Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and in antiretroviral treatment-experienced paediatric patients from 6 years of age (see sections 4.4, 4.5 and 5.1).
Therapy should be initiated by a physician experienced in the management of HIV infection.
INTELENCE must always be given in combination with other antiretroviral medicinal products.
The recommended dose of etravirine for adults is 200 mg (one 200 mg tablet or two 100 mg tablets) taken orally twice daily following a meal (see section 5.2).
The recommended dose of etravirine for paediatric patients (6 years to less than 18 years of age and weighing at least 16 kg) is based on body weight (see table below). INTELENCE tablet(s) should be taken orally, following a meal (see section 5.2).
Recommended dose of etravirine for paediatric patients 6 years to less than 18 years of age:
| Body weight | Dose | Tablets |
|---|---|---|
| ≥16 to <20 kg | 100 mg twice daily | four 25 mg tablets twice daily or one 100 mg tablet twice daily |
| ≥20 to <25 kg | 125 mg twice daily | five 25 mg tablets twice daily or one 100 mg tablet and one 25 mg tablet twice daily |
| ≥25 to <30 kg | 150 mg twice daily | six 25 mg tablets twice daily or one 100 mg tablet and two 25 mg tablets twice daily |
| ≥30 kg | 200 mg twice daily | eight 25 mg tablets twice daily or two 100 mg tablets twice daily or one 200 mg tablet twice daily |
If the patient misses a dose of INTELENCE within 6 hours of the time it is usually taken, the patient should take it following a meal as soon as possible and then take the next dose at the regularly scheduled time. If a patient misses a dose by more than 6 hours of the time it is usually taken, the patient should not take the missed dose and simply resume the usual dosing schedule.
If a patient vomits within 4 hours of taking the medicine, another dose of INTELENCE should be taken following a meal as soon as possible. If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose until the next regularly scheduled time.
There is limited information regarding the use of INTELENCE in patients >65 years of age (see section 5.2), therefore caution should be used in this population.
No dose adjustment is suggested in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B); INTELENCE should be used with caution in patients with moderate hepatic impairment. The pharmacokinetics of etravirine have not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Therefore, INTELENCE is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
No dose adjustment is required in patients with renal impairment (see section 5.2).
The safety and efficacy of etravirine in children less than 6 years of age and weighing less than 16 kg have not yet been established (see section 5.2). No data are available.
Oral use.
Patients should be instructed to swallow the tablet(s) whole with a liquid such as water. Patients who are unable to swallow the tablet(s) whole may disperse the tablet(s) in a glass of water.
For instructions on dispersion of the medicinal product before administration, see section 6.6.
There are no data with regard to symptomatic overdose with etravirine, but it is possible that the most frequent adverse reactions of etravirine, i.e. rash, diarrhoea, nausea, and headache would be the most common symptoms noted. There is no specific antidote for overdose with etravirine. Treatment of overdose with INTELENCE consists of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. Since etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
INTELENCE 25 mg tablets: 2 years.
8 weeks after opening the bottle.
INTELENCE 100 mg tablets: 2 years.
INTELENCE 200 mg tablets: 2 years.
6 weeks after opening the bottle.
Store in the original bottle and keep the bottle tightly closed in order to protect from moisture. Do not remove the desiccant pouches.
INTELENCE 25 mg tablets: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 2 desiccant pouches, fitted with a polypropylene (PP) child resistant closure. Each carton contains one bottle.
INTELENCE 100 mg tablets: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 120 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure. Each carton contains one bottle.
INTELENCE 200 mg tablets: The bottle is a high-density polyethylene (HDPE) plastic bottle containing 60 tablets and 3 desiccant pouches, fitted with a polypropylene (PP) child resistant closure. Each carton contains one bottle.
Patients who are unable to swallow the tablet(s) whole may disperse the tablet(s) in a glass of water.
The patient should be instructed to do the following:
The use of warm (>40°C) or carbonated beverages should be avoided.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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