TRUVADA ACCESS- emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Gilead Sciences, Inc
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION
Severe acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected patients who have discontinued TRUVADA. 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 [see Warnings and Precautions (5.1)].
TRUVADA used for HIV-1 PrEP 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 HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate TRUVADA for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.2)].
TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older [see Clinical Studies (14)].
TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. Individuals must have a negative HIV-1 test immediately prior to initiating TRUVADA for HIV-1 PrEP [see Dosage and Administration (2.2)].
- 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 cleared by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection [see Warnings and Precautions (5.2), Use in Specific Populations (8.4) and Clinical Studies (14.3, 14.4)].
When considering TRUVADA for HIV-1 PrEP, factors that help to identify individuals at risk may include:
- has partner(s) known to be HIV-1 infected, or
- engages in sexual activity within a high prevalence area or social network and has additional risk factors for HIV-1 acquisition, such as:
- 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
- partner(s) of unknown HIV-1 status with any of the factors listed above
Prior to or when initiating TRUVADA, test patients for hepatitis B virus infection [see Warnings and Precautions (5.1)].
Prior to initiation and during use of TRUVADA, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.3)].
Screen all patients for HIV-1 infection before initiating TRUVADA for HIV-1 PrEP and at least once every 3 months while taking TRUVADA [see Indications and Usage (1.2), Contraindications (4) and Warnings and Precautions (5.2)].
2.3 Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg
TRUVADA is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The recommended dosage of TRUVADA in adults and in pediatric patients 12 years of age and older with a body weight greater than or equal to 35 kg (greater than or equal to 77 lb) is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food [see Clinical Pharmacology (12.3)].
The dosage of TRUVADA in HIV-1 uninfected adults and adolescents 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 [see Clinical Pharmacology (12.3)].
Treatment of HIV-1 Infection
Table 1 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). The safety and effectiveness of the dosing interval adjustment recommendations in patients with moderate renal impairment (creatinine clearance 30–49 mL/min) have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions (5.3)].
No data are available to make dosage recommendations in pediatric patients with renal impairment.
|Creatinine Clearance (mL/min)*|
|≥50||30–49||<30(Including Patients Requiring Hemodialysis)|
|Recommended Dosing Interval||Every 24 hours||Every 48 hours||TRUVADA is not recommended.|
TRUVADA for HIV-1 PrEP is not recommended in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [see Warnings and Precautions (5.3)].
If a decrease in estimated creatinine clearance is observed in uninfected individuals while using TRUVADA for HIV-1 PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [see Warnings and Precautions (5.3)].
TRUVADA is available as tablets. Each tablet contains 200 mg of emtricitabine and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil). The tablets are light blue, capsule-shaped, film-coated, debossed with “GILEAD” on one side.
TRUVADA for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)].
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