Pronunciation:

bik-TEG-ra-vir, em-trye-SYE-ta-been, ten-OF-oh-vir al-a-FEN-a-mide

Brand Names:

• Biktarvy

Dosage Forms:

• Tablet

Warnings:

Warning: Post treatment acute exacerbation of hepatitis BSevere acute exacerbations 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 (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of bictegravir/emtricitabine/tenofovir alafenamide.Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue bictegravir/emtricitabine/tenofovir alafenamide. If appropriate, anti-hepatitis B therapy may be warranted .

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Integrase Inhibitor

Uses of This Medicine:

Bictegravir, emtricitabine, and tenofovir alafenamide combination is used alone to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients who have yet to receive any medicine for their HIV infection or to patients to replace their current medicine provided that they meet certain requirements.

Bictegravir, emtricitabine, and tenofovir alafenamide combination will not cure or prevent HIV infection or AIDS. It works by lowering the amount of HIV in the blood and will also help your immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. This medicine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bictegravir, emtricitabine, and tenofovir alafenamide combination in children weighing less than 14 kilograms (kg). Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bictegravir, emtricitabine, and tenofovir alafenamide combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine
• Dofetilide
• Fosphenytoin
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• St John's Wort

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Aceclofenac
• Acemetacin
• Acyclovir
• Adagrasib
• Aluminum
• Amikacin
• Amikacin Liposome
• Amiodarone
• Amtolmetin Guacil
• Apalutamide
• Aspirin
• Bromfenac
• Bufexamac
• Cabotegravir
• Calcium
• Capmatinib
• Capreomycin
• Carbamazepine
• Carvedilol
• Celecoxib
• Choline Salicylate
• Cidofovir
• Clarithromycin
• Clonazepam
• Clonixin
• Cobicistat
• Conivaptan
• Cyclosporine
• Darolutamide
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Dronedarone
• Droxicam
• Enasidenib
• Encorafenib
• Enzalutamide
• Erythromycin
• Eslicarbazepine Acetate
• Etodolac
• Etofenamate
• Etoricoxib
• Fedratinib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Flibanserin
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fosphenytoin
• Ganciclovir
• Gentamicin
• Horsetail
• Ibuprofen
• Indomethacin
• Iron
• Itraconazole
• Kanamycin
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Leflunomide
• Leniolisib
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Magaldrate
• Magnesium
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Midostaurin
• Mitotane
• Momelotinib
• Morniflumate
• Nabumetone
• Naproxen
• Neomycin
• Nepafenac
• Netilmicin
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Omaveloxolone
• Orlistat
• Oxaprozin
• Oxcarbazepine
• Oxyphenbutazone
• Parecoxib
• Paromomycin
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piroxicam
• Plazomicin
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Quinidine
• Ranolazine
• Rifabutin
• Rifapentine
• Ritonavir
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Spectinomycin
• St John's Wort
• Streptomycin
• Sucralfate
• Sulindac
• Tacrolimus
• Tafamidis
• Telaprevir
• Tenoxicam
• Teriflunomide
• Tiaprofenic Acid
• Tipranavir
• Tobramycin
• Tolfenamic Acid
• Tolmetin
• Valacyclovir
• Valdecoxib
• Valganciclovir
• Vemurafenib
• Verapamil
• Zinc

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Eltrombopag

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Chronic kidney disease or
• Fanconi syndrome (kidney disease), history of or
• Hepatitis B infection, history of or
• Kidney failure, history of—Use with caution. May make these conditions worse.

• Kidney disease (eg, end-stage kidney disease, patients receiving dialysis), severe or
• Liver disease, severe—Use is not recommended in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully.

You may take this medicine with or without food.

Children who are not able to swallow a whole tablet may cut the medicine in half and take each part separately within 10 minutes.

Take this medicine at least 2 hours before or 6 hours after taking an antacid that contains aluminum or magnesium.

You may take an antacid or supplement containing calcium or iron together with this medicine if you take them with food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults and children weighing 25 kilograms (kg) or more—One tablet once a day. Each tablet contains 50 milligrams (mg) bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide.
    • Children 14 kg to less than 25 kg—One tablet once a day. Each tablet contains 30 mg bictegravir, 120 mg emtricitabine, and 15 mg tenofovir alafenamide.
    • Children weighing less than 14 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the bottle tightly closed. Keep the medicine in its original container.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits, especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for any unwanted effects.

Do not use this medicine together with dofetilide (Tikosyn®) or rifampin (Rifadin®, Rimactane®). Using these medicines together may cause serious or life-threatening side effects.

This medicine may cause a hepatitis B infection to worsen if you stop using it. Your doctor may check for the presence of hepatitis B before and during treatment with this medicine and for at least several months after your last dose.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, including pneumonia, herpes, or tuberculosis. Autoimmune disorders (eg, Graves' disease, polymyositis, and Guillain-Barré syndrome) may also occur.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Two rare but serious reactions to this medicine are lactic acidosis (too much acid in the blood) and liver toxicity, which includes an enlarged liver. Call your doctor right away if you have dark urine, decreased appetite, diarrhea, general feeling of discomfort, light-colored stools, muscle cramping or pain, nausea, stomach discomfort or cramping, unusual tiredness or weakness, trouble breathing, vomiting, or yellow eyes or skin.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Stomach pain

Rare

Changes in behavior

thoughts or attempts of killing oneself

Incidence not known

Blistering, peeling, or loosening of the skin

bloody or cloudy urine

chills

confusion

cough

dark urine

decreased appetite

decreased frequency or amount of urine

diarrhea

difficult or painful urination

fast, shallow breathing

general feeling of discomfort

hives or welts, itching, skin rash

increased blood pressure

increased thirst

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

lower back or side pain

muscle pain or cramps

nausea

rapid weight gain

red irritated eyes

red skin lesions, often with a purple center

right upper abdominal or stomach pain and fullness

sleepiness

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stomach discomfort

sudden decrease in the amount of urine

swelling of the face, fingers, or lower legs

trouble breathing

unusual tiredness or weakness

vomiting

weight gain

yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Abnormal dreams

belching

bloated feeling

discouragement

dizziness

excess air or gas in the stomach or bowels

feeling of fullness

feeling sad or empty

headache

heartburn

indigestion

irritability

loss of interest or pleasure

passing gas

stomach upset

trouble concentrating

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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