INTELENCE TABLET 200 MG

TABLET

**Dosage and Administration** INTELENCE™ must always be given in combination with other antiretroviral medicinal products. **Adults** The recommended dose of INTELENCE™ is 200 mg (one 200mg tablet or two 100 mg tablets) taken orally twice daily (b.i.d.), following a meal (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Patients should be instructed to swallow the tablets as a whole with a liquid such as water. Patients who are unable to swallow the INTELENCE™ tablets whole may disperse the tablets in a glass of water. Once the tablets are dispersed, patients should stir the dispersion well, and drink it immediately. The glass should be rinsed with water several times, and each rinse completely swallowed to ensure the entire dose is consumed. **Children (less than 12 years of age) and adolescents (12 to 17 years of age)** Treatment with INTELENCE™ is not recommended in children and adolescents. The safety and efficacy of INTELENCE™ in these populations are under investigation (see _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Elderly** Limited information is available in this population (see _Warnings and Precautions_ and _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Pregnancy** No dose adjustment is required during pregnancy and postpartum. Given the increased etravirine exposure during pregnancy, caution should be applied for those pregnant patients that require concomitant medications or have comorbidities that may further increase etravirine exposure. **Hepatic impairment** No dose adjustment is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). The pharmacokinetics of INTELENCE™ have not been studied in patients with severe hepatic impairment (Child-Pugh score C) (see _Warnings and Precautions_ and _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal impairment** No dose adjustment is required in patients with renal impairment (see _Warnings and Precautions_ and _Pharmacokinetic Properties_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Missed doses** If the patient misses a dose of INTELENCE™ within 6 hours of the time it is usually taken, the patient should be told to take INTELENCE™ following a meal as soon as possible and then take the next dose of INTELENCE™ at the regularly scheduled time. If a patient misses a dose of INTELENCE™ by more than 6 hours of the time it is usually taken, the patient should be told not to take the missed dose and simply resume the usual dosing schedule.