Emtricitabine + Tenofovir Disoproxil Fumarate is indicated for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older in combination with other antiretroviral agents.

HIV

Treatment of HIV-1 Infection

• Recommended dose in adults and pediatric patients (12 years of age and older and weighing greater than or equal to 35 kg): One tablet once daily taken orally with or without food.
• Recommended dose in renally impaired HIV-1 infected adult patients:
• Creatinine clearance 30-49 mL/min: 1 tablet every 48 hours. 
• CrCl below 30 mL/min or hemodialysis: Do not use.

Pre-exposure Prophylaxis

• Recommended dose in HIV-1 uninfected adults: One tablet once daily taken orally with or without food. 
• Recommended dose in renally impaired HIV-uninfected individuals: Do not use Emtricitabine + Tenofovir Disoproxil Fumarate in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using Emtricitabine + Tenofovir Disoproxil Fumarate for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use.

The most common adverse reactions associated with Emtricitabine + Tenofovir Disoproxil Fumarate are-

• diarrhea
• nausea
• fatigue
• headache
• dizziness
• depression
• insomnia
• abnormal dreams
• rash

Diarrhea	Nausea	Fatigue
Headache	Dizziness	Depression

• The use of nucleoside analogs, including Tenofovir, a component of Emtricitabine + Tenofovir Disoproxil Fumarate, has been linked to lactic acidosis and severe hepatomegaly with steatosis, including fatal cases.
• Emtricitabine + Tenofovir Disoproxil Fumarate has not been approved to treat chronic hepatitis B virus (HBV) infection. Severe acute hepatitis B exacerbations have been reported in patients with HIV-1 and HBV who have stopped taking Emtricitabine + Tenofovir Disoproxil Fumarate. As a result, in HBV-infected patients who stop taking Emtricitabine + Tenofovir Disoproxil Fumarate, hepatic function should be closely monitored. If appropriate, anti-hepatitis B therapy may be initiated.
• Emtricitabine + Tenofovir Disoproxil Fumarate for PrEP (pre-exposure prophylaxis) use should only be prescribed to individuals who have been confirmed to be HIV-negative both before and during use. With the use of Emtricitabine + Tenofovir Disoproxil Fumarate for a PrEP indication following undetected acute HIV-1 infection, drug-resistant HIV-1 variants have been identified. If signs or symptoms of acute HIV infection are present, do not start Emtricitabine + Tenofovir Disoproxil Fumarate for a PrEP indication unless a negative infection status is confirmed.
• New onset or worsening renal impairment: Acute renal failure and Fanconi syndrome are two examples. Before beginning Emtricitabine + Tenofovir Disoproxil Fumarate treatment, determine your creatinine clearance (CrCl). In high-risk patients, keep an eye on CrCl and serum phosphorus levels. Avoid taking Emtricitabine + Tenofovir Disoproxil Fumarate if you are currently taking or have recently taken a nephrotoxic medication.
• Decreases in bone mineral density: Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss.
• Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy.
• Immune reconstitution syndrome: May necessitate further evaluation and treatment.
• Triple nucleoside-only regimens: Early virologic failure has been reported in HIV-infected patients. Monitor carefully and consider treatment modification.
• Comprehensive management to reduce the risk of acquiring HIV-1: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule.
• Management to reduce the risk of acquiring HIV-1 drug resistance: If clinical symptoms consistent with acute viral infection are present and recent (1 month) exposures are suspected, delay starting Emtricitabine + Tenofovir Disoproxil Fumarate for at least one month and reconfirm negative 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.