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HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
This combination product is used by itself to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. This product is a combination of 3 different drugs: bictegravir, emtricitabine, and tenofovir alafenamide. Bictegravir is called an integrase strand transfer inhibitor-INSTI. Emtricitabine is called a nucleoside reverse transcriptase inhibitor, while tenofovir alafenamide is called a nucleotide reverse transcriptase inhibitor.
Emtricitabine and tenofovir alafenamide are often called NRTIs. Bictegravir/emtricitabine/tenofovir alafenamide is not a cure for HIV infection.
To decrease your risk of spreading HIV disease to others, do all of the following:
(1) continue to take all HIV medications exactly as prescribed by your doctor,
(2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and
(3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.
Read the Patient Information Leaflet if available from your pharmacist before you start taking bictegravir/emtricitabine/tenofovir alafenamide and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually once daily with or without food. If you are also taking antacids that contain aluminum, magnesium, or calcium, take this medication on an empty stomach 2 hours before you take these antacids. If you are taking iron or calcium supplements, take them with food at the same time that you take this medication.
Ask your doctor or pharmacist if you have any questions. It is very important to keep taking this medication exactly as prescribed by your doctor. Do not skip any doses. For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day. Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.
Diarrhea, nausea, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine, pink/bloody urine), signs of liver problems (such as nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of a certain metabolism disorder-lactic acidosis (such as unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, or stomach pain with nausea/vomiting/diarrhea).
As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including: unexplained weight loss, severe tiredness, muscle aches/weakness that doesn’t go away, headaches that are severe or don’t go away, joint pain, numbness/tingling of the hands/feet/arms/legs, vision changes, signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores), signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter), signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this product, tell your doctor or pharmacist if you are allergic to bictegravir, emtricitabine, or tenofovir; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems (hepatitis B, hepatitis C, cirrhosis), alcohol use, kidney disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and this medication may be part of that treatment. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.
See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval. Some products that may interact with this drug are: orlistat, other drugs that may harm the kidneys (including adefovir, cidofovir, aminoglycosides such as amikacin/gentamicin).
Other medications can affect the removal of this medication from your body, which may affect how it works. Examples include rifamycins (such as rifampin, rifabutin), St. John’s wort, drugs used to treat seizures (such as barbiturates, carbamazepine, phenytoin), among others. This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include dofetilide, among others. Do not take this medication with other products that treat HIV infection. Do not take this medication with other products that contain bictegravir, emtricitabine, or tenofovir.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others. Lab and/or medical tests (such as kidney/liver function, viral load, T-cell counts, tests for hepatitis B) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE – ORAL