BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

PHONETIC PRONUNCIATION: (bik-TEG-ra-vir/EM-trye-SYE-ta-been/ten-OF-oh-vir AL-a-FEN-a-mide)

COMMON BRAND NAME(S): Biktarvy

GENERIC NAME(S): bictegravir sodium/emtricitabine/tenofovir alafenamide fumar

Uses

USES: 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.


How to use BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

HOW TO USE: 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.

Side Effects

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.

Precautions

PRECAUTIONS: 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.

Interactions

DRUG INTERACTIONS: 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.

Overdose

OVERDOSE: 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.

Images

BIKTARVY 50-200-25 MG TABLET

color
brown
shape
oblong
imprint
GSI, 9883

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Faq for BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE - ORAL

BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE is a medication used to treat HIV-1 infection in adults who have not previously received HIV treatment.

BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE is a combination of three different antiviral medications. BICTEGRAVIR is an integrase strand transfer inhibitor that prevents the virus from multiplying. EMTRICITABINE and TENOFOVIR ALAFENAMIDE are nucleoside reverse transcriptase inhibitors that block the enzyme necessary for HIV replication.

Common side effects may include headache, nausea, diarrhea, tiredness, and dizziness. It is important to inform your healthcare provider if you experience any unusual or severe side effects.

BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE is usually taken once daily with or without food. It is important to follow the instructions provided by your healthcare provider and take the medication regularly as prescribed.

Yes, BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE may interact with other medications, including over-the-counter drugs, herbal supplements, and prescription medications. It is important to inform your healthcare provider about all the medications you are taking to avoid potential interactions.

This medication may be used during pregnancy if the potential benefits outweigh the risks. It is important to discuss the risks and benefits with your healthcare provider.

It is not recommended to breastfeed while taking BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE. Breastfeeding can transmit HIV to the baby, and alternative feeding options should be considered.

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

The medication starts to work as soon as it is absorbed into the body, but it may take several weeks for the viral load to decrease and the immune system to improve. It is important to continue taking the medication as directed by your healthcare provider.

BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE is a combination medication used to treat HIV-1 infection in adults who have not been previously treated with HIV-1 medicines.

You should inform your healthcare provider about any medical conditions you have, including liver problems, kidney problems, or bone problems. It is also essential to disclose all other medications and supplements you are currently taking to avoid potential drug interactions.

BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE is usually taken as one tablet once daily, with or without food. It is important to take the medication consistently as prescribed by your healthcare provider.

While rare, BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE can cause serious side effects such as liver problems, kidney problems, and a buildup of lactic acid in the blood (lactic acidosis). Contact your healthcare provider immediately if you experience symptoms such as yellowing of the skin or eyes, dark urine, abdominal pain, or muscle pain.

If you are pregnant or planning to become pregnant, you should discuss with your healthcare provider the potential benefits and risks of taking this medication. It is essential to use effective contraception if you are of childbearing potential during treatment.

BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE can interact with other medications, including antacids, antibiotics, and certain antiviral drugs. It is crucial to inform your healthcare provider about all medications you are taking to avoid potential interactions.

The duration of treatment with BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE will be determined by your healthcare provider. It is generally taken on a long-term basis to effectively control HIV infection. Do not stop taking the medication without consulting your healthcare provider.


Warning

WARNING: If you have hepatitis B infection as well as HIV, your hepatitis symptoms may get worse or become very serious if you stop taking this medication. Talk with your doctor before stopping this medication. Your doctor will check your liver function tests for several months after you stop. Tell your doctor right away if you develop symptoms of worsening liver problems.


Disclaimer

IMPORTANT: 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.