Land: Zuid-Afrika
Taal: Engels
Bron: South African Health Products Regulatory Authority (SAHPRA)
Schering
MABCAMPATH SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): MABCAMPATH Solution for intravenous infusion COMPOSITION Each ampoule contains 30 mg alemtuzumab (10 mg/mL concentrate solution). PHARMACOLOGICAL CLASSIFICATION A. 26 Cytostatic agents. PHARMACOLOGICAL ACTION Pharmacodynamic properties Alemtuzumab is a genetically engineered humanised IgG1 kappa monoclonal antibody specific for a 21 to 28 kD lymphocyte cell surface glycoprotein (CD52) expressed primarily on the surface of normal and malignant peripheral blood B and T cell lymphocytes. Alemtuzumab was generated by the insertion of six complementarity-determining regions from an IgG2a rat monoclonal antibody into a human IgG1 immunoglobulin molecule. Alemtuzumab causes the lysis of lymphocytes by binding to CD52, a highly expressed, non-modulating antigen which is present on the surface of essentially all B and T cell lymphocytes as well as monocytes, thymocytes and macrophages. The antigen has also been found on a small percentage (<5%) of granulocytes, but not on erythrocytes or platelets. The antibody mediates the lysis of lymphocytes via complement fixation and antibody-dependent cell mediated cytotoxicity. Alemtuzumab does not appear to damage haematopoietic stem cells or progenitor cells. Pharmacokinetic properties The pharmacokinetics of alemtuzumab were studied in patients who received MabCampath once weekly for a maximum of 12 weeks. Following single intravenous infusions of 7,5 mg, 24 mg or 75 mg, the maximum serum concentration (C max ) and the area under the curve (AUC) showed relative dose proportionality. The median half-life ranged from ~ 23 to 30 hours. The pharmacokinetics and pharmacodynamics profile of MabCampath administered as a 30 mg intravenous infusion 3 times per week was evaluated in non-Hodgkin Lees het volledige document