INDICATIONS AND USAGE

Treatment of HIV-1 Infection

Emtricitabine and tenofovir disoproxil fumarate 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 Pre-Exposure Prophylaxis (PrEP)

Emtricitabine and tenofovir disoproxil fumarate is 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 for HIV-1 PrEP.

DOSAGE

Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg

Emtricitabine and tenofovir disoproxil fumarate is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The recommended dosage of emtricitabine and tenofovir disoproxil fumarate in adults and in pediatric patients weighing at least 35 kg is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.

Recommended Dosage for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Tablet

Tablets should be taken once daily with or without food. Weight should be monitored periodically and the emtricitabine and tenofovir disoproxil fumarate dose adjusted accordingly.

17 to less than 22 kg: one 100 mg /150 mg tablet once daily

22 to less than 28 kg: one 133 mg /200 mg tablet once daily

28 to less than 35 kg: one 167 mg /250 mg tablet once daily

Recommended Dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg

The dosage of emtricitabine and tenofovir disoproxil fumarate for HIV-1 PrEP is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food in HIV-1 uninfected adults and adolescents weighing at least 35 kg.

ADVERSE REACTIONS

Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection

New Onset or Worsening Renal Impairment

Immune Reconstitution Syndrome

Bone Loss and Mineralization Defects

Lactic Acidosis/Severe Hepatomegaly with Steatosis

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/54e82b13-a037-49ed-b4b3-030b37c0ecdd/spl-doc?hl=Truvada

Ricovir EMinformation