Emtricitabine (23 brand names, 3 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, SOLUTION.
Routes of administration: ORAL.
Brand Names
- ATRIPLA
- BIKTARVY
- COMPLERA
- DESCOVY
- DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE
- EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE
- EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- EMTRICITABINE
- EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE
- EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
- EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
- EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDE
- EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE
- EMTRICITABINE; TENOFOVIR ALAFENAMIDE
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- EMTRIVA
- GENVOYA
- ODEFSEY …and 3 more
Boxed Warning
Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine and tenofovir disoproxil fumarate. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)]. Emtricitabine and tenofovir disoproxil fumarate used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.2)].
Contraindications
Emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)].
Adverse Reactions
The following adverse reactions are discussed in other sections of the labeling: •Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions (5.1)]. •New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3)]. •Immune Reconstitution Syndrome [see Warnings and Precautions (5.4)]. •Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5)]. • Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.6)].
Mechanism of Action
Emtricitabine and tenofovir disoproxil fumarate tablets are a fixed-dose combination of antiviral drugs FTC and TDF [see Microbiology (12.4)].
Overdosage
If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Emtricitabine: 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 Disoproxil Fumarate: Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of TDF, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.