SIMULECT

What it is

Simulect contains 20 mg basiliximab as a sterile freeze-dried powder for reconstitution with water for injections. Basiliximab is a murine/human chimeric monoclonal antibody (IgG1K) that is directed against the interleukin-2 receptor alpha-chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge. Basiliximab specifically binds to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor and thereby prevents binding of interleukin-2, the signal for T-cell proliferation.

Approved indications

— Prophylaxis of acute organ rejection in renal transplantation.

Dosing overview

The adult dose of Simulect is 40 mg, given as two 20 mg doses, by intravenous injection. The first 20 mg dose is given within 2 hours prior to transplantation surgery. The second 20 mg dose is given 4 days after transplantation. The second dose should be withheld if severe hypersensitivity reactions to Simulect or post-operative complications such as graft loss occur. In paediatric patients weighing less than 35 kg, the recommended total dose of Simulect 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. Simulect is reconstituted and administered either as an intravenous infusion over 20 to 30 minutes or as a bolus injection.

Key safety warnings

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. Patients receiving Simulect should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Medications for treatment of hypersensitivity should be available for immediate use (e.g. adrenaline). Transplant patients receiving immunosuppressive regimens involving combinations with or without Simulect are at an increased risk of developing cancer and lymphoproliferative disorders (such as lymphoma). Transplant patients receiving immunosuppressive regimens involving combinations with or without Simulect are at an increased risk of developing opportunistic infections (such as cytomegalovirus, CMV) and should be appropriately monitored. The efficacy and safety of Simulect for the prophylaxis of acute rejection in recipients of solid organ allographs other than renal have not been demonstrated. In several small clinical trials in heart transplant recipients, serious cardiac adverse events such as cardiac arrest (2.2%), atrial flutter (1.9%) and palpitations (1.4%) have been reported more frequently with Simulect than with other induction agents.

Contraindications

Simulect is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation.

PBS listing

No information regarding PBS listing is provided in the source documents.

Regulatory history

Simulect basiliximab 20 mg powder for injection vial and diluent ampoule was first listed on the ARTG on 18 February 1999. A new presentation, Simulect basiliximab 20 mg powder for injection vial (without diluent ampoule), was first listed on the ARTG on 22 October 2024.