Presentation

Emtifovir Tablet: Each tablet contains Emtricitabine INN 200 mg and Tenofovir Disoproxil Fumarate USP 300 mg.

Description

Emtifovir is the combination of Emtricitabine and Tenofovir Disoproxil Fumarate. Tenofovir Disoproxil Fumarate is converted in-vivo to Tenofovir. Emtricitabine and Tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase enzyme.

Indications

1.Treatment of HIV-1 infection (adults and children over 12 years of age): In combination with other antiretroviral agents

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

- Incarceration

- Partner(s) of unknown HIV-1 status with any of the factors listed above

Notes:

- 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.

Dosage & Administration

1. Treatment of HIV-1 infection (adults and children over 12 years of age): One tablet once daily taken orally with or without food

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.

Pre-exposure Prophylaxis:

Do not use Emtifovir for a Pre-Exposure Prophylaxis indication in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min.

Side Effects

- In HIV-1 infected subjects: The most common adverse reactions include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

- In HIV-1 uninfected adult subjects: No new adverse reactions were identified.

Precautions

Caution must be exercised when the following adverse reactions occur:

- 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

Use in Pregnancy & Lactation

Pregnancy Category B

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.

Drug Interaction

Co administration of Emtifovir and Didanosine, HIV-1 protease inhibitors or drugs affecting renal function (as Emtifovir is preliminarily excreted through urine) should be undertaken with caution.

Over Dose

If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.

Commercial Pack

Emtifovir Tablet: Each box contains 2 Alu-Alu blisters of 4 tablets.