Important Safety Information

Before prescribing TRUVADA for a PrEP indication, please review the complete Important Safety Information. To access a specific section of the Important Safety Information, use the links below:

Important Safety Information About TRUVADA for a PrEP Indication

BOXED WARNING:

  • TRUVADA for a PrEP indication must only be prescribed to individuals confirmed to be HIV-1 negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with the 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 infection are present unless negative infection status is confirmed
  • TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients infected with HBV who have discontinued TRUVADA. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in HBV-infected patients who discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted

Contraindications: DO NOT PRESCRIBE TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-1 infected patients only in combination with other antiretroviral agents.

Warnings and Precautions Relating to the Use of TRUVADA for a PrEP Indication

  • Comprehensive management strategies to reduce potential risks associated with use of TRUVADA for a PrEP indication:
    • Strategy to reduce uninfected individual's exposure to HIV-1 infection includes safer sex practices such as consistent and correct use of condoms, an individual knowing their HIV-1 status and that of their partner(s), regular testing for HIV-1 and other sexually transmitted infections, and counseling regarding reducing sexual risk behavior
    • Strategies to reduce potential for drug resistance: TRUVADA must only be used for PrEP in individuals confirmed to be HIV-1 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 regimen for HIV-1 treatment
      • Confirm negative HIV-1 status immediately prior to initiating TRUVADA for PrEP. Do not initiate TRUVADA for PrEP if signs or symptoms of HIV-1 infection are present (e.g., fever, fatigue, myalgia, skin rash, etc.) or if recent exposure (<1 month) is suspected. Alternatively, delay initiating PrEP for at least one month or confirm negative HIV-1 status using a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
      • Screen for HIV-1 infection at least every three (3) months. Discontinue TRUVADA for PrEP if signs or symptoms of acute infection develop after potential exposure event until negative HIV-1 status is confirmed using a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
    • Counsel all uninfected individuals to strictly adhere to their TRUVADA daily dosing schedule because the effectiveness of TRUVADA for PrEP is correlated with adherence and measurable drug levels
  • New or worsening renal impairment: ¬†¬†Acute renal impairment including Fanconi syndrome may occur. Assess estimated creatinine clearance (CrCl) before prescribing and periodically during therapy with TRUVADA. In patients at risk of renal dysfunction, monitor estimated CrCl, serum phosphorus, urine glucose and urine protein before prescribing TRUVADA. Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs. Cases of acute renal failure, some requiring hospitalization and renal replacement therapy, have been reported after initiation of high dose or multiple NSAIDs in patients with risk factors for renal dysfunction; consider alternatives to NSAIDs in these patients
    • Do not prescribe TRUVADA for uninfected individuals with an estimated CrCl below 60 mL/min. If a decrease in estimated CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use
  • HBV Infection: It is recommended that all individuals be tested for the presence of chronic hepatitis B virus (HBV) before initiating TRUVADA. HBV-uninfected individuals should be offered vaccination
  • Lactic acidosis/severe hepatomegaly with steatosis: Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
  • Bone effects: Consider assessment of bone mineral density (BMD) in individuals with history of bone fractures, osteoporosis, or bone loss. Persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness may be manifestations of proximal renal tubulopathy and should prompt an evaluation of renal function in at-risk patients
  • Coadministration with other products: Do not co-administer with other drugs containing emtricitabine, tenofovir disoproxil fumarate, or tenofovir alafenamide, with drugs containing lamivudine, or with adefovir dipivoxil

Common Adverse Reactions

In HIV-1 uninfected individuals in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA subjects and more frequently than by placebo subjects were headache, abdominal pain and decreased weight.

Potential Drug Interactions

Coadministration of TRUVADA with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir

Please see Prescribing Information for more information about potential drug interactions.

Use of TRUVADA for PrEP in Specific Populations

  • Pregnancy: There are no adequate and well-controlled trials in pregnant women. TRUVADA should be used during pregnancy only if clearly needed. If an uninfected individual becomes pregnant while taking TRUVADA for a PrEP indication, careful consideration should be given to whether use of TRUVADA should be continued, taking into account the potential increased risk of HIV-1 infection during pregnancy
    • A pregnancy registry is available. Enroll women taking TRUVADA for a PrEP indication by calling 1-800-258-4263
  • Nursing mothers: The components of TRUVADA (emtricitabine and tenofovir disoproxil fumarate) are excreted in breast milk. Because the risks to the infant are not known, mothers taking TRUVADA for a PrEP indication should be instructed not to breastfeed. If an uninfected individual acquires HIV-1 infection, it is recommended that she not breastfeed to avoid risking postnatal transmission of HIV-1
  • Pediatrics: The TRUVADA for a PrEP indication is based on studies in adults

Dosage and Administration

  • Adults: Dosage of TRUVADA for PrEP for adults is one tablet once per day orally with or without food
  • Dose Adjustment for Renal Impairment: Do not prescribe TRUVADA for uninfected individuals with an estimated CrCL below 60 mL/min. If a decrease in estimated CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use

Indication and Usage for Pre-exposure Prophylaxis

TRUVADA® (emtricitabine/tenofovir disoproxil fumarate), a combination of EMTRIVA® (emtricitabine) and VIREAD® (tenofovir disoproxil fumarate), 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. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.

Factors that may help identify individuals at high risk include: has partner(s)
known to be HIV-1 infected or engages in sexual activity within a high prevalence area or social network and one or more of the following: inconsistent or no condom use, diagnosis of sexually transmitted infections, exchange of sex for commodities (such as money, food, shelter, or drugs), use of illicit drugs or alcohol dependence, incarceration, or partner(s) of unknown HIV-1 status with any of the factors listed above.

The following points must be considered when prescribing TRUVADA for pre-exposure prophylaxis:

  • Prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection
  • Counsel all uninfected individuals to strictly adhere to their TRUVADA daily dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 infection is strongly correlated with adherence and measurable drug levels
  • Confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least 1 month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
  • Screen uninfected individuals for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP

Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present

Please report adverse events to Gilead by calling 1-800-445-3235. Adverse events can also be reported to the FDA through www.fda.gov/medwatch or by calling 1-800-FDA-1088.

The information on this site is intended for adult residents
of the United States.

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