L04AB05 - Certolizumab Pegol |
Propably not porphyrinogenic |
PNP |
Important Information
Patients on immunosuppressive therapy have an increased risk of infections. Since infections have a potential to trigger acute porphyric attacks vigilance is motivated regarding signs or symptoms of infection and/or possible symptoms of a porphyric attack. Side effects like gastrointestinal discomfort and nausea may potentially be porphyrinogenic through reduction in carbohydrate intake.
Side effects
Infections are common in patients using immunosuppressants and since infections might trigger an acute porphyric attack, vigilance regarding signs and symptoms of an infection and/ or a porphyric attack is recommended. Common adverse reactions of certolizumab pegol that can be confused with an acute porphyric attack are gastrointestinal discomfort and nausea. These side effects may potentially be porphyrinogenic if leading to a decrease in carbohydrate intake.
Rationale
Certolizumab pegol is an antibody preparation not metabolized by CYP enzymes. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Certolizumab pegol is a recombinant, humanised antibody Fab fragment against tumour necrosis factor alpha expressed in Escherichia coli and conjugated to polyethylene glycol (PEG).
Therapeutic characteristics
Certolizumab pegol is a biologic response modifier used in the treatment of moderately to severely active rheumatoid arthritis, progressive psoriatic arthritis and Crohns disease. It is administered subcutaneously.
Metabolism and pharmakokinetics
The Fab protein component is degraded to peptides and amino acids by proteolysis. Certolizumab pegol is not metabolized by hepatic cytochrome P-450 (CYP) enzymes.
The elimination half-life og certolizumab pegol is about 14 days.
References
- Scientific articles
- Keizer, R.J., Huitema, A.D.R., Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies. Clin Pharmacokinet. 2010 Aug 1;49(8):493-507 PMID 20608753. #4607
- Lee, J.I., Zhang, L., CYP-Mediated Therapeutic Protein-Drug Interactions, clinical findings, proposed mechanisms and regulatory implications. Clin Pharmacokinet. 2010 May 1;49(5):295-310 PMID 20384392. #4608
- Mease, P.J., Certolizumab pegol in the treatment of rheumatoid arthritis: a comprehensive review of its clinical efficacy and safety. Rheumatology (Oxford). 2010 Sep 25. #2300
- Wallis, R. S., Infectious complications of tumor necrosis factor blockade. Curr Opin Infect Dis. 2009 Aug;22(4):403-9. PMID 19491672. #2305
- Mittal M, Raychaudhuri SP. Golimumab and certolizumab: The two new anti-tumor necrosis factor kids on the block. Indian J Dermatol Venereol Leprol 2010;76:602-9 PMID 21079302. #2301
- Drug reference publications
- Sweetman SC, editor. Martindale: The complete drug reference. Gcertolizumab pegol. Pharmaceutical Press 2009. #2303
- Summary of Product Characteristics
- Norwegian medicines agency. Summary of Product Characteristics (SPC). Cimzia. #2302
- The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Cimzia. (Last edition: october 2014). #2304
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