emtricitabine and tenofovir disoproxil fumarate
emtricitabine and tenofovir disoproxil fumarate is listed in the FDA National Drug Code directory with 15 NDC codes, marketed under brand name including Truvada. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- emtricitabine and tenofovir disoproxil fumarate
- Brand Names
- Truvada
- Application Number
- NDA021752
- Sponsor
- Gilead Sciences, Inc
- NDC Codes
- 15
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ) Emtricitabine and tenofovir disoproxil fumarate tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. HIV-1 PrEP ( 1.2 ): Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP. 1.1 Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies ( 14 )] . 1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP) Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 )].