Truvada

TRUVADA- emtricitabine and tenofovir disoproxil fumarate tablet, film coated
NuCare Pharmaceuticals,Inc.

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)] .

1 INDICATIONS AND USAGE

1.1 Treatment of HIV-1 Infection

TRUVADA ® , a combination of EMTRIVA ® and VIREAD ® , 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 [see Dosage and Administration (2) and Clinical Studies (14)] .

The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:

  • It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen.
  • TRUVADA should not be coadministered with ATRIPLA ® , COMPLERA ® , EMTRIVA, GENVOYA ® , ODEFSEY ® , STRIBILD ® , VIREAD or lamivudine-containing products [see Warnings and Precautions (5.4)] .
  • In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history [see Microbiology (12.4)] .

1.2 Pre-Exposure Prophylaxis

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. 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 [see Clinical Studies (14.2, 14.3)] .

When considering TRUVADA for pre-exposure prophylaxis the following factors may help to identify individuals at high risk:

  • 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
    • partner(s) of unknown HIV-1 status with any of the factors listed above

When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must:

  • prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [see Warnings and Precautions (5.9)] ;
  • counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [see Warnings and Precautions (5.9)] ;
  • 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 one 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 [see Warnings and Precautions (5.9)] ; and
  • screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More

The recommended dose of TRUVADA in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

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

The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet, is one TRUVADA low strength tablet (emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) (167 mg/250 mg, 133 mg/200 mg, or 100 mg/150 mg based on body weight) taken orally once daily with or without food.

The recommended oral dosage of TRUVADA low strength tablets is presented in Table 1. Weight should be monitored periodically and the TRUVADA dose adjusted accordingly.

Table 1 Dosing for Pediatric Patients Weighing 17 kg to less than 35 kg using TRUVADA Low Strength Tablets
Body Weight (kg) Dosing of FTC (mg)/TDF (mg)
17 to less than 22 one 100/150 tablet once daily
22 to less than 28 one 133/200 tablet once daily
28 to less than 35 one 167/250 tablet once daily

2.3 Recommended Dose for Pre-exposure Prophylaxis

The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.4 Dose Adjustment for Renal Impairment

Treatment of HIV-1 Infection

Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment [see EMTRIVA or VIREAD Package Insert]. Therefore, adjust the dosing interval of TRUVADA in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 2. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects. The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions (5.3)] .

No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.

Table 2 Dosage Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance
Creatinine Clearance (mL/min) *
≥50 30–49 <30 (Including Patients Requiring Hemodialysis)
*
Calculated using ideal (lean) body weight
Recommended Dosing Interval Every 24 hours Every 48 hours TRUVADA should not be administered.

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment [see Warnings and Precautions (5.3)] .

Pre-exposure Prophylaxis

Do not use TRUVADA for a PrEP indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [see Warnings and Precautions (5.3)] .

Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment. If a decrease in estimated 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 [see Warnings and Precautions (5.3)] .

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