Clinical Information
Gen. Code and Des.
78146 bictegrav/emtricit/tenofov ala ORAL TABLET 50-200-25
GCN and Des.
44426 bictegrav/emtricit/tenofov ala ORAL TABLET 50-200-25
Strength
50/225MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
8180820 HIV NUCLEOSIDE, NUCLEOTIDE RT INHIBITORS
8180812 HIV INTEGRASE INHIBITOR ANTIRETROVIRALS
Active Ingredients
1321 emtricitabine 143491570
16564 tenofovir alafenamide fumarate
17461 bictegravir sodium
For: HIV Infection
Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide) is an integrase strand transfer inhibitor and emtricitabine/tenofovir alafenamide (Descovy) combination for the treatment of HIV-1 infection in adults. BIKTARVY tablets are purplish brown, capsule-shaped, and film-coated with "GSI" debossed on one side and "9883" on the other side. Each bottle contains 30 tablets (NDC 61958-2501-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure. Each BIKTARVY tablet contains 50 mg of bictegravir (BIC), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF).
Store below 30 �C (86 �F).
Keep container tightly closed.
Dispense only in original container. These highlights do not include all the information needed to use BIKTARVY safely and effectively. See full prescribing information for BIKTARVY.
BIKTARVY � (bictegravir, emtricitabine, and tenofovir alafenamide) tablets, for oral use
Initial U.S. Approval: 2018
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
See full prescribing information for complete boxed warning.
Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function in these patients. If appropriate, anti-hepatitis B therapy may be warranted. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1) 06/2019
Dosage and Administration, Recommended Dosage (2.2) 06/2019
Warnings and Precautions, Immune Reconstitution Syndrome (5.3) 06/2019
INDICATIONS AND USAGE
BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history 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 history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY. (1)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating BIKTARVY test for hepatitis B virus infection. Prior to or when initiating BIKTARVY, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus. (2.1)
Recommended dosage: One tablet taken once daily with or without food in patients weighing at least 25 kg. (2.2)
Renal impairment: BIKTARVY is not recommended in patients with estimated creatinine clearance below 30 mL per minute. (2.3)
Hepatic impairment: BIKTARVY is not recommended in patients with severe hepatic impairment. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg of bictegravir (equivalent to 52.5 mg of bictegravir sodium), 200 mg of emtricitabine, and 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate). (3)
CONTRAINDICATIONS
BIKTARVY is contraindicated to be co-administered with:
dofetilide. (4)
rifampin. (4)
WARNINGS AND PRECAUTIONS
Immune reconstitution syndrome: May necessitate further evaluation and treatment. (5.3)
New onset or worsening renal impairment: Assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein when initiating BIKTARVY and during therapy as clinically appropriate in all patients. Also assess serum phosphorus in patients with chronic kidney disease. (5.4)
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.5)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or equal to 5%, all grades) are diarrhea, nausea, and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Because BIKTARVY is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. (7.1)
Consult the Full Prescribing Information prior to and during treatment for important drug interactions. (4, 5.2, 7, 12.3)
USE IN SPECIFIC POPULATIONS
Lactation: Women infected with HIV should be instructed not to breastfeed due to the potential for HIV transmission. (8.2)
Pediatrics: Not recommended for patients weighing less than 25 kg. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2019
