Bictegravir

What it is used for

BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg:

• with no antiretroviral treatment history, or
• with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir, or
• 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 substitutions associated with resistance to bictegravir or tenofovir.

Side effects, and when to stop

The following adverse reactions are discussed in other sections of the labeling:

• Severe Acute Exacerbations of Hepatitis B.
• Immune Reconstitution Syndrome.
• New Onset or Worsening Renal Impairment.
• Lactic Acidosis/Severe Hepatomegaly with Steatosis.

Who should not take it

BIKTARVY is contraindicated to be co-administered with:

• dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events.
• rifampin due to decreased BIC plasma concentrations, which may result in the loss of therapeutic effect and development of resistance to BIKTARVY.

Storing it

Store bottle below 30 °C (86 °F).

Keep bottle tightly closed.

The bottle containing 50 mg/200 mg/25 mg tablets (NDC 61958-2501-1) may have a tamper-evident seal over the cap. If a tamper-evident seal is present, do not use if the seal is opened or damaged.

Store blister pack at 25 °C (77 °F), excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature).

Dispense only in original containers.