Skip to Content

Label Changes for:

Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) Tablets

July 2012

Changes have been made to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 


July 2012 


  • 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


  • Do not use TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-infected patients only in combination with other antiretroviral agents


New Onset or Worsening Renal Impairment

Pre-exposure Prophylaxis

  • TRUVADA for a PrEP indication should not be used if creatinine clearance is less than 60 mL/min. If a decrease in creatinine clearance is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use

Decreases in Bone Mineral Density

  • Assessment of bone mineral density (BMD) should be considered for adults and in pediatric patients 12 years of age and older who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Although the effect of supplementation with calcium and vitamin D was not studied, such supplementation may be beneficial. If bone abnormalities are suspected then appropriate consultation should be obtained. In a clinical trial of HIV-1 infected pediatric subjects 12 years of age and older (Study 321), bone effects were similar to adult subjects….

Immune Reconstitution Syndrome

  • Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution, however, the time to onset is more variable, and can occur many months after initiation of treatment.

Comprehensive Management to Reduce the Risk of Acquiring HIV-1

  • Use TRUVADA for pre-exposure prophylaxis only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because TRUVADA is not always effective in preventing the acquisition of HIV-1 [See Clinical Studies (14.2 and 14.3)]. Counsel uninfected individuals about safer sex practices that include consistent and correct use of condoms, knowledge of their HIV-1 status and that of their partner(s), and regular testing for other sexually transmitted infections that can facilitate HIV-1 transmission (such as syphilis and gonorrhea).
  • Inform uninfected individuals about and support their efforts in reducing sexual risk behavior.
  • Use TRUVADA to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only TRUVADA, because TRUVADA alone does not constitute a complete treatment regimen for HIV-1 treatment [See Microbiology: Resistance (12.4)]; therefore, care should be taken to minimize drug exposure in HIV-infected individuals.
  • Many HIV-1 tests, such as rapid tests, detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating TRUVADA for a PrEP indication, evaluate seronegative individuals for current or recent signs or symptoms consistent with acute viral infections (e.g., fever, fatigue, myalgia, skin rash, etc.) and ask about potential exposure events (e.g., unprotected, or condom broke during sex with an HIV-1 infected partner) that may have occurred within the last month…. 



July 2011


5.5 Decreases in Bone Mineral Density
  • Assessment of bone mineral density (BMD) should be considered for HIV-1 infected adults and pediatric patients 12 years of age and older...
  • In a clinical trial of HIV-1 infected pediatric subjects 12 years...


November 2009 


New Onset or Worsening Renal Impairment
  • Routine monitoring of calculated creatinine clearance and serum phosphorus should be performed.. including patients who have previously experienced renal events while receiving Hepsera.


Postmarketing Experience
  • Immune System Disorders: including angioedema


Information for Patients
  • Patients should be advised to continue to practice safer sex and to use latex or polyurethane condoms to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions or blood. Patients should be advised never to re-use or share needles.
What are the possible side effects of TRUVADA?
  • Changes in bone mineral density (thinning bones). Some HIV patients treated with tenofovir developed thinning of the bones (osteopenia) which could lead to fractures.