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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
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