INDICATION
BIXLENVO is indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected resistance to the individual components of BIXLENVO.
IMPORTANT SAFETY INFORMATION
Contraindications
- Coadministration: Concomitant administration of BIXLENVO is contraindicated with dofetilide and strong CYP3A inducers.
Warnings and precautions
- See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIXLENVO therapy and monitor for adverse reactions.
Adverse reactions
- Most common adverse reactions (incidence ≥ 2%; all grades) reported in clinical trials were headache (4%), nausea (3%), and diarrhea (2%).
Drug interactions
- Prescribing Information: Consult the full Prescribing Information for BIXLENVO for more information on contraindications, warnings, and potentially significant drug interactions, including clinical comments.
- Enzymes/transporters: Drugs that are both a strong inducer of CYP3A and induce UGT1A1 can substantially decrease the concentration of components of BIXLENVO. Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentrations of components of BIXLENVO. Drugs that are both a strong CYP3A inhibitor and a UGT1A1 inhibitor, or combined P-gp, UGT1A1, and strong CYP3A inhibitors can significantly increase concentrations of components of BIXLENVO.
Dosage and administration
- Dosage: Two-day initiation regimen of BIXLENVO 1 tablet plus SUNLENCA 2 tablets taken orally daily, followed by
a maintenance regimen of BIXLENVO 1 tablet orally once daily. Tablets may be
taken with or without food.
- Day 1: BIXLENVO 1 tablet of 75 mg/50 mg orally AND SUNLENCA 2 tablets of 300 mg orally (600 mg dose)
- Day 2: BIXLENVO 1 tablet of 75 mg/50 mg orally AND SUNLENCA 2 tablets of 300 mg orally (600 mg dose)
- Day 3 and once daily thereafter: BIXLENVO 1 tablet of 75 mg/50 mg orally once daily
- Missed dose: If the initiation doses of BIXLENVO or SUNLENCA are missed, patients should take them as soon as possible. Patients should not take both Day 1 and Day 2 doses of SUNLENCA on the same day. Patients should take missed maintenance doses as soon as possible. If more than 7 days have elapsed since the last maintenance dose, restart initiation dosage regimen from Day 1, if clinically appropriate to continue treatment.
Pregnancy and lactation
- Pregnancy: Lower exposures of bictegravir were observed in clinical studies with a bictegravir-containing regimen, therefore, viral load should be monitored closely in pregnant individuals. An Antiretroviral Pregnancy Registry (APR) has been established.
- Lactation: Individuals with HIV-1 should be informed of the potential risks of breastfeeding.
Please see full Prescribing Information for BIXLENVO.