Posology : מינונים

4.2    Posology and method of administration

Therapy should be initiated by a physician experienced in the management of HIV infection.

Posology

INTELENCE must always be given in combination with other antiretroviral medicinal products.
Adults

The recommended dose of etravirine for adults is 200 mg (one 200mg tablet or two 100 mg tablets) taken orally twice daily, following a meal (see section 5.2).

Children (less than 12 years of age) and adolescents (12 to 17 years of age) Treatment with etravirine is not approved in Israel in children and adolescents.

Missed dose
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 INTELENCE tablet 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.


Elderly
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.

Hepatic impairment
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).

Renal impairment
No dose adjustment is required in patients with renal impairment (see section 5.2).

Method of administration
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.