Emtifovir Tablet: Each tablet contains Emtricitabine INN 200 mg and Tenofovir Disoproxil Fumarate USP 300 mg.
2. Pre-Exposure Prophylaxis (adults): In combination with safer sex, practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk.
For pre-exposure prophylaxis, the following factors may help to identify individuals at high risk:
- Has partner(s) known to be HIV-1 infected, or engages in sexual activity within a high prevalence area or social network and one or more of the following:
- 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
- A negative HIV-1 test should immediately be confirmed prior to initiating Emtifovir for a pre-exposure prophylaxis indication.
- Screening for HIV-1 infection should be performed at least once every 3 months while taking Emtifovir for pre-exposure prophylaxis.
2. Pre-Exposure Prophylaxis (adults): One tablet once daily taken orally with or without food
Dose adjustment for renal impairment:
Creatinine Clearance : Recommended Dosing Interval
≥ 50 mL/min : Every 24-hour
30-49 mL/min : Every 48-hour
< 30 mL/min : Should not be administered
(Including the patient requiring Hemodialysis)
Routine monitoring of estimated creatinine clearance, serum phosphorus, urine glucose, and urine protein should be performed in all individuals with mild renal impairment.
Do not use Emtifovir for a Pre-Exposure Prophylaxis indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min.
- In HIV-1 uninfected adult subjects: No new adverse reactions were identified.
- Lactic Acidosis/Severe Hepatomegaly with Steatosis: Treatment should be suspended in any patient who develops lactic acidosis or hepatotoxicity
- Severe Acute Exacerbations of hepatitis B: Severe acute exacerbations of hepatitis B have been reported in patients who are co infected with HBV and HIV-1 and have discontinued Emtifovir
- New Onset or Worsening Renal Impairment
- Immune Reconstitution Syndrome
- Changes in Bone Mineral Density
Emtifovir has been evaluated in a limited number of women during pregnancy. Emtifovir should be used during pregnancy only if clearly needed.
Emtricitabine and Tenofovir are excreted in human milk. Mothers should be instructed not to breast-feed if they are receiving Emtifovir.