Active Ingredient: Emtricitabine
Emtricitabine is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults and children aged 4 months and over.
This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control. There is no experience of the use of emtricitabine in patients who are failing their current regimen or who have failed multiple regimens.
When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Capsule oral, 200 milligrams emtricitabine, once daily.
Regimen B: Solution oral, 240 milligrams emtricitabine, once daily.
The recommended dose of emtricitabine is one 200 mg hard capsule or 240 mg (24 mL) of 10 mg/mL oral solution, taken orally, once daily.
Due to a difference in the bioavailability of emtricitabine between the hard capsule and oral solution presentations, 240 mg emtricitabine administered as the oral solution (24 mL) should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule.
If a patient misses a dose of emtricitabine within 12 hours of the time it is usually taken, the patient should take emtricitabine with or without food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of emtricitabine by more than 12 hours and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking emtricitabine, another dose should be taken. If the patient vomits more than 1 hour after taking emtricitabine they do not need to take another dose.
There are no safety and efficacy data available in patients over the age of 65 years. However, no adjustment in the recommended daily dose for adults should be required unless there is evidence of renal insufficiency.
It may be taken with or without food.
For:
Regimen A: In case that patient age in months is ≥ 4 and patient weight is ≥ 33 kg, capsule oral, 200 milligrams emtricitabine, once daily.
Regimen B: In case that patient age in months is ≥ 4 and patient weight is ≥ 33 kg, solution oral, 6 milligrams emtricitabine per kilogram of body weight, once daily.
The recommended dose of emtricitabine 10 mg/mL oral solution is 6 mg/kg up to a maximum of 240 mg (24 mL) once daily.
Children aged 4 months and over, who weigh at least 33 kg may either take 200 mg as hard capsule daily or may take emtricitabine as the oral solution up to a maximum of 240 mg once daily.
There are no data regarding the efficacy and only very limited data regarding the safety of emtricitabine in infants below 4 months of age. Therefore emtricitabine is not recommended for use in those aged less than 4 months.
No data are available on which to make a dose recommendation in paediatric patients with renal insufficiency.
It may be taken with or without food.
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