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 instructions on reconstitution of the medicinal product before administration, see section 6.6.

 

4.3 Contraindications

 

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

 

Pregnancy and lactation (see section 4.6).

 

4.4 Special warnings and precautions for use

 

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.

 

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). In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without Simulect. In a pooled analysis of two five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without combination of basiliximab (see section 4.8).