Emtricitabine and Tenofovir Disoproxil Fumarate

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- emtricitabine and tenofovir disoproxil fumarate tablet
Golden State Medical Supply, Inc.

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION

Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued Emtricitabine and Tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue Emtricitabine and Tenofovir disoproxil fumarate tablets. If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1)].

Emtricitabine and Tenofovir disoproxil fumarate tablets used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of Emtricitabine and Tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate Emtricitabine and Tenofovir disoproxil fumarate tablets 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)].

1 INDICATIONS AND USAGE

1.1 Treatment of HIV-1 Infection

Emtricitabine and Tenofovir disoproxil fumarate tablet 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 Clinical Studies (14)].

1.2 HIV-1 Pre-Exposure Prophylaxis (PrEP)

Emtricitabine and Tenofovir disoproxil fumarate tablets are indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating Emtricitabine and Tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Testing Prior to Initiation of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for Treatment of HIV-1 Infection or for HIV-1 PrEP

Prior to or when initiating Emtricitabine and Tenofovir disoproxil fumarate tablets, test individuals for hepatitis B virus infection [see Warnings and Precautions (5.1)].

Prior to initiation and during use of Emtricitabine and Tenofovir disoproxil fumarate tablets, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.3)].

2.2 HIV-1 Screening for Individuals Receiving Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 PrEP

Screen all individuals for HIV-1 infection immediately prior to initiating Emtricitabine and Tenofovir disoproxil fumarate tablets for HIV-1 PrEP and at least once every 3 months while taking Emtricitabine and Tenofovir disoproxil fumarate tablets, and upon diagnosis of any other sexually transmitted infections (STIs) [see Indications and Usage (1.2), Contraindications (4) and Warnings and Precautions (5.2)].

If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection [see Warnings and Precautions (5.2), Use in Specific Populations (8.4), and Clinical Studies (14.3 and 14.4)].

2.3 Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg

Emtricitabine and Tenofovir disoproxil fumarate tablet is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The recommended dosage of Emtricitabine and Tenofovir disoproxil fumarate tablets in adults and in pediatric patients 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)].

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

The recommended oral dosage of Emtricitabine and Tenofovir disoproxil fumarate tablets for pediatric patients weighing at least 17 kg and who can swallow a tablet is presented in Table 1. Tablets should be taken once daily with or without food. Weight should be monitored periodically and the Emtricitabine and Tenofovir disoproxil fumarate tablets dose adjusted accordingly.

Table 1 Dosing for Treatment of HIV-1 Infection in Pediatric Patients Weighing 17 kg to less than 35 kg
Body Weight (kg) Dosing of Emtricitabine and Tenofovir disoproxil fumarate tablets (FTC/TDF)
17 to less than 22 one 100 mg /150 mg tablet once daily
22 to less than 28 one 133 mg /200 mg tablet once daily
28 to less than 35 one 167 mg /250 mg tablet once daily

2.5 Recommended Dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg

The dosage of Emtricitabine and Tenofovir disoproxil fumarate tablets for HIV-1 PrEP is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food in HIV-1 uninfected adults and adolescents weighing at least 35 kg [see Clinical Pharmacology (12.3)].

2.6 Dosage Adjustment in Individuals with Renal Impairment

Treatment of HIV-1 Infection

Table 2 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.

Table 2 Dosage Interval Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance
Creatinine Clearance (mL/min) a
≥50 30–49 <30 (Including Patients Requiring Hemodialysis)
Recommended Dosing Interval Every 24 hours Every 48 hours Emtricitabine and Tenofovir disoproxil fumarate tablet is not recommended.
a Calculated using ideal (lean) body weight

HIV-1 PrEP

Emtricitabine and Tenofovir disoproxil fumarate tablets 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 Emtricitabine and Tenofovir disoproxil fumarate tablets for HIV-1 PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [see Warnings and Precautions (5.3)].

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