Basiliximab
- CAS Number: 179045-86-4
Basiliximab is a chimeric monoclonal antibody against the interleukin -2 receptor ( CD25 ), which is used therapeutically in the prevention of acute rejection after renal and hepatic transplantation.
- 2.1 Mechanism of action ( pharmacodynamics ) 2.1.1 Toxicology
- 3.1 Chemical Information
- 3.2 History
Clinical information
Areas of application (indications )
Basiliximab is used in adults and children in combination with ciclosporin and corticosteroids for disease prevention of acute graft rejection after kidney transplants. In adults, it can also be used as part of an immunosuppressive treatment duration in combination with cyclosporine, corticosteroids and azathioprine or mycophenolate mofetil.
Currently, clinical trials for the treatment of ulcerative colitis are performed with basiliximab, for this indication, however, is currently not approved before.
Posology and method of administration
Once ensure that the patient receives the transplant can be administered intravenously two hours prior to the 20 mg basiliximab transplantation in adults. Four days after the transplantation, followed by a further dose of 20 mg.
Contraindications ( contraindications)
Basiliximab may be used either with a known hypersensitivity to the antibody during pregnancy and lactation.
Adverse effects (side effects)
Basiliximab leads to a variety of side effects; be in addition to very frequent, such as pain or nausea, though rarely, observed hypersensitivity reactions, which may be severe. Therefore, the use of the antibody may occur only in hospitals that are able to deal with such hypersensitivity reactions. An increased number of infectious diseases, or malignant disease was not observed.
Pharmacological properties
Mechanism of action ( pharmacodynamics )
Basiliximab binds and blocks the IL -2 receptor ( CD25 ) on the surface of activated T-lymphocytes. Characterized the signal for T -cell proliferation is interrupted and weakened immune response against the transplant. In clinical studies in a total of 590 patients could be shown that supplementing a standard immunosuppressive treatment with basiliximab leads to a reduced number of acute transplant rejection. Another drug with the same mechanism of action is the humanized antibody daclizumab.
Toxicology
In rhesus monkeys showed single doses up to 5 mg / kg and multiple doses up to 24 mg / kg ( more than a thousand times the exposure according to the clinically recommended dose) no adverse effects. In clinical studies, 60 mg as a single dose and 150 mg multiple doses no adverse effects.
Other Information
Chemical information
Basiliximab is a chimeric ( mouse / human ) antibody IgG1 produced in mouse myeloma cells in cell culture. The finished medicinal product also contains as excipients potassium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride, sucrose, mannitol, glycine, and water for injections.
History
The antibody was approved in May 1998 in the U.S. and in October 1998 in the European Union.