Biktarvy 120/30/15mg Tablets

Bictegravir is an integrase strand transfer inhibitor (INSTI) that inhibits HIV-1 integrase, an enzyme essential for viral replication, by blocking the strand transfer step of retroviral DNA integration. Emtricitabine (FTC) and Tenofovir Alafenamide (TAF) are nucleoside reverse transcriptase inhibitors (NRTIs). FTC is a synthetic nucleoside analog of cytidine. TAF is a phosphonamidate prodrug of tenofovir. Both are phosphorylated intracellularly to their active triphosphate forms (FTC-TP and tenofovir diphosphate, respectively). These active metabolites inhibit HIV-1 reverse transcriptase by competing with natural deoxyribonucleoside substrates and by incorporation into viral DNA, leading to chain termination.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of liver problems, such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of lactic acidosis (too much lactic acid in the blood), including:
+ Rapid breathing
+ Rapid heartbeat
+ Abnormal heartbeat
+ Severe upset stomach or vomiting
+ Extreme drowsiness
+ Shortness of breath
+ Feeling very tired or weak
+ Severe dizziness
+ Feeling cold
+ Muscle pain or cramps
New or worsening behavioral or mood changes, such as depression or suicidal thoughts

Changes in Your Immune System

When starting HIV treatment, your immune system may respond in unexpected ways. If you have an underlying infection, it may become apparent after beginning treatment. Inform your doctor immediately if you experience any new symptoms, even if they appear after several months of treatment. These symptoms may include:

Signs of infection, such as:
+ Fever
+ Sore throat
+ Weakness
+ Cough
+ Shortness of breath

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or persist, contact your doctor:

Diarrhea
Upset stomach
* Headache

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
Existing health conditions, including kidney disease or liver disease.
Current medications, particularly:
+ Carbamazepine
+ Dofetilide
+ Oxcarbazepine
+ Phenobarbital
+ Phenytoin
+ Rifabutin
+ Rifampin
+ Rifapentine
+ St. John's wort
+ Other HIV treatments
+ Medications that may increase the risk of kidney problems (your doctor or pharmacist can help you identify these)
Pregnancy, planned pregnancy, or breastfeeding status. Discuss the benefits and risks of this medication with your doctor, as well as the best methods for preventing mother-to-child transmission of HIV.

Please note that this is not an exhaustive list of potential interactions. This medication can interact with numerous other drugs, which may increase the risk of severe, life-threatening, or fatal side effects. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Verify that it is safe to take this medication with your existing medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Your doctor will instruct you on when to undergo hepatitis B testing, so be sure to follow their guidance and discuss any concerns with them.

Regular blood work and laboratory tests are crucial while taking this drug. Adhere to the schedule recommended by your doctor to ensure your health is closely monitored.

Although this medication helps manage HIV, it is not a cure. Continue taking it exactly as prescribed by your doctor or healthcare provider, even if you feel well. Regular appointments with your doctor are vital to maintain proper care.

This drug works by reducing the amount of HIV in your blood. By lowering the viral load to undetectable levels, you can significantly decrease the risk of transmitting HIV to others. However, it is crucial to combine this treatment with other preventive measures, such as using condoms during sexual intercourse and avoiding the sharing of needles and other injection equipment. Consult your doctor or healthcare provider to discuss the most effective strategies for preventing the spread of HIV.

Be aware that kidney problems, including kidney failure, have been associated with this medication. If you have a history of kidney issues, inform your doctor promptly.

In rare instances, this drug can cause severe side effects, including liver swelling and a buildup of acid in the blood, which can be life-threatening. The risk of these adverse effects may be higher in women, overweight individuals, and those who have taken similar medications for an extended period.

• Dofetilide (risk of increased dofetilide concentrations and life-threatening arrhythmias)
• Rifampin (strong CYP3A and UGT1A1 inducer, significantly decreases bictegravir concentrations, leading to loss of virologic response)

• Carbamazepine, Oxcarbazepine, Phenobarbital, Phenytoin (strong CYP3A/UGT1A1 inducers, may decrease bictegravir concentrations)
• Rifabutin, Rifapentine (moderate CYP3A/UGT1A1 inducers, may decrease bictegravir concentrations; coadministration not recommended)
• St. John's Wort (strong CYP3A/UGT1A1 inducer, may decrease bictegravir concentrations)
• Dronedarone (may increase tenofovir concentrations)
• Aminoglycosides, high-dose or multiple NSAIDs, cisplatin, cidofovir, foscarnet, ganciclovir, valacyclovir, valganciclovir (nephrotoxic agents, may increase tenofovir concentrations and risk of renal adverse reactions)

• Antacids containing aluminum, magnesium, or calcium (e.g., Tums, Maalox, Mylanta): Separate administration by at least 2 hours before or 6 hours after Biktarvy. If taken with food, can be taken at the same time.
• Oral iron supplements or calcium supplements (e.g., ferrous fumarate, calcium carbonate): Separate administration by at least 2 hours before or 6 hours after Biktarvy. If taken with food, can be taken at the same time.
• Metformin (TAF may increase metformin concentrations; monitor for metformin-related adverse reactions)
• Ledipasvir/Sofosbuvir, Sofosbuvir/Velpatasvir, Sofosbuvir/Velpatasvir/Voxilaprevir (may increase tenofovir concentrations; monitor for tenofovir-associated adverse reactions)

• No clinically significant minor interactions requiring specific dose adjustments or monitoring are typically highlighted for Biktarvy.

• Signs and symptoms of acute exacerbation of hepatitis B (if co-infected and treatment is discontinued): fatigue, dark urine, yellowing of skin/eyes, abdominal pain.
• Signs and symptoms of renal dysfunction: decreased urine output, swelling in legs/feet, fatigue.
• Signs and symptoms of liver dysfunction: nausea, vomiting, abdominal pain, dark urine, jaundice.
• Signs and symptoms of lactic acidosis (rare but serious): unexplained muscle pain, weakness, difficulty breathing, abdominal pain, nausea, vomiting, cold/blue extremities, dizziness, irregular heartbeat.
• Signs and symptoms of immune reconstitution inflammatory syndrome (IRIS): worsening of pre-existing or new opportunistic infections/inflammatory conditions after starting ART.

Biktarvy is generally considered acceptable for use during pregnancy based on available data from the Antiretroviral Pregnancy Registry and clinical experience. The benefits of maintaining viral suppression in pregnant individuals with HIV-1 outweigh potential risks. Discuss with a healthcare provider.

Breastfeeding is not recommended for mothers with HIV-1 infection in the U.S. to avoid postnatal transmission of HIV-1 to the infant. Additionally, components of Biktarvy are excreted in human milk, and the effects on breastfed infants are unknown. The Centers for Disease Control and Prevention (CDC) recommends against breastfeeding by HIV-infected mothers.

Approved for pediatric patients weighing at least 25 kg. Dosing is one tablet (bictegravir 50 mg, emtricitabine 200 mg, and tenofovir alafenamide 25 mg) orally once daily. Safety and efficacy have been established in this population.

No specific dose adjustment is required for elderly patients. However, age-related decline in renal function should be considered, and renal function should be monitored closely in this population.

• Biktarvy is a complete regimen, meaning it contains all necessary components for HIV-1 treatment in one pill, simplifying adherence.
• It is generally well-tolerated with a high barrier to resistance.
• Always test for Hepatitis B virus (HBV) co-infection before starting Biktarvy due to the risk of severe HBV exacerbation upon discontinuation.
• Counsel patients on the importance of strict adherence to once-daily dosing to maintain viral suppression and prevent resistance.
• Advise patients to separate Biktarvy from polyvalent cation-containing antacids, iron, or calcium supplements by at least 2 hours before or 6 hours after, unless taken with food, in which case they can be taken together.
• Monitor renal function periodically, especially in patients with pre-existing renal impairment or those on concomitant nephrotoxic agents.

• Other INSTI-based regimens (e.g., dolutegravir-based, raltegravir-based)
• NNRTI-based regimens (e.g., doravirine-based, rilpivirine-based)
• Protease Inhibitor (PI)-based regimens (e.g., darunavir-based, atazanavir-based)
• Long-acting injectable regimens (e.g., cabotegravir/rilpivirine)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.