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Generic Name
Emtricitabine
Brand Names
Biktarvy, Genvoya, Efavirenz, Stribild, Complera, Truvada, Odefsey, Emtriva, Descovy
FDA approval date: July 02, 2003
Classification: Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Form: Tablet, Capsule, Solution
What is Biktarvy (Emtricitabine)?
Emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets are indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or, to replace a stable antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen for at least 6 months with no treatment failure and no known substitutions associated with resistance to the individual components of emtricitabine, rilpivirine and tenofovir disoproxil fumarate tablets [see Microbiology (1.
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Brand Information
Biktarvy (bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate)
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
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 with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue BIKTARVY. If appropriate, anti-hepatitis B therapy may be warranted
1INDICATIONS AND USAGE
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:
- 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 known or suspected substitutions associated with resistance to bictegravir or tenofovir.
2DOSAGE FORMS AND STRENGTHS
BIKTARVY tablets are available in two dose strengths:
- 50 mg/200 mg/25 mg tablets: 50 mg of bictegravir (BIC) (equivalent to 52.5 mg of bictegravir sodium), 200 mg of emtricitabine (FTC), and 25 mg of tenofovir alafenamide (TAF) (equivalent to 28 mg of tenofovir alafenamide fumarate). These tablets are purplish brown, capsule-shaped, film-coated, and debossed with "GSI" on one side and "9883" on the other side.
- 30 mg/120 mg/15 mg tablets: 30 mg of BIC (equivalent to 31.5 mg of bictegravir sodium), 120 mg of FTC, and 15 mg of TAF (equivalent to 16.8 mg of tenofovir alafenamide fumarate). These tablets are pink, capsule-shaped, film-coated, and debossed with "GSI" on one side and "B" on the other side.
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
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
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
4.2Postmarketing Experience
The following events have been identified during post approval use of BIKTARVY or products containing TAF. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5OVERDOSAGE
No data are available on overdose of BIKTARVY in patients. If overdose occurs, monitor the patient for evidence of toxicity. Treatment of overdose with BIKTARVY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether FTC can be removed by peritoneal dialysis.
Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
6DESCRIPTION
BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) is a fixed dose combination tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration.
- BIC is an integrase strand transfer inhibitor (INSTI).
- FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI).
- TAF, an HIV NRTI, is converted
BIKTARVY tablets are available in two dose strengths:
- 50 mg/200 mg/25 mg tablet containing 50 mg of BIC (equivalent to 52.5 mg of bictegravir sodium),
- 30 mg/120 mg/15 mg tablet containing 30 mg of BIC (equivalent to 31.5 mg of bictegravir sodium), 120 mg of FTC, and 15 mg of TAF (equivalent to 16.8 mg of tenofovir alafenamide fumarate).
Both dose strengths of BIKTARVY tablets include the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets for both dose strengths are film-coated with a coating material containing iron oxide black, iron oxide red, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
7HOW SUPPLIED/STORAGE AND HANDLING
Product: 50090-6247
NDC: 50090-6247-0 30 TABLET in a BOTTLE, PLASTIC
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9BIKTARVY
