ISENTRESS Film-coated tablet Ref.[8806] Active ingredients: Raltegravir

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

Posology

ISENTRESS should be used in combination with other active anti-retroviral therapies (ARTs) (see sections 4.4 and 5.1).

Adults and paediatric population

In adults and paediatric patients (weighing at least 40 kg), the recommended dosage is 1,200 mg (two 600 mg tablets) once daily for treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily.

Additional formulations and strengths available

ISENTRESS is also available as a 400 mg tablet for twice daily use in HIV infected adults or children and adolescents at least 25 kg. The 400 mg tablet should not be used to administer 1,200 mg once daily regimen (please refer to the 400 mg Summary of Product Characteristics).

ISENTRESS is also available in a chewable tablet formulation and in granules for oral suspension formulation. Refer to the chewable tablet and granules for oral suspension SmPCs for additional dosing information. The safety and efficacy of raltegravir in preterm (<37 weeks of gestation) and low birth weight (<2000 g) newborns have not been established. No data are available in this population and no dosing recommendations can be made.

The maximum dose of the chewable tablet is 300 mg twice daily. Because the formulations have different pharmacokinetic profiles neither the chewable tablets nor the granules for oral suspension should be substituted for the 400 mg tablet or the 600 mg tablet (see section 5.2). The chewable tablets and the granules for oral suspension have not been studied in HIV-infected adolescents (12 to 18 years) or adults.

Elderly

There is limited information regarding the use of raltegravir in the elderly (see section 5.2). Therefore, ISENTRESS should be used with caution in this population.

Renal impairment

No dosage adjustment is required for patients with renal impairment (see section 5.2).

Hepatic impairment

No dosage adjustment is required for patients with mild to moderate hepatic impairment. The safety and efficacy of raltegravir have not been established in patients with severe underlying liver disorders. Therefore, ISENTRESS should be used with caution in patients with severe hepatic impairment (see sections 4.4 and 5.2).

ISENTRESS 600 mg film-coated tablet formulation should not be used in children weighing less than 40 kg.

Method of administration

Oral use.

ISENTRESS 600 mg tablets can be administered with or without food as a 1,200 mg once daily dose. The tablets should not be chewed, crushed or split due to anticipated changes in the pharmacokinetic profile.

No specific information is available on the treatment of overdose with raltegravir.

In the event of an overdose, it is reasonable to employ the standard supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring (including obtaining an electrocardiogram), and institute supportive therapy if required. It should be taken into account that raltegravir is presented for clinical use as the potassium salt. The extent to which raltegravir may be dialysable is unknown.

2 years.

Keep the bottle tightly closed, with the desiccant in order to protect from moisture.

High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure, induction seal and silica gel dessicant.

Two pack sizes are available: 1 bottle with 60 tablets, and a multipack containing 180 (3 bottles of 60) tablets.

Not all pack sizes may be marketed.

No special requirements for disposal.