Emtricitabine + Tenofovir Disoproxil Fumarate
Treatment of HIV-1 infection (adults and children over 12 years of age): In combination with other antiretroviral agents
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.
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 Emtricitabine for a pre-exposure prophylaxis indication.
Screening for HIV-1 infection should be performed at least once every 3 months while taking Emtricitabine for pre-exposure prophylaxis.
Drugs for HIV / Anti-retroviral drugs
Tenofovir disoproxil fumarate, a diester prodrug of tenofovir, is rapidly converted to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analogue of adenosine 5′-monophosphate while emtricitabine is a synthetic nucleoside analogue of cytidine. Both emtricitabine and tenofovir inhibit HIV-1 reverse transcriptase, resulting in DNA chain termination.
Dosage & Administration
Adult ≥18 yr: As tablet containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate: 1 tablet once daily. For patients with swallowing difficulties, tablet may be disintegrated in approx 100 ml of water, orange juice or grape juice and consumed immediately.
Recommended Dosing Interval-
- CrCl ≥ 50 ml/min: Every 24-hour
- CrCl 30-49 mL/min: Every 48-hour
- CrCl < 30 mL/min: Should not be administered
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.
Decreased atazanavir concentration with tenofovir unless also co-administered with ritonavir. Increased serum concentration of both tenofovir and emtricitabine or co-administered drug if taken with drugs that are eliminated by active tubular secretion.
Do not use Emtricitabine and Tenofovir for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. This should be used in HIV-infected patients only in combination with other antiretroviral agents.
Nausea, vomiting, diarrhoea, abdominal pain, dyspepsia, flatulence, pain, hypersensitivity, increased pigmentation, asthenia, osteonecrosis, osteomalacia, metabolic abnormalities, lipodystrophy, elevated lipase, amylase, creatine kinase or transaminases levels, hyperbilirubinaemia, insomnia, abnormal dreams. Neutropenia, anaemia, Immune Reactivation Syndrome. Renal impairment, acute renal failure, Fanconi syndrome.
Pregnancy & Lactation
Pregnancy Category B. Tenofovir and Emtricitabine has been evaluated in a limited number of women during pregnancy. This 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 this.
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
If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary.
Store between 15-30° C