WARNINGS
BIKTARVY may cause serious side effects, including: • Worsening of hepatitis B (HBV). Your healthcare provider will test you for HBV. If you have both HIV-1 and HBV, your HBV may suddenly get worse if you stop taking BIKTARVY. Do not stop taking BIKTARVY without first talking to your healthcare provider, as they will need to check your health regularly for several months, and may give you HBV medicine.
BIKTARVY does not cure HIV-1 or AIDS. HIV-1 is the virus that causes AIDS. Do NOT take BIKTARVY if you also take a medicine that contains: • dofetilide • rifampin • any other medicines to treat HIV-1
USES
BIKTARVY is a complete, 1-pill, once-a-day prescription medicine used to treat HIV-1 in adults and children who weigh at least 31 pounds. It can either be used in people who have never taken HIV-1 medicines before, or people who have received HIV-1 medicines in the past, or to replace their current HIV-1 medicines, and whose healthcare provider determines they meet certain requirements.
HOW TO USE
Take BIKTARVY 1 time each day with or without food.
BIKTARVY can cause serious side effects, including:
• See the sections WARNINGS and PRECAUTIONS above.
• Changes in your immune system.
• New or worse kidney problems, including kidney failure.
• Too much lactic acid in your blood (lactic acidosis), which is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
• Severe liver problems, which in rare cases can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark “tea-colored” urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.
• The most common side effects of BIKTARVY in clinical studies were diarrhea (6%), nausea (6%), and headache (5%). These are not all the possible side effects of BIKTARVY. Tell your healthcare provider right away if you have any new symptoms while taking BIKTARVY. Your healthcare provider will need to do tests to monitor your health before and during treatment with BIKTARVY.
How should I store BIKTARVY?
Store BIKTARVY bottle below 86-degrees F (30-degrees C).
Keep the bottle tightly closed.
BIKTARVY contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not eat the desiccant packet.
Store BIKTARVY blister pack at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
Keep BIKTARVY in its original bottle or blister pack.
BIKTARVY comes in a child-resistant package.
Keep BIKTARVY and all medicines out of reach of children.
What are the ingredients in BIKTARVY?
Active ingredients: bictegravir, emtricitabine, and tenofovir alafenamide.
Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.
The tablets are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
How should I store BIKTARVY?
• Store BIKTARVY bottle below 86-degrees F (30-degrees C).
• Keep the bottle tightly closed.
• BIKTARVY contains a desiccant packet to help keep your medicine dry (protect it from moisture). Keep the desiccant packet in the bottle. Do not eat the desiccant packet.
• Store BIKTARVY blister pack at room temperature between 68-degrees F to 77-degrees F (20-degrees C to 25-degrees C).
• Keep BIKTARVY in its original bottle or blister pack.
• BIKTARVY comes in a child-resistant package.
Keep BIKTARVY and all medicines out of reach of children.
NOTES
Medication Guide: revision date 07/2025
Prescribing Information: revision date 07/2025
1.) Other Antiretroviral Medications
Because BIKTARVY is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended [see the section USE above]. Comprehensive information regarding potential drug-drug interactions with other antiretroviral medications is not provided because the safety and efficacy of concomitant HIV-1 antiretroviral therapy is unknown.
2.) Potential for BIKTARVY to Affect Other Drugs
BIC inhibits organic cation transporter 2 (OCT2) and multidrug and toxin extrusion transporter 1 (MATE1) in vitro. Coadministration of BIKTARVY with drugs that are substrates of OCT2 and MATE1 (e.g., dofetilide) may increase their plasma concentrations.
3.) Potential Effect of Other Drugs on One or More Components of BIKTARVY
BIC is a substrate of CYP3A and UGT1A1. A drug that is a strong inducer of CYP3A and also an inducer of UGT1A1 can substantially decrease the plasma concentrations of BIC which may lead to loss of therapeutic effect of BIKTARVY and development of resistance.
The use of BIKTARVY with a drug that is a strong inhibitor of CYP3A and also an inhibitor of UGT1A1 may significantly increase the plasma concentrations of BIC.
TAF is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Co-administration of drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentrations of TAF. Co-administration of drugs that induce P-gp activity are expected to decrease the absorption of TAF, resulting in decreased plasma concentration of TAF, which may lead to loss of therapeutic effect of BIKTARVY and development of resistance.
4.) Drugs Affecting Renal Function
Because FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion, coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC, tenofovir, and other renally eliminated drugs and this may increase the risk of adverse reactions. Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see the sections WARNINGS and PRECAUTIONS above].
5.) Established and Potentially Significant Drug Interactions
Table 3 provides a listing of established or potentially clinically significant drug interactions with recommended prevention or management strategies. The drug interactions described are based on studies conducted with either BIKTARVY, the components of BIKTARVY (BIC, FTC, and TAF) as individual agents, or are drug interactions that may occur with BIKTARVY [see the sections WARNINGS and PRECAUTIONS above].
Tell your healthcare provider all your medical conditions, including if you:
• Have or have had any kidney or liver problems, including hepatitis.
• Are pregnant or plan to become pregnant.
• Are breastfeeding (nursing) or plan to breastfeed. Talk to your healthcare provider about the risks of breastfeeding during treatment with BIKTARVY. Tell your healthcare provider about all the medicines you take:
• Keep a list that includes all prescription and over-thecounter medicines, antacids, laxatives, vitamins, and herbal supplements, and show it to your healthcare provider and pharmacist.
• Ask your healthcare provider or pharmacist about medicines that interact with BIKTARVY.
