TRUVADA
Details
- Status
- Prescription
- First Approved
- 2004-08-02
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
TRUVADA Approval History
What TRUVADA Treats
1 indicationsTRUVADA is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
TRUVADA Boxed Warning
LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals [see Warnings and Precautions (5.1) ] . TRUVADA is not appr...
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals [see Warnings and Precautions (5.1) ] . TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued TRUVADA. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.2) ] . TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.9) ] . WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning. Lactic acidosis and severe hepatomegaly with steatosis, incl
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRUVADA FDA Label Details
ProIndications & Usage
FDA Label (PDF)TRUVADA is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors. TRUVADA 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. TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. 1.1 Treatment of HIV-1 Infection TRUVADA ® , a combination of EMTRIVA ® and VIREAD ® , is indicated in combination with other antiretroviral agents for the tr...
WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fa...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.