EMTRICITABINE 200 mg + TENOFOVIR DISOPROXIL FUMARATE 300 mg Tablets

Fixed-Dose NRTI Backbone – HIV Treatment & Pre-Exposure Prophylaxis (PrEP)

ATC Code: J05AR03 | Prescription Only | WHO Essential Medicine

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Product Description:

This fixed-dose combination tablet contains two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs):

• Emtricitabine (FTC): A cytidine analog with potent antiviral activity against HIV-1
• Tenofovir Disoproxil Fumarate (TDF): A prodrug of tenofovir, an adenosine nucleotide analog that inhibits HIV reverse transcriptase and HBV polymerase

Together, they form a potent once-daily antiretroviral backbone used in both HIV treatment and prevention. It is also a key component in fixed-dose combinations such as TDF/FTC/EFV or TDF/FTC/DTG, and is frequently used in Post-Exposure Prophylaxis (PEP) and Pre-Exposure Prophylaxis (PrEP).

Available Presentation:

• Strength per Tablet: Emtricitabine 200 mg + Tenofovir Disoproxil Fumarate 300 mg
• Formulation: Film-coated tablet
• Packaging: Bottle of 30 tablets
• Route of Administration: Oral, once daily
• Storage Conditions: Store below 30°C; protect from light and moisture

Uses:

• As part of a 3-drug regimen for HIV-1 treatment in adults and adolescents
• As a complete 2-drug regimen for PrEP in HIV-negative individuals at high risk of infection
• Used extensively in:
  • PEPFAR-supported national treatment programs
  • PrEP rollout initiatives in public health systems
  • Transitioning virally suppressed patients to simplified fixed-dose regimens

Indications:

• Treatment of HIV-1 infection in combination with other antiretroviral agents in adults and pediatric patients ≥12 years and ≥35 kg
• Pre-Exposure Prophylaxis (PrEP): To reduce the risk of sexually acquired HIV-1 in at-risk HIV-negative individuals
• Post-Exposure Prophylaxis (PEP): In occupational and non-occupational settings, combined with a third agent (e.g., dolutegravir)

Regulatory and Safety Profile:

• ATC Code: J05AR03
• Pharmacologic Class: NRTI Fixed-Dose Combination
• Pregnancy Category: B – Widely used and considered safe in pregnancy
• Black Box Warnings:
  • Hepatitis B reactivation risk upon discontinuation in co-infected patients
  • Lactic acidosis and hepatomegaly with steatosis, rare but serious
• Common Adverse Effects: Nausea, fatigue, headache, dizziness, diarrhea
• Serious Risks: Renal toxicity (Fanconi syndrome), bone mineral loss, hepatotoxicity
• Contraindications: Known hypersensitivity to FTC or TDF, severe renal impairment (CrCl <30 mL/min)
• Monitoring Parameters: HIV status (to rule out acute infection before PrEP), renal function, hepatitis B co-infection, adherence, bone density (if at risk)

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For programmatic orders, regulatory submissions, or inclusion in PrEP and PEP formularies, contact info@panamfarma.com.