Information about Certolizumab
Certolizumab is a Fab fragment of a monoclonal antibody to human tumor necrosis factor alpha (TNFα) which has potent antiinflammatory activity and is used in the therapy of severe rheumatoid arthritis and inflammatory bowel disease.
Mechanism of action of Certolizumab
Recombinant monoclonal antibody to TNFα linked to polyethylene glycol. The monoclonal antibody fragment binds avidly to serum and tissue bound TNFα causing its inactivation and degradation. Inhibition of TNFα activity leads to modulation of the inflammatory and pain pathways activated by this cytokine. The polyethylene glycol alters its pharmacokinetics, prolonging its half-life, and allowing for every 4 week administration.
FDA approval information for Certolizumab
Certolizumab was approved in the United States in 2007 for use in Crohn disease and its indications were subsequently extended to rheumatoid and psoriatic arthritis and ankylosing spondylitis.
Clinical use of Certolizumab
Certolizumab is considered a disease modifying antirheumatic drug (DMARD) and has been shown to improve symptoms as well as joint and cartilage damage in the inflammatory arthritides.
Dosage and administration for Certolizumab
Certolizumab is available as lyophilized powder for reconstitution or in prefilled syringes as 200 mg/1.0 mL under the brand name of Cimzia. The typical dose of certolizumab for Crohn disease is 200 to 400 mg subcutaneously initially and at weeks 2 and 4, followed by 400 mg every 4 weeks. Recommendations vary slightly by indication.
Side effects of Certolizumab
- Common side effects include injection site reactions, headache, nausea, abdominal discomfort, diarrhea, skin rash and fever.
- Severe side effects include bone marrow suppression and hypersensitivity reactions.
- TNFα antagonists are also capable of causing immune suppression, which can result in reactivation of microbial infections including tuberculosis and hepatitis B.
Brand name for Certolizumab
Certolizumab – Cimzia®
Drug class for Certolizumab