Ofatumumab

  • CAS Number: 679818-59-8

Ofatumumab ( Arzerra, HuMax -CD20 ) is a human monoclonal antibody (IgG1 ), which is used in the treatment of certain types of leukemia.

Operation

Ofatumumab, the protein binds specifically to CD20 on B-lymphocytes, specifically to a specific epitope that comprises both extracellular loops, the small and large of the CD20 molecule. Here cytotoxicity is initiated, which leads to lysis of the cells. Ofatumumab is also effective in cells that are resistant to rituximab.

Application

Ofatumumab is used in patients with chronic lymphocytic leukemia who are refractory to fludarabine and alemtuzumab. The authorization is based on the intermediate results of a single-arm, multicenter phase III trial, was subject to the condition that further clinical data are submitted. The monotherapy with ofatumumab resulted in the pivotal study on double- refractory patients to a response rate of 58%. Ofatumumab is being investigated for use in other cancers, such as follicular non-Hodgkin's lymphoma and diffuse large B- cell lymphoma.

Dosage

The normal dose regimen includes 8 consecutive infusions at weekly intervals with 300 mg of ofatumumab in the first and 2000 mg in the following infusions. Finally, another 4 more infusions at monthly intervals. In addition, a prednisone equivalent, as well as an analgesic and an antihistamine be administered.

Side effects

In the pivotal study (Hx -CD20 -406 ) came alongside infusion reactions such as fever, chills, and cardiac events, often bacterial, viral and fungal infections. Common side effects are also neutropenia, thrombocytopenia, leukopenia, tachycardia, nausea, pain in the nasopharyngeal space and back.

After the occurrence of fulminant hepatitis during therapy with ofatumumab a Red Hand letter was published on 16 December 2013. Before starting any treatment a hepatitis B virus (HBV ) screening is recommended. Patients with active hepatitis B should not be treated with the antibody. In the case of a positive hepatitis B serology potential application must be monitored and, if necessary accompanied by antiviral therapy.

Swell

  • ABDA database through WINAPO Lauer Taxe: datasheet Arzerra, Booth May 15, 2011
  • Pharmaceutical newspaper, Booth May 17, 2011
CAS registry number Anatomical Therapeutic Chemical Classification System B cell
611712
de