital. It is also important information to take with you in case of emergencies.