Certolizumab Pegol
- Atc Codes:L04AB05
- CAS Codes:428863-50-7
- PHARMGKB ID:428863-50-7
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
- Nutrition/Nutraceutical Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Cimzia; Belgium: Cimzia; Bulgaria: Cimzia; Czech Republic: Certolizumab pegol, Cimzia; Denmark: Cimzia; Estonia: Cimzia; Finland: Cimzia; France: Cimzia; Germany: Cimzia; Greece: Cimzia; Hungary: Cimzia; Ireland: Cimzia; Latvia: Cimzia; Lithuania: Cimzia; Luxembourg: Cimzia; Malta: Cimzia; Netherlands: Cimzia; Poland: Cimzia; Portugal: Cimzia; Romania: Cimzia; Slovakia: Cimzia; Slovenia: Cimzia; Spain: Cimzia; Sweden: Cimzia; UK: Cimzia.
North America
Canada: Cimzia; USA: Cimzia.
Drug combinations
Chemistry
Certolizumab Pegol: C~2115~H~3252~N~556~O~673~S~16~ (peptide). Mw: 91 kDa. Immunoglobulin, anti-(human tumor necrosis factor α) Fab’ fragment (human-mouse monoclonal CDP870 heavy chain), disulfide with human-mouse monoclonal CDP870 light chain, pegylated at Cys-221. The Fab’ fragment is composed of a light chain with 214 amino acids and a heavy chain with 229 aa. CAS: 428863-50-7.
Pharmacologic Category
Miscellaneous Therapeutic Agents; Biologic Response Modifiers, Disease-modifying Antirheumatic Drugs. Immunomodulator, TNF blocker. (ATC-Code: L04AB05).
Mechanism of action
Certolizumab pegol binds to TNFα, inhibiting its role as a key mediator of inflammation. Elevated levels of TNFα have been implicated in the pathology of Crohn’s disease and rheumatoid arthritis. TNFα is strongly expressed in the bowel wall in areas involved by Crohn’s disease and fecal concentrations of TNFα in patients with Crohn’s disease have been shown to reflect clinical severity of the disease. After treatment with certolizumab pegol, patients with Crohn’s disease demonstrated a decrease in the levels of C-reactive protein (CRP). Increased TNFα levels are found in the synovial fluid of rheumatoid arthritis patients and play an important role in the joint destruction that is a hallmark of this disease. Does not contain a fragment crystallizable (Fc) region, which is normally present in a complete antibody, and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro. Certolizumab pegol showed no reactivity with a designated standard panel of normal human tissues.
Therapeutic use
Indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. Treatment of adults with moderately to severely active rheumatoid arthritis.
Pregnancy and lactiation implications
Should be used during pregnancy only if clearly needed. Not recommended during lactation.
Unlabeled use
Contraindications
None known to date.
Warnings and precautions
Increased risk of serious infections; if an infection becomes serious, treatment should be stopped. Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers. Hepatitis B virus (HBV) reactivation may occur in HBV carriers during and several months after therapy; if reactivation occurs, treatment should be stopped. If symptoms of cytopenias or pancytopenia develop, stopping the drug should be considered. Treatment should also be stopped if Lupus-like syndrome develops. Heart failure, worsening or new onset, anaphylaxis or serious allergic reactions and demyelinating disease, exacerbation or new onset, may occur.