Simulect

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.

3 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.

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. 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. 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. 6.

Basiliximab has been tested in four randomised, double-blind, placebo-controlled studies in renal transplant recipients as an induction agent in combination with the following immunosuppressive regimens: ciclosporin for microemulsion and corticosteroids in two studies (346 and 380 patients), ciclosporin for microemulsion, azathioprine and corticosteroids in one study (340 patients), and ciclosporin for microemulsion, mycophenolate mofetil and corticosteroids in another study (123 patients).

Safety data in paediatric patients have been obtained from one open-label pharmacokinetic and pharmacodynamic study in renal transplant recipients (41 patients).

Incidence of adverse events:

In the above four placebo-controlled trials, the pattern of adverse events in 590 patients treated with the recommended dose of basiliximab was comparable to that observed in 595 patients treated with placebo. 6% - 39%) treatment groups.

6 Adult patients The most commonly reported (> 20%) events following dual or triple therapy in both treatment groups (basiliximab vs. placebo) were constipation, urinary tract infection, pain, nausea, peripheral oedema, hypertension, anaemia, headache, hyperkalaemia, hypercholesterolaemia, postoperative wound complication, weight increase, increase in blood creatinine, hypophosphataemia, diarrhoea and upper respiratory tract infection.

Paediatric population The most commonly reported (> 20%) events following dual therapy in both (< 35 kg vs.  35 kg weight) cohorts were urinary tract infection, hypertrichosis, rhinitis, pyrexia, hypertension, upper respiratory tract infection, viral infection, sepsis and constipation.

Incidence of malignant neoplasms:

The overall incidence of malignancies among all patients in the individual studies was similar between the basiliximab and the comparator treatment groups. 3% (2/595) of patients receiving placebo, both in combination with dual and triple immunosuppressive therapy.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Patients receiving Simulect must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.

Immunosuppressive regimens involving combinations of medications increase the susceptibility to infection, including opportunistic infections, fatal infections and sepsis; the risk increased with total immunosuppressive load. Simulect must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression.

4 Hypersensitivity reactions Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on re-exposure to a subsequent course of therapy. These included anaphylactoid-type reactions such as rash, urticaria, pruritus, sneezing, wheezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, cardiac failure, respiratory failure and capillary leak syndrome.

If a severe hypersensitivity reaction occurs, therapy with Simulect must be permanently discontinued and no further dose be administered. Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicinal product.

There is accumulating evidence that a subgroup of patients is at an increased risk of developing hypersensitivity reactions. These are patients in whom, following the initial administration of Simulect, the concomitant immunosuppression was discontinued prematurely due, for example, to abandoned transplantation or early loss of the graft.

Acute hypersensitivity reactions were observed on re-administration of Simulect for a subsequent transplantation in some of these patients. Neoplasms and infections Transplant patients receiving immunosuppressive regimens involving combinations with or without basiliximab are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus [CMV], BK virus).

1. 6).