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Alemtuzumab

Generic Name
Alemtuzumab
Brand Names
Campath, Lemtrada, MabCampath
Drug Type
Biotech
CAS Number
216503-57-0
Unique Ingredient Identifier
3A189DH42V

Overview

Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.

Background

Alemtuzumab is a humanized monoclonal antibody specific to lymphocyte antigens. It is a recombinant DNA-derived humanized monoclonal antibody (Campath-1H) that is directed against the 21-28 kD cell surface glycoprotein, CD52. The Campath-1H antibody is an IgG1 kappa with the human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath-1G). Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Alemtuzumab was approved by the FDA in 2001. It is marketed as LEMTRADA for multiple sclerosis (MS) treatment and CAMPTAH for B-cell chronic lymphocytic leukemia (B-CLL). The dose of alemtuzumab used for B-CLL is much higher than that for MS, and also at more frequent dosing.

Indication

用于烷化剂氟达拉滨(fludarabine)治疗失败的B细胞性慢性淋巴细胞白血病患者;亦可用于复发缓解型多发性硬化症治疗。

Associated Conditions

  • B-Cell Chronic Lymphocytic Leukemia
  • Kidney Transplant Rejection
  • Relapsing Remitting Multiple Sclerosis (RRMS)
  • Secondary Progressive Multiple Sclerosis (SPMS)
  • Steroid Refractory Acute Graft Versus Host Disease
  • T-cell Prolymphocytic Leukemia (T-PLL)
  • Refractory Autoimmune Hemolytic Anemia
  • Refractory Idiopathic thrombocytopenic purpura

FDA Approved Products

Campath
Manufacturer:Genzyme Corporation
Route:INTRAVENOUS
Strength:30 mg in 1 mL
Approved: 2023/04/01
NDC:58468-0357
LEMTRADA
Manufacturer:Genzyme Corporation
Route:INTRAVENOUS
Strength:12 mg in 1.2 mL
Approved: 2024/02/21
NDC:58468-0200

Singapore Approved Products

LEMTRADA CONCENTRATE FOR SOLUTION FOR INFUSION 12 MG/ 1.2 ML
Manufacturer:Boehringer Ingelheim Pharma GmbH & Co. KG
Form:INFUSION, SOLUTION CONCENTRATE
Strength:12 mg/1.2 ml
Online:Yes
Approved: 2016/01/08
Approval:SIN14919P

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