This combination medication contains three medications in one tablet: bictegravir, emtricitabine, and tenofovir alafenamide. Together, these medications are antiretroviral medications.

This medication is used by adults and children who weigh at least 25 kg to treat human immunodeficiency virus (HIV) infection. This product should not be used in combination with any other product to treat HIV infection.

Bictegravir is an integrase strand transfer inhibitor (INSTI). Integrase is an enzyme that is needed for the HIV virus to be reproduced. INSTIs stop the action of this enzyme, blocking the virus from reproducing.

Emtricitabine and tenofovir both belong to the class of antiretrovirals called nucleoside analog reverse transcriptase inhibitors (NRTIs). Reverse transcriptase is an enzyme that needed by HIV to multiply and infect other cells. These two medications prevent reverse transcriptase from working properly.

Antiretroviral medications work by interfering with enzymes that are needed for HIV to multiply, thus lowering the amount of HIV in the blood. They may also help the immune system by increasing the number of CD4 (T) cells in the body.

This medication does not cure HIV infection or AIDS and does not reduce the risk of passing HIV to others through sexual contact or blood contamination.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended dose of bictegravir-emtricitabine-tenofovir is 1 tablet taken by mouth, once daily. This medication may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is less than 6 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in its original container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Each purplish-brown, capsule-shaped, film-coated tablet, debossed with "GSI" on one side and "9883" on the other side, contains 50 mg of bictegravir (equivalent to 52.5 mg of bictegravir sodium), 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide (equivalent to 28.0 mg of tenofovir alafenamide hemifumarate). Nonmedicinal ingredients: microcrystalline cellulose, croscarmellose sodium, and magnesium stearate; film-coating: iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Do not take this medication if you:

• are allergic to bictegravir, emtricitabine, tenofovir or any ingredients of the medication
• are taking dofetilide, rifampin, or St. John's wort

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• abnormal dreams
• diarrhea
• dizziness
• gas
• headache
• heartburn
• nausea
• rash
• tiredness
• trouble sleeping

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• signs of autoimmune disorders (e.g., muscle weakness, tremor, pounding heartbeat, weakness in the extremities moving toward the trunk of the body)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of hepatitis B flare-ups (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual tiredness, dizziness, rapid heart rate)
• signs of a severe skin reaction (e.g., blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort)
• thoughts of suicide

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Cholesterol: Blood cholesterol levels may increase during HIV treatment. If you are at risk of developing high cholesterol or you have high cholesterol levels before starting this medication, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diabetes: This medication may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Hepatitis B: For patients with hepatitis B, your doctor will talk to you about HIV treatment before you begin taking this medication. The safety and effectiveness of taking this medication if you have both HIV and hepatitis B have not been determined. People with hepatitis B who have taken emtricitabine or tenofovir (two of the medications in this product) have experienced severe recurrences of hepatitis B when the emtricitabine or tenofovir have been stopped.

Immune reconstitution inflammatory syndrome: This medication may cause immune reconstitution inflammatory syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or tuberculosis). Autoimmune disorders have been reported to develop as a result of immune reconstitution inflammatory syndrome. These conditions can affect the thyroid, digestive system, muscles, or joints. Report any new symptoms to your doctor immediately.

Kidney function: This medication may cause changes in kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Lactic acidosis and enlarged liver: This medication can cause a rare but serious condition called lactic acidosis (buildup of lactic acid), together with an enlarged fatty liver. Your doctor will periodically monitor you and perform laboratory tests to check your liver function. If you notice any symptoms of this condition such as nausea, vomiting, stomach pain, weakness, tiredness, feeling cold, dizziness, lightheadedness, or irregular heartbeat, seek immediate medical attention.

Liver problems: If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may monitor your liver function while you are taking this medication, especially if you have risk factors for liver problems. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if bictegravir or tenofovir alafenamide passes into breast milk. Emtricitabine passes into breast milk and may affect your baby. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using this medication have not been established for children who weigh less than 25 kg.

There may be an interaction between bictegravir-emtricitabine-tenofovir alafenamide and any of the following:

• acyclovir
• adefovir
• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
• apalutamide
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• cabozantinib
• calcium supplements (e.g., calcium carbonate, calcium citrate)
• carbamazepine
• ceritinib
• cidofovir
• cladribine
• clarithromycin
• cobicistat
• enzalutamide
• HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
• ganciclovir
• idelalisib
• iron supplements (e.g., ferrous gluconate, ferrous sulfate)
• lumacaftor and ivacaftor
• metformin
• mifepristone
• mitotane
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
• orlistat
• oxcarbazepine
• phenobarbital
• phenytoin
• primidone
• rifabutin
• rifampin
• St. John's wort
• sofosbuvir
• sucralfate
• valacyclovir
• valganciclovir

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.