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Ofatumumab

Ofatumumab
Monoclonal antibody
Type Whole antibody
Source Human
Target CD20
Clinical data
Trade names Arzerra
AHFS/Drugs.com Monograph
MedlinePlus a610009
License data
Pregnancy
category
  • US: C (Risk not ruled out)
Routes of
administration
IV
ATC code
Legal status
Legal status
Pharmacokinetic data
Biological half-life 14 days
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
ChEMBL
Chemical and physical data
Formula C6480H10022N1742O2020S44
Molar mass 146.1 kg/mol
 NYesY (what is this?)  

Ofatumumab (trade name Arzerra, also known as HuMax-CD20) is a fully human monoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia. This makes ofatumumab the first marketing application for an antibody produced by Genmab, as well as the first human monoclonal antibody which targets the CD20 molecule that will be available for patients with refractory CLL.

Its only indication that has received regulatory approval is Chronic lymphocytic leukaemia (CLL).

It first received FDA approval on April 17, 2014, for use in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate MHRA approval on the 19th of April 2010,

EMA approval on the 14th of June 2010 and Health Canada approval on the 13th of August 2012.

Adverse effects by frequency:
Very common (>10% frequency):

Common (1-10% frequency):'

Uncommon (0.1-1% frequency):

Rare (<0.1% frequency):

Ofatumumab has received a black box warning regarding the potential for it to cause progressive multifocal leukoencephalopathy and Hepatitis B reactivation. Likewise it is also advised that doctors watch cautiously for small bowel obstruction, neutropenia, thrombocytopenia, infusion reactions or an increased risk for infection.


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