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

1. Name of the medicinal product

 

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

 

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

 

2. Qualitative and quantitative composition

 

Each vial contains 10 or 20 mg basiliximab*.

 

One ml of the reconstituted solution contains 4 mg basiliximab.

 

* recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor α-chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology.

 

For the full list of excipients, see section 6.1.

 

3. Pharmaceutical form

 

Powder and solvent for solution for injection or infusion

 

White powder

 

4. Clinical particulars

 

4.1 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.

 

4.2 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).