Simulect 10mg and 20mg powder and solvent for solution for injection or infusion

Therapeutic indications

Simulect is indicated for the prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

Posology and method of administration

Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Simulect should be administered under qualified medical supervision.

Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.

Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression. It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple immunosuppressive regimen including azathioprine or mycophenolate mofetil.

Posology

Adults

The standard total dose is 40 mg, given in two doses of 20 mg each.

The first 20 mg dose should be given within 2 hours prior to transplantation surgery. The second 20 mg dose should be given 4 days after transplantation. The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).

Children and adolescents (1–17 years)

In paediatric patients weighing less than 35 kg, the recommended total dose is 20 mg, given in two doses of 10 mg each. In paediatric patients weighing 35 kg or more, the recommended dose is the adult dose, i.e. a total dose of 40 mg, given in two doses of 20 mg each.

The first dose should be given within 2 hours prior to transplantation surgery. The second dose should be given 4 days after transplantation. The second dose should be withheld in the event of a severe hypersensitivity reaction to Simulect or post-operative complications such as graft loss (see section 4.4).

Elderly ( ≥ 65 years)

There are limited data available on the use of Simulect in the elderly, but there is no evidence that elderly patients require a different dosage from younger adult patients.

Method of administration

Reconstituted Simulect can be administered as an intravenous bolus injection or as an intravenous infusion over 20–30 minutes.

For information on reconstitution, see section 6.6.

Overdose

In clinical studies basiliximab has been administered to humans in single doses of up to 60 mg and multiple doses of up to 150 mg over 24 days with no acute undesirable effects.

For information on preclinical toxicology see section 5.3.

Shelf life

Powder: 3 years.

Chemical and physical stability of the reconstituted solution is demonstrated for 24 hours at 2°C – 8°C or for 4 hours at room temperature (see section 6.6).

Special precautions for storage

Store and transport refrigerated (2°C – 8°C).

Nature and contents of container

Simulect powder

Colourless type I glass vial, grey fluor-resin coated butyl rubber stopper, held in place by a flanged aluminium band, blue polypropylene flip-off cap, containing 10 mg / 20 mg basiliximab as powder for solution for injection or infusion.

Solvent

Colourless glass ampoule, type I glass, containing 5 ml water for injections.

Simulect is also available in vials with 10 mg / 20 mg basiliximab.

Special precautions for disposal and other handling

Simulect 10 mg powder and solvent for solution for injection or infusion

Reconstitution: To prepare the solution for infusion or injection, take 2.5 ml of water for injections out of the accompanying 5 ml-ampoule aseptically and add this 2.5 ml of water for injections aseptically to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder, avoiding foaming. It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately. Reconstituted products should be inspected visually for particulate matter prior to administration. Do not use if foreign particles are present. After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C – 8°C or for 4 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Discard the reconstituted solution if not used within 24 hours.

The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 25 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.

Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.

Compatibility with a number of infusion sets has been verified.

Any unused product or waste material should be disposed of in accordance with local requirements.

Simulect 20 mg powder and solvent for injection or infusion

Reconstitution: To prepare the solution for infusion or injection, add 5 ml of water for injections from the accompanying ampoule aseptically to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder, avoiding foaming. It is recommended that after reconstitution the colourless, clear to opalescent solution should be used immediately. Reconstituted products should be inspected visually for particulate matter prior to administration. Do not use if foreign particles are present. After reconstitution, chemical and physical in-use stability has been demonstrated for 24 hours at 2°C – 8°C or for 4 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Discard the reconstituted solution if not used within 24 hours.

The reconstituted solution is isotonic and may be given as a bolus injection or diluted to a volume of 50 ml or greater with normal saline or dextrose 50 mg/ml (5%) for infusion.

Since no data are available on the compatibility of Simulect with other medicinal products intended for intravenous administration, Simulect should not be mixed with other medicinal products and should always be given through a separate infusion line.

Compatibility with a number of infusion sets has been verified.

Any unused product or waste material should be disposed of in accordance with local requirements.