ISENTRESS® 400MG TABLET

Prescription Only

Drug type: Therapeutic

ATC code: J05AX08

Dosage form: TABLET, FILM COATED

Route of administration: ORAL

Active ingredient: Raltegravir potassium 434.4mg eqv free phenol; RALTEGRAVIR POTASSIUM 434.4 MG EQV FREE PHENOL

V. INDICATIONS

Adults

ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks.

The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response (see VIId. Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Pediatrics

ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older.

This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age (see VIId. Clinical Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

The safety and efficacy of ISENTRESS 400 mg tablets have not been established in children less than 6 years of age. The safety and efficacy of ISENTRESS chewable tablets have not been established in children less than 2 years of age.

VIII. CONTRAINDICATIONS

ISENTRESS is contraindicated in patients who are hypersensitive to any component of this medicine.

VI. DOSAGE AND ADMINISTRATION

ISENTRESS is to be given in a combination regimen with other antiretroviral agents.

ISENTRESS Film-coated Tablets and Chewable Tablets can be administered with or without food (see VII. Clinical Pharmacology – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

ISENTRESS is available in the following dose strengths:

600 mg film-coated tablet for once daily use
400 mg film-coated tablet for twice daily use
chewable tablet in 100 mg (scored) and 25 mg strengths for twice daily use.

Because the formulations have different pharmacokinetic profiles, do not substitute the 400 mg tablet for the 600 mg tablet to create a 1200 mg once daily dose and do not substitute the chewable tablet for the 400 mg or 600 mg tablet.

The maximum dose of the chewable tablet is 300 mg twice daily.

For the treatment of patients with HIV-1 infection, the dosage of ISENTRESS is as follows:

Adults:

Isentress Adult Dosing Recommendations Table