WARNING

The risks associated with taking Bictegravir, Emtricitabine, and Tenofovir Alafenamide include:

• Kidney Issues: Tenofovir Alafenamide, one of the components, can cause kidney problems, including decreased kidney function and kidney failure. Regular monitoring of kidney function is necessary during treatment.
• Bone Density Loss: Tenofovir Alafenamide may lead to bone density loss, increasing the risk of fractures or osteoporosis. Monitoring bone health and considering supplements or lifestyle modifications may be necessary.
• Liver Problems: Emtricitabine and Tenofovir Alafenamide can affect liver function, potentially leading to liver damage or liver failure. Liver function tests may be required before and during treatment.
• Immune Reconstitution Syndrome: Starting antiretroviral therapy, including this medication, may trigger immune reconstitution syndrome, where the recovering immune system causes inflammation or exacerbation of pre-existing conditions.
• Lactic Acidosis: Rarely, Tenofovir Alafenamide can cause a buildup of lactic acid in the blood, leading to lactic acidosis, which can be life-threatening. Symptoms include weakness, muscle pain, difficulty breathing, and abdominal discomfort.
• Drug Interactions: This medication can interact with other medications, potentially affecting their efficacy or increasing the risk of side effects. It’s crucial to inform healthcare providers about all medications and supplements being taken.
• Allergic Reactions: Some individuals may experience allergic reactions to components of the medication, leading to symptoms such as rash, itching, swelling, or difficulty breathing.
• Resistance: Inadequate adherence to the medication can lead to the development of drug-resistant strains of HIV, reducing the effectiveness of future treatment options.

It’s essential for individuals considering or using this medication to discuss these risks with their healthcare provider and to adhere closely to their treatment plan to minimize potential complications.

Why is this medication prescribed?

Bictegravir, emtricitabine, and tenofovir alafenamide are prescribed for the treatment of HIV-1 infection in adults. This medication is a combination of three different drugs that work together to inhibit the replication of the HIV virus in the body. Bictegravir is an integrase strand transfer inhibitor (INSTI), while emtricitabine and tenofovir alafenamide are both nucleoside reverse transcriptase inhibitors (NRTIs).

The combination of these drugs provides a convenient once-daily dosing regimen, simplifying the treatment for HIV-infected individuals and improving adherence to the medication.

How should this medicine be used?

Bictegravir, emtricitabine, and tenofovir alafenamide are typically used for the treatment of HIV-1 infection in adults. The usual dosage and administration instructions are as follows:

• Dosage: The recommended dosage for this combination medication is one tablet taken orally once daily.
• Administration: It can be taken with or without food. It’s essential to take the medication consistently at the same time each day to maintain therapeutic levels in the body.
• Swallowing: The tablets should be swallowed whole and not crushed, chewed, or broken.
• Adherence: It’s crucial to adhere to the prescribed dosing regimen to ensure the effectiveness of the medication in suppressing the HIV virus and preventing the development of drug resistance.
• Consultation with Healthcare Provider: Patients should consult their healthcare provider regarding any questions or concerns about the medication, including its potential side effects, drug interactions, and overall management of their HIV treatment.
• Regular Monitoring: Patients taking this combination medication should undergo regular monitoring, including laboratory tests to assess their HIV viral load, CD4 cell count, and any potential adverse effects of the medication.

It’s important to note that Bictegravir, Emtricitabine, and Tenofovir Alafenamide are prescription medications, so they should only be used under the supervision of a healthcare professional who can monitor their effects and ensure their appropriate use. Additionally, patients should consult their healthcare provider regarding any questions or concerns about the medication.

Other uses for this medicine

Bictegravir, emtricitabine, and tenofovir alafenamide are primarily indicated for the treatment of HIV-1 infection in adults. However, there are no significant alternative therapeutic uses approved for this combination medication beyond HIV treatment.

What special precautions should I follow?

Special precautions to follow when taking Bictegravir, Emtricitabine, and Tenofovir Alafenamide include:

• Consultation with Healthcare Provider: Before starting it or any other HIV medication, it’s crucial to consult with a healthcare provider who can evaluate your medical history, current medications, and overall health status to determine if this medication is suitable for you.
• Drug Interactions: Inform your healthcare provider about all the medications, supplements, and herbal products you are currently taking, as certain medications may interact with Bictegravir, Emtricitabine, and Tenofovir Alafenamide, potentially affecting their effectiveness or increasing the risk of side effects.
• Renal Function Monitoring: Tenofovir alafenamide, one of the components of this combination medication, can affect kidney function. Regular monitoring of kidney function, including serum creatinine and estimated glomerular filtration rate (eGFR), is recommended before starting treatment and periodically thereafter, especially in patients with pre-existing kidney disease or risk factors for kidney dysfunction.
• Bone Density: Tenofovir alafenamide may also affect bone mineral density. Healthcare providers may consider monitoring bone mineral density in patients at risk of osteoporosis or bone fractures.
• Hepatitis B Coinfection: If you have hepatitis B virus (HBV) infection along with HIV-1, discontinuing this combination medication suddenly can worsen your hepatitis B infection. Your healthcare provider may advise you to continue taking medications to treat your HBV infection while also taking this medication.
• Pregnancy and Breastfeeding: It’s essential to discuss the risks and benefits of this combination medication if you are pregnant or planning to become pregnant. Pregnant individuals with HIV should receive appropriate HIV treatment to prevent transmission to the fetus. Additionally, it’s recommended to avoid breastfeeding while taking this combination medication, as the medication may pass into breast milk.
• Adherence to Treatment: It’s important to adhere to the prescribed dosing regimen and follow-up appointments with your healthcare provider to monitor your response to treatment, viral load, and overall health status.

What special dietary instructions should I follow?

Bictegravir, Emtricitabine, and Tenofovir Alafenamide can be taken with or without food. There are no specific dietary restrictions associated with this medication.

What should I do if I forget a dose?

• Take It as Soon as You Remember: If you miss a dose, take it as soon as you remember. However, if it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Do Not Double Dose: Do not take a double dose to make up for a missed one. Taking more than the prescribed amount can increase the risk of side effects without providing additional benefits.
• Notify Your Healthcare Provider: If you frequently forget doses or have difficulty adhering to the prescribed dosing schedule, inform your healthcare provider. They may offer strategies to help you remember or adjust your treatment plan if necessary.

What side effects can this medication cause?

Bictegravir, emtricitabine, and tenofovir alafenamide are generally well-tolerated medications for the treatment of HIV-1 infection, but like all medications, they can cause side effects in some individuals. Common side effects may include:

• Nausea: Feeling of discomfort or queasiness in the stomach.
• Diarrhea: Frequent bowel movements with loose or watery stools.
• Headache: Pain or discomfort in the head, often described as aching or throbbing.
• Fatigue: Feeling of tiredness or lack of energy.
• Dizziness: Sensation of lightheadedness or unsteadiness.
• Insomnia: Difficulty falling asleep or staying asleep.
• Rash: Skin irritation or redness, which may be accompanied by itching.
• Abnormal Liver Function Tests: Changes in liver function tests may occur, but serious liver problems are rare.
• Renal Effects: Tenofovir alafenamide, one of the components of the medications, may cause changes in kidney function, although this is less common compared to its predecessor, tenofovir disoproxil fumarate.
• Bone Density Reduction: Tenofovir alafenamide may also lead to decreased bone mineral density over time, increasing the risk of fractures or osteoporosis, although the clinical significance of this effect is still under investigation.

It’s important to note that not everyone will experience these side effects, and some individuals may experience side effects not listed here. Additionally, serious side effects are rare but can occur. These may include severe allergic reactions, lactic acidosis (a buildup of lactic acid in the bloodstream), liver problems, and exacerbation of hepatitis B virus infection in individuals co-infected with HIV and HBV.

If you experience any persistent or severe side effects while taking Bictegravir, Emtricitabine, and Tenofovir Alafenamide, it’s crucial to notify your healthcare provider promptly. They can evaluate your symptoms and determine whether any adjustments to your treatment plan are necessary.

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

Storage and disposal:

• Storage: Store tablets at room temperature between 20°C to 25°C (68°F to 77°F). Keep the medication in its original container, tightly closed, and away from moisture and heat. Avoid storing it in the bathroom or kitchen where it may be exposed to moisture.
• Disposal: Dispose of unused or expired tablets properly according to local regulations or guidelines. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Contact your healthcare provider or pharmacist for advice on how to dispose of medication safely.

In case of emergency/overdose

In case of an emergency or suspected overdose of Bictegravir, Emtricitabine, and Tenofovir Alafenamide, seek medical assistance immediately by calling emergency services or visiting the nearest emergency room. Symptoms of overdose may include severe nausea, vomiting, dizziness, or loss of consciousness.

What other information should I know?

• Always take this medication exactly as prescribed by your healthcare provider. Do not change the dose or stop taking it without consulting your doctor.
• Inform your healthcare provider about all other medications, vitamins, or supplements you are taking, as they may interact with bictegravir, emtricitabine, and tenofovir alafenamide.
• It’s important to take this medication regularly to maintain the effectiveness of HIV treatment and to prevent the development of drug-resistant strains of HIV.
• This medication does not cure HIV infection but helps to control it. Therefore, it’s important to continue taking it even if you feel well.
• Monitor for any signs of side effects or adverse reactions and report them to your healthcare provider promptly.

Always consult your healthcare provider or pharmacist if you have any specific questions or concerns about the storage, disposal, or usage of bictegravir, emtricitabine, and tenofovir alafenamide.