Simulect Special Precautions

Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.
Patients receiving Simulect should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources including medications for the treatment of severe hypersensitivity reactions.
Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to Simulect and on reexposure to a subsequent course of therapy. These included anaphylactoid type reactions such as urticaria, pruritus, sneezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema, and respiratory failure. These reactions have been reported rarely for patients receiving Simulect (< 1/1000 patients). If severe hypersensitivity occurs, therapy with Simulect should be permanently discontinued and no further dose should be administered. Caution should be exercised when patients previously given Simulect are re-exposed to a subsequent course of therapy with this medicine.
There is accumulating evidence that a subgroup of patients is at 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.
Patients on immunosuppressive therapy following transplantation are at an increased risk of developing lymphoproliferative disorders (LPDs) and opportunistic infections. While Simulect is an immunosuppressive drug, to date no increase in LPDs or opportunistic infections has been observed in patients treated with Simulect. No differences were found in the incidence of malignancies and LPDs between Simulect and placebo in a pooled analysis of two five-year extension studies (see Adverse Reactions).
Effects on Ability to Drive and Use Machines: No studies on the effects on the ability to drive and use machines have been performed.
Simulect is not expected to affect the ability to drive or use machines.