Acute Porphyria Drug Database

Monograph

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 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.

References

# Citation details PMID
*Scientific articles
1. Keizer, R.J., Huitema, A.D.R., Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies.
Clin Pharmacokinet. 2010 Aug 1;49(8):493-507
20608753
2. 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
20384392
3. 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.
4. Wallis, R. S., Infectious complications of tumor necrosis factor blockade.
Curr Opin Infect Dis. 2009 Aug;22(4):403-9.
19491672
5. Golimumab and certolizumab: The two new anti-tumor necrosis factor kids on the block. Indian J Dermatol Venereol Leprol 2010;76:602-9
Mittal M, Raychaudhuri SP.
21079302
*Drug reference publications
6. Sweetman SC, editor. Martindale: The complete drug reference. Gcertolizumab pegol. Pharmaceutical Press 2009.
*Summary of Product Characteristics
7. Norwegian medicines agency. Summary of Product Characteristics (SPC). Cimzia.
8. The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). Cimzia. (Last edition: october 2014).

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Tradenames and packages
From some sources, we get a list of packages (United Kingdom, Ireland, Estonia). Other sources contain more or less "clean" versions of the trade name (Denmark, Finland, Iceland, Lithuania, Norway). What you see here is the raw data we get from each country, so there will appear to be duplicates. The bold names are the searchable terms. The gray names that follow are all mapped to the bolded term.
Note: The cleaning is done automatically by a proprietary algorithm, and it may produce errors. We strive to improve it continuously.
Netherlands
Cimzia · Cimzia 200 mg
Belgium
Cimzia · Cimzia 200 mg sol. inj. s.c. cart. · Cimzia 200 mg sol. inj. s.c. ser. préremplie · Cimzia 200 mg sol. inj. s.c. stylo prérempli
United Kingdom
Cimzia · Cimzia 200mg/1ml solution for injection in a dose-dispenser cartridge · Cimzia 200mg/1ml solution for injection pre-filled pens · Cimzia 200mg/1ml solution for injection pre-filled syringes
Denmark
Cimzia
Norway
Cimzia
Poland
Cimzia
Luxembourg
CIMZIA · CIMZIA-200
Iceland
Cimzia
Finland
Cimzia
Latvia
Cimzia
 
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