INTELENCE TABLET 200 MG [SIN14535P]

Product Info

INTELENCE TABLET 200 MG

[SIN14535P]

Indications
INTELENCE™, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.

This indication is based on week 48 analyses from 2 randomised, double-blind, placebo-controlled trials of INTELENCE™. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.
The following points should be considered when initiating therapy with INTELENCE™:

• Treatment history, and, when available, resistance testing, should guide the use of INTELENCE™.

• The use of other active antiretroviral agents with INTELENCE™ is associated with an increased likelihood of treatment response.

• In patients who have experienced virologic failure on an NNRTI-containing regimen, do not use INTELENCE™ in combination with only N[t]RTIs (see Pharmacodynamic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• The risks and benefits of INTELENCE™ have not been established in pediatric patients or in treatment naïve adult patients.

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.

Contraindications
Hypersensitivity to etravirine or to any of the excipients.