L04AB05 - Certolizumab Pegol |
Probably 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 pharmacokinetics
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.
Similar drugs
References
| # | Citation details | PubMed ID |
|---|---|---|
| 1. | Clinical pharmacokinetics of therapeutic monoclonal antibodies.
Keizer RJ, Huitema AD, et al. Clin Pharmacokinet. 2010 Aug; 49(8):493-507.
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20608753 |
| 2. | CYP-mediated therapeutic protein-drug interactions: clinical findings, proposed mechanisms and regulatory implications.
Lee JI, Zhang L, et al. Clin Pharmacokinet. 2010 May; 49(5):295-310.
|
20384392 |
| 3. | Certolizumab pegol in the treatment of rheumatoid arthritis: a comprehensive review of its clinical efficacy and safety.
Mease PJ. Rheumatology (Oxford). 2011 Feb; 50(2):261-70.
|
20871129 |
| 4. | Golimumab and certolizumab: the two new anti-tumor necrosis factor kids on the block.
Mittal M, Raychaudhuri SP. Indian J Dermatol Venereol Leprol. 2010; 76(6):602-8; quiz 609.
|
21079302 |
| 5. | Infectious complications of tumor necrosis factor blockade.
Wallis RS. Curr Opin Infect Dis. 2009 Aug; 22(4):403-9.
|
19491672 |
| Drug reference publications | ||
| 6. | Sweetman SC, editor. Martindale: The complete drug reference. Gcertolizumab pegol. Pharmaceutical Press 2009.
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| Summary of Product Characteristics | ||
| 7. | Norwegian medicines agency. Summary of Product Characteristics (SPC). Cimzia.
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| 8. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Cimzia. (Last edition: october 2014).
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Tradenames