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Emtricitabine (In combo with Truvada for HIV)

Brand and Other Names: Truvada
Mechanism of Action:
TRUVADA is a fixed-dose combination of antiviral drugs FTC and TDF
Indications:

HIV-1 Treatment TRUVADA is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and 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.
HIV-1 PrEP :
• TRUVADA is 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 TRUVADA for HIV-1 PrEP. See package insert for complete information.

Route: Oral
Dose:

• Recommended dosage in adults and pediatric patients weighing at least 35 kg: One TRUVADA tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.
• Recommended dosage in pediatric patients weighing at least 17 kg: One TRUVADA low-strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food.
• Recommended dosage in renally impaired HIV-1 infected adult patients:

Adverse Reactions:

• In HIV-1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.
• In HIV-1 uninfected adults in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased.

Contraindication:
TRUVADA for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
Warnings and Precautions:

• Comprehensive management to reduce the risk of acquiring HIV-1 when TRUVADA is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to the dosing schedule.
• Management to reduce the risk of acquiring HIV-1 drug resistance when TRUVADA is used for HIV-1 PrEP: refer to full prescribing information for additional details.
• New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Avoid administering TRUVADA with concurrent or recent use of nephrotoxic drugs.
• Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment.
• Decreases in bone mineral density (BMD): Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. See package insert for complete information.

See package insert for full prescribing information.