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Biktarvy

Generic Name: Bictegravir, Emtricitabine, Tenofovir, Tenofovir bik-TEG’ra-vir, EMtrye-SYE, and ten-of-oh-vir [ten-OF-oh-vir, bik-TEG].
Dosage Forms: Tablet (Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) and (30 mg/emtricitabine 120 mg/tenofovir alafenamide 15mg).
Drug Class: Antiviral combinations.

The Active Ingredients: Emtricitabine, bictegravir, and Tenofovir alafenamide.

The Inactive Components:  Magnesium stearate, croscarmellose sodium, and microcrystalline cellulose.

What is Biktarvy?

Biktarvy is an all-inclusive HIV-1 treatment available in a single tablet that contains three antiviral medications, namely bictegravir, emtricitabine, and tenofovir. Biktarvy is effective in preventing HIV from multiplying within the body. It also lowers HIV plasma levels, which reduces your risk of getting AIDS as well as HIV-related illnesses such as cancer and serious infections. Biktarvy isn't an effective treatment for HIV. Human immunodeficiency virus 1 (HIV-1) is the principal virus responsible for causing the acquired immunodeficiency syndrome (AIDS).

Biktarvy includes three antiviral drugs that stop viruses from replicating and thus reduce the number of infections in your body. Bictegravir is part of a group of drugs known as integrase strand transfer inhibitors (INSTIs). Emtricitabine as well as tenofovir and alafenamide belong to the category of medicines known as nucleoside reverse transcriptionase inhibitors (NRTIs). Bictegravir, as well as emtricitabine and tenofovir, are antiviral medications that stop this HIV virus from spreading. Biktarvy is an FDA-approved drug that is used as a complete treatment to treat HIV-1 infections in children and adults who weigh between 14 and 14 kilograms. Bikarvy is a treatment option for patients who have not previously taken HIV-1 medication in the past or to substitute their current medication in the case of:

  • Viral suppression (HIV-1 RNA less than 50 copies per milliliter) was achieved.
  • In a stable antiretroviral regimen that has no evidence of treatment failure.
  • There are no known substitutions related to resistance to the elements in Biiktarvy (bictegravir, emtricitabine, and tenofovir).

Warnings

The onset of the hepatitis B virus (HBV) infection

Your doctor will check you for HBV infection prior to or at the time you begin treatment with this medication. If you suffer from HBV and you are taking Biktarvy, your HBV could become worse (called a "flare-up") in the event that you quit taking Biktarvy. The term "flare-up" refers to when your HBV infection becomes more severe than it was before. Do not run out of Biktarvy. You must refill your prescription or speak to your doctor before Biktarvy is gone. Stop taking the medication without consulting your healthcare professional.

If you decide to stop taking this medication and your doctor is notified, they will have to monitor your health frequently and conduct routine blood tests over the course of several months to assess your liver. He may have to prescribe you a drug to treat the infection known as hepatitis B. Inform your doctor of any unusual or new symptoms that you experience when you stop taking this medication.

Before you take this drug

You shouldn't make use of Biktarvy in the event that you are allergic to antiviral medications like bictegravir, tenofovir, or emtricitabine that are found in medications like Atripla, Complera, Emtriva, Descovy, Genvoya, Odefsey, Stribild, or Truvada. Certain medications can trigger unwanted or harmful effects when taken in conjunction with Biktarvy or other medicines, and your physician might need to alter the treatment regimen. Avoid taking Biktarvy when you are also taking medicines that contain:

  • Dofetilide.

  • Rifampin.

Inform your doctor if you were or have had

  • The liver condition (especially cirrhosis).
  • Hepatitis B virus (HBV).
  • Kidney disease.

Pregnancy: Contact your healthcare provider if you are expecting or planning to become pregnant during treatment with Biktarvy. It is not clear whether Biktarvy may cause harm to your baby. There is a registry for pregnant women who are taking the medicine during the course of pregnancy. The goal of this registry is to gather data about the health status of you and your child. Consult your doctor about ways to participate in this registry. You shouldn't breastfeed while taking Biktarvy.

  • It is not recommended to give birth to a baby if you are living with HIV-1 due to the possibility of transmitting HIV-1 to a child.
  • At the very least, one of the medicines found in Bikatrvy could be passed on to your baby through your breast milk. It's not clear which other medicines contained in Biktarvy are absorbed into breast milk.

Consult your healthcare professional regarding the best method to feed your child.

How to take Biktarvy?

You should take Biktarvy exactly as directed by your physician. Follow the instructions on your prescription label and review all medication guides or instruction sheets. Follow the medication exactly as prescribed.

Biktarvy is an HIV-1 treatment that is complete. It is recommended not to combine it with other HIV-1 medications.

  • Consume one Biktarvy tablet every day, whether or not you eat.
  • If you're not able to swallow the entire tablet, it is possible to break the tablet in two and eat each piece in its own way, so long as each part is swallowed within around 10 minutes.
  • Do not alter the dosage or cease taking this medication without consulting your doctor. Keep under the supervision of a healthcare professional during treatment with this medication.
  • If you are taking antacids or supplements containing iron or calcium, take Biktarvy with food at the same time that you are taking supplements or antacids.
  • If you are taking antacids that comprise aluminum and magnesium, you should use Biktarvy at least 2 hours prior to or for 6 hours after taking these anti-acids.
  • If you are taking dialysis, you should take your dose of Biktarvy every day after dialysis.
  • If your medication supply begins to deplete, seek more from your physician or pharmacist to ensure that you don't get depleted. This is crucial since if the medication is removed for any length of time, the amount of virus in your blood could rise, and the virus may become resistant to Biktarvy and make it more difficult to manage.
  • You'll require regular medical tests.
  • Don't skip the chance to take a dose of Biktarvy.

Details on dosage

The usual dose of HIV infection for children and adults with a weight of at least 25 kg is:

  • Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25,25 mg) is 1 tablet once per day, either with or without meals.

The usual dose to treat HIV infection in children with a weight of at least 14 kg to less than 25 kg is:

  • Biktarvy (bictegravir 30 mg, emtricitabine 120 mg, and tenofovir afenamide 15mg): 1 tablet a day, either with or without meals.

Comments: For children who weigh between 14 and less than 25 kilograms and cannot swallow the entire tablet The tablet is able to be split, and each piece is able to be eaten separately so long as they are taken in about 10 minutes.

What happens if I miss a dose?

Use the medicine as quickly as you are able, but take a break from your missed dose if it's nearing the time to take the next dose. Don't try to take two doses at the same time..

What happens if I overdose?

For medical emergencies, seek emergency medical attention or contact the Poison Help line at 1-800-222-1222.

Adverse effects of Biktarvy

See a doctor immediately. If you are experiencing symptoms that you are experiencing an allergic reaction, Biktarvy: hives, breathing difficulties, or swelling of your lips, face, and tongue.

Severe Biktarvy adverse effects are:

Kidney issues: New or worse kidney problems, which can include kidney failure. Your doctor should arrange urine and blood tests to examine your kidneys prior to and while you are taking this medication. If you have more severe or new kidney problems, the doctor may advise you to quit taking this medicine. The signs of kidney issues include:

  • Very little or no urination.
  • Swelling in your ankles or feet.
  • Feeling tired.
  • Breathlessness.

Changes to your body's immune system (Immune Reconstitution Syndrome): This could happen as you begin to take HIV-1 medications. Your immune system could become stronger and start fighting infections that have been hiding within your body for a long time. Inform your doctor immediately if you begin developing any new symptoms after the start of your HIV-1 treatment.

Liver problems that are severe. In rare cases, severe liver problems could occur that could lead to death. Inform your doctor immediately if you notice these signs:

  • The skin or the white portion of your eyes turns yellow.
  • Darker "tea-colored" urine.
  • Light-colored stools.
  • Lack of appetite for several days or more.
  • Nausea.
  • Stomach-area pain.

Too much lactic acid in your blood (lactic acidosis) The presence of too much lactic acid can be a serious but very rare emergency medical condition that may cause death. Contact your physician immediately if you notice these signs:

  • In fatigue or having more fatigue than normal.
  • Unusual muscle pain.
  • Having trouble breathing or breathing fast.
  • Stomach pain, nausea, and vomiting.
  • Hands or feet.
  • Feel lightheaded or dizzy.
  • A heartbeat that is fast or irregular.

The most frequent Biktarvy adverse effects are:

  • Diarrhea.

  • Nausea.

  • Headache.

This isn't a complete list of all the side effects. Others could happen. Speak to your doctor, pharmacist, or healthcare professional for medical advice on the effects of adverse effects. You can report adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with other drugs

It is sometimes not recommended to take certain medications in conjunction with Biktarvy. The effects of certain drugs may affect your blood levels and the effects of other drugs you are taking, which could cause more side effects or make Biktarvy less effective.

It is recommended that you not use Biktarvy along with

  • Dofetilide
  • Refampin.

The following are not recommended: It is not advised to use Biktarvy in conjunction with:

  • Rifabutin.
  • Rifapentine.
  • John's wort.

If you are taking Biktarvy, alternative anticonvulsants are recommended instead of:

  • Carbamazepine.
  • Oxcarbazepine.
  • Phenobarbital.
  • Phenytoin.

Numerous drugs can interfere with Biktarvy. This includes prescription and over-the-counter medications, vitamins, and herbal remedies. Interactions of all kinds are not mentioned in this list. Be sure to inform your doctor about all your current medications and any medications you begin or stop taking. To determine if there are any drug-related interactions with Biktarvy, go to this link.

Storage

  • Keep the Biktarvy tablets in their original bottle at a temperature of 86 degrees (30 degrees Celsius).
  • Make sure the bottle is tightly sealed.
  • This medicine comes with a desiccant package to keep your medication in a dry state (protect your medicine against moisture). Place the desiccant pack inside the bottle. Avoid eating the desiccant package.
  • Keep the Biktarvy blister packet at room temperature between 68 and 77 degrees Fahrenheit (20 degrees Celsius to 20 degrees Celsius).
  • Be sure to keep Biktarvy in the original bottle or in a blister pack.
  • Biktarvy is packaged in child-proof packaging.
DRUG STATUS

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Prescription only

Pregnancy & Lactation

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