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Biktarvy (Generic Bictegravir, Emtricitabine, and Tenofovir Alafenamide)

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WARNING

It is not recommended to use bictegravir, emtricitabine, or tenofovir alafenamide (AF) to treat hepatitis B virus infection (HBV; an ongoing liver infection). If you suspect you may have HBV, let your doctor know. Before you start your bictegravir, emtricitabine, and tenofovir medication, your doctor may do a test to determine whether you have HBV. If you are taking bictegravir, emtricitabine, and tenofovir and have HBV, your condition could abruptly go worse if you stop taking them.

Keep all of your appointments with your physician and the lab. Before, throughout, and frequently for several months after you stop taking bictegravir, emtricitabine, and tenofovir, your doctor will check you and do lab tests to see if your HBV has gotten worse.

The risks of taking bictegravir, emtricitabine, and tenofovir should be discussed with your doctor.

Why is this medication prescribed?

Human immunodeficiency virus (HIV) infection is treated with bictegravir, emtricitabine, and tenofovir AF in some adults and kids weighing at least 55 pounds (25 kg) who have not previously received antiretroviral medication or who have remained stable on other antiretroviral treatment (s). Integrase strand transfer inhibitors are a class of drugs that includes bictegravir (INSTIs). Nucleoside reverse transcriptase inhibitors are a class of medicines that includes emtricitabine and tenofovir AF (NRTIs). The interaction of bictegravir, emtricitabine, and tenofovir AF reduces the body’s level of HIV. Although bictegravir, emtricitabine, and tenofovir AF do not treat HIV, they may lessen your risk of contracting AIDS and other diseases linked to the virus, such as serious infections or cancer. The risk of contracting or spreading the HIV virus to others may be reduced by taking these medications, engaging in safer sexual behaviour, and changing other aspects of one’s lifestyle.

How should this medicine be used?

The oral tablet containing bictegravir, emtricitabine, and tenofovir AF is available. The normal dosage is one dose per day, with or without food. Take tenofovir AF, bictegravir, and emtricitabine at roughly the same time each day. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Follow the directions on the label for tenofovir AF, bictegravir, and emtricitabine. Never take it in larger or less amounts or more frequently than directed by your doctor.

Bictegravir, emtricitabine, and tenofovir AF tablets can be divided in half and taken separately as long as they are both taken within 10 minutes of one another if you are unable to swallow the pill whole.

Even if you feel good, keep taking bictegravir, emtricitabine, and tenofovir AF. Without consulting your doctor, do not discontinue taking bictegravir, emtricitabine, or tenofovir AF. It’s possible for the virus to develop drug resistance and become more difficult to treat if you stop taking bictegravir, emtricitabine, and tenofovir AF, even for a little period of time.

For a copy of the manufacturer’s information for the patient, ask your pharmacist or doctor.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking bictegravir, emtricitabine, and tenofovir AF,

  • If you have any allergies, including to bictegravir, emtricitabine, or tenofovir, other drugs, or any of the substances in bictegravir, emtricitabine, and tenofovir AF tablets, inform your doctor right away. Request a list of the components from your pharmacist.
  • Bictegravir, emtricitabine, and tenofovir AF should not be used with some drugs. Before beginning bictegravir, emtricitabine, and tenofovir AF, make sure you and your doctor have reviewed any drugs you are taking or intend to use. Please seek the counsel of your doctor or pharmacist before beginning, stopping, or altering any drugs while taking bictegravir, emtricitabine, and tenofovir AF.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and St. John’s Wort, may interact with bictegravir, emtricitabine, and tenofovir AF. Before beginning treatment with bictegravir, emtricitabine, and tenofovir AF, be sure to inform your doctor and pharmacist that you are taking these drugs. While taking bictegravir, emtricitabine, or tenofovir AF, do not start any of these medications without first talking to your doctor.
  • Take bictegravir, emtricitabine, and tenofovir AF on an empty stomach two hours before you take the antacid or sucralfate if you are taking an antacid that contains calcium, magnesium, aluminium (Maalox, Mylanta, Tums, and others), or sucralfate (Carafate).
  • Bictegravir, emtricitabine, and tenofovir AF should be taken with food at the same time as any iron or calcium supplements you are taking.
  • If you have or have previously had any of the illnesses listed in the IMPORTANT WARNING section, as well as any infection that persists or recurs, such as renal disease or cytomegalovirus (CMV), which is a viral infection that may produce symptoms in persons with weakened immune systems, tell your doctor.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. Call your doctor right away if you become pregnant while taking bictegravir, emtricitabine, or tenofovir. If you have HIV or are taking bictegravir, emtricitabine, or tenofovir, you shouldn’t breastfeed.
  • You should be aware that while you use medications to treat your HIV infection, your immune system could become stronger and start to fight other infections you previously have in your body or trigger the development of other illnesses. You might start to exhibit signs of certain illnesses as a result of this. Tell your doctor right away if you experience any new or worsening symptoms while taking bictegravir, emtricitabine, or tenofovir.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Emtricitabine, tenofovir AF, and bictegravir may all have adverse effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Diarrhea
  • Nausea
  • Vomiting
  • Headache

Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Less urinations
  • Edoema in the ankles and feet
  • Fatigue
  • Breathing difficulty
  • Rapid respiration
  • Rapid or unusual heartbeat
  • Vomiting and nausea in the stomach
  • Hands and feet are a cool or blue colour.
  • Urine that is dark yellow or brown.
  • Colored-light bowel motions
  • Yellowing of the eyes or skin
  • Reduced appetite
  • Weakness
  • Fatigue
  • Feeling unsteady or lightheaded

Other adverse effects could be brought on by bictegravir, emtricitabine, and tenofovir AF. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom). Keep the desiccant pack that is included with the bottle.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

Bictegravir, emtricitabine, and tenofovir AF should always be available. Do not put off getting a refill on your prescription until you are out of medicine.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Biktarvy®
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