Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Certolizumab pegol
Drug ID BADD_D00416
Description Certolizumab pegol is a pegylated monoclonal antibody against the tumor necrosis factor-alpha (TNF-alpha).[A176585] It is formed with a humanized Fab fragment of 50 kDa, from an IgG 1 isotype, fused to a 40 kDa polyethylene glycol moiety replacing the Fc antibody region. The absence of the Fc region was ideated to prevent complement fixation and antibody-mediated cytotoxicity as well as to markedly increase its half-life.[A176606] Certolizumab does not require glycosylation for active function and hence, its production is significantly more affordable when compared to other existing TNF-alpha therapies as it can be done directly in bacterial hosts such as _E. coli_.[A176606] It was developed and manufactured by UCB Pharma, first FDA approved in 2008[L4894] and updated for a new indication on March 28, 2019.[L5819]
Indications and Usage Reducing signs and symptoms of Crohn's disease and treatment of moderately to severely active rheumatoid arthritis (RA).
Marketing Status Prescription
ATC Code L04AB05
DrugBank ID DB08904
KEGG ID D03441
MeSH ID D000068582
PubChem ID Not Available
TTD Drug ID Not Available
NDC Product Code 28877-7300; 49187-0228; 68225-045; 28877-7100; 50474-700; 50474-710
Synonyms Certolizumab Pegol | Cimzia | CDP870 | CDP 870
Chemical Information
Molecular Formula Not Available
CAS Registry Number 428863-50-7
SMILES Not Available
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Nephrotic syndrome20.05.01.002--
Optic neuritis10.04.10.002; 06.04.08.002; 17.04.05.001--Not Available
Pancytopenia01.03.03.003--Not Available
Pericardial effusion02.06.01.002--
Pericarditis02.06.02.001--
Pharyngitis22.07.03.004; 11.01.13.003; 07.05.07.004--
Psoriasis10.02.01.036; 23.03.14.002--Not Available
Pyrexia08.05.02.003--
Rash23.03.13.001--Not Available
Renal failure20.01.03.005--Not Available
Retinal haemorrhage24.07.05.003; 06.10.01.001--Not Available
Sarcoidosis10.02.06.001--Not Available
Stevens-Johnson syndrome11.07.01.005; 10.01.03.020; 23.03.01.007; 12.03.01.014--
Suicide attempt19.12.01.004--
Thrombophlebitis24.01.02.001--Not Available
Toxic epidermal necrolysis23.03.01.008; 12.03.01.015; 11.07.01.006; 10.01.01.006--
Transient ischaemic attack24.04.06.005; 17.08.04.001--
Tuberculosis11.04.01.006--Not Available
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urticaria23.04.02.001; 10.01.06.001--
Uveitis06.04.03.003; 10.02.01.023--
Vasculitis24.05.02.001; 10.02.02.006--
Vasculitis necrotising24.05.02.002; 10.02.02.008--Not Available
Bipolar disorder19.16.01.003--Not Available
Hepatic enzyme increased13.03.01.019--Not Available
Legionella infection11.02.16.001--Not Available
Pneumocystis jirovecii pneumonia22.07.08.009; 11.03.07.005--Not Available
Candida infection11.03.03.021--
Aspergillus infection11.03.01.004--Not Available
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