Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (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 Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).
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.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Emtriva 200 mg hard capsules may be taken with or without food.
The recommended dose of Emtriva is one 200 mg hard capsule, taken orally, once daily.
If a patient misses a dose of Emtriva within 12 hours of the time it is usually taken, the patient should take Emtriva with or without food as soon as possible and resume their normal dosing schedule. If a patient misses a dose of Emtriva 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 Emtriva, another dose should be taken. If the patient vomits more than 1 hour after taking Emtriva 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.
Emtricitabine is eliminated by renal excretion and exposure to emtricitabine was significantly increased in patients with renal insufficiency (see section 5.2). Dose or dose interval adjustment is required in all patients with creatinine clearance <30 ml/min (see section 4.4).
Table 1 below provides dose interval adjustment guidelines for the 200 mg hard capsules according to the degree of renal insufficiency. The safety and efficacy of the dose interval adjustments to every 72 or 96 hours in patients with creatinine clearance <30 ml/min have not been clinically evaluated. Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see section 4.4).
Patients with renal insufficiency can also be managed by administration of Emtriva 10 mg/ml oral solution to provide a reduced daily dose of emtricitabine. Please refer to the Summary of Product Characteristics for Emtriva 10 mg/ml oral solution.
Table 1. Dose interval guidelines for 200 mg hard capsules adjusted according to creatinine clearance:
| Creatinine Clearance (CLcr) (ml/min) | |||
|---|---|---|---|
| ≥30 | 15-29 | <15 (functionally anephric, requiring intermittent haemodialysis)* | |
| Recommended dose interval for 200 mg hard capsules | One 200 mg hard capsule every 24 hours | One 200 mg hard capsule every 72 hours | One 200 mg hard capsule every 96 hours |
* Assumes a 3h haemodialysis session three times a week commencing at least 12h after administration of the last dose of emtricitabine.
Patients with end-stage renal disease (ESRD) managed with other forms of dialysis such as ambulatory peritoneal dialysis have not been studied and no dose recommendations can be made.
No data are available on which to make a dose recommendation for patients with hepatic insufficiency. However, based on the minimal metabolism of emtricitabine and the renal route of elimination it is unlikely that a dose adjustment would be required in patients with hepatic insufficiency (see section 5.2).
If Emtriva is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
The recommended dose of Emtriva for children aged 4 months and over and adolescents up to 18 years of age weighing at least 33 kg who are able to swallow hard capsules is one 200 mg hard capsule, taken orally, 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 Emtriva is not recommended for use in those aged less than 4 months (for pharmacokinetic data in this age group, see section 5.2).
No data are available on which to make a dose recommendation in paediatric patients with renal insufficiency.
Emtriva 200 mg hard capsules should be taken once daily, orally with or without food.
Emtriva is also available as a 10 mg/mL oral solution for use in infants aged 4 months and over, children and patients who are unable to swallow hard capsules and patients with renal insufficiency. Please refer to the Summary of Product Characteristics for Emtriva 10 mg/mL oral solution. 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 should provide similar plasma levels to those observed after administration of one 200 mg emtricitabine hard capsule (see section 5.2).
Administration of up to 1,200 mg emtricitabine has been associated with the adverse reactions listed above (see section 4.8).
If overdose occurs, the patient should be monitored for signs of toxicity and standard supportive treatment applied as necessary.
Up to 30% of the emtricitabine dose can be removed by haemodialysis. It is not known whether emtricitabine can be removed by peritoneal dialysis.
Bottle: 4 years.
Blister: 3 years.
This medicinal product does not require any special storage conditions.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure, containing 30 hard capsules.
Blisters made of polychlorotrifluorethylene (PCTFE)/polyethylene (PE)/polyvinylchloride (PVC)/aluminium. Each blister pack contains 30 hard capsules.
Pack size: 30 hard capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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