Ofatumumab
- Atc Codes:L01XC10
- CAS Codes:679818-59-8
- PHARMGKB ID:679818-59-8
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Arzerra; Bulgaria: Arzerra; Czech Republic: Arzerra; Denmark: Arzerra; Estonia: Arzerra; Finland: Arzerra; France: Arzerra; Germany: Arzerra; Greece: Arzerra; Hungary: Arzerra; Ireland: Arzerra; Latvia: Arzerra; Lithuania: Arzerra; Luxembourg: Arzerra; Malta: Arzerra; Netherlands: Arzerra; Poland: Arzerra; Portugal: Arzerra; Romania: Arzerra; Slovakia: Arzerra; Slovenia: Arzerra; Spain: Arzerra; Sweden: Arzerra; UK: Arzerra.
North America
USA: Arzerra.
Asia
Japan: Arzerra.
Drug combinations
Chemistry
Ofatumumab: C~6480~H~10022~N~1742~O~2020~S~44~. Mw: 149. Immunoglobulin G~1~, anti-(human CD20 (antigen))(human monoclonal HuMax-CD20 heavy chain), disulfide with human monoclonal HuMax-CD20 κ-chain, dimer. CAS-679818-59-8.
Pharmacologic Category
Antineoplastic Agents, Monoclonal Antibody. (ATC-Code: L01XC10).
Mechanism of action
Ofatumumab is a monoclonal antibody which binds specifically the extracellular (large and small) loops of the CD20 molecule (which is expressed on normal B lymphocytes and in B-cell CLL) resulting in potent complement-dependent cell lysis and antibody-dependent cell-mediated toxicity in cells that overexpress CD20.
Therapeutic use
Treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab. The effectiveness of ofatumumab is based on the demonstration of durable objective responses. No data demonstrate an improvement in disease-related symptoms or increased survival.
Pregnancy and lactiation implications
Based on animal data, may cause fetal harm (use in pregnancy only if potential benefit to mother outweighs potential risk to fetus). Caution should be used in nursing women receiving ofatumumab (published data suggest that consumption of breast milk does not result in substantial absorption of maternal antibodies into circulation).
Unlabeled use
Contraindications
There are no contraindications listed within the manufacturer’s labeling.
Warnings and precautions
Infusion reactions may occur (premedicate with an intravenous corticosteroid, an oral analgesic, and an oral or intravenous antihistamine; monitor patients closely during infusions; interrupt infusion if infusion reactions occur). Cytopenias have been observed (monitor blood counts at regular intervals for neutropenia and thrombocytopenia). Progressive multifocal leukoencephalopathy (PML)(monitor neurologic function and discontinue treatment if PML is suspected). May induce hepatitis B reactivation (discontinue treatment in patients who develop viral hepatitis or reactivation of viral hepatitis). Small intestine obstruction may occur with this treatment. Live vaccines should not be given concurrently with ofatumumab.