Certolizumab pegol 200mg/1ml solution for injection pre-filled disposable devices
Requires a prescription from a doctor or prescriber
Drugs used in rheumatic diseases and gout
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
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1 branded products available
MHRA licensed products
View all licensed products for Certolizumab pegol on the MHRA register
Cimzia 200mg/1ml solution for injection pre-filled pens
WHO defined daily dose (DDD)
14 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Certolizumab pegol
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(15)
Certolizumab pegol for treating moderate to severe plaque psoriasis (TA574)
Certolizumab pegol for treating rheumatoid arthritis after inadequate response to a TNF-alpha inhibitor (TA415)
Certolizumab pegol and secukinumab for treating active psoriatic arthritis after inadequate response to DMARDs (TA445)
Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (TA375)
Golimumab for treating active non-radiographic axial spondyloarthritis (TA497)
TNF-alpha inhibitors for treating active ankylosing spondylitis and non-radiographic axial spondyloarthritis (TA383)
Upadacitinib for treating severe rheumatoid arthritis (TA665)
Sarilumab for moderate to severe rheumatoid arthritis (TA485)
Spondyloarthritis in over 16s: diagnosis and management (NG65)
Ixekizumab for treating active psoriatic arthritis after inadequate response to DMARDs (TA537)
Tofacitinib for moderate to severe rheumatoid arthritis (TA480)
Tofacitinib for treating active psoriatic arthritis after inadequate response to DMARDs (TA543)
Filgotinib for treating moderate to severe rheumatoid arthritis (TA676)
Tocilizumab for the treatment of rheumatoid arthritis (TA247)
Adalimumab, etanercept, infliximab and abatacept for treating moderate rheumatoid arthritis after conventional DMARDs have failed (TA715)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
14 days
Mechanism
Certolizumab targets the activation of TNF-alpha with high affinity (KD 90 pM and IC90 0.
Food interactions
None known
Human targets
1 target
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
171 hours
[A176606]…
Half-life
14 days
[A176606]
Protein binding
Volume of distribution
4-8 L
[A176666]…
Metabolism
Elimination
Clearance
9-14 ml
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
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[L45018] and updated for a new indication on March 28, 2019.[L5819]
- Symptomatic management of Chron's disease patients and for the maintenance of clinical response in patients with moderate to severe disease with inadequate response to conventional therapy.
- Treatment of adult patients with moderate to severely active rheumatoid arthritis.
- Treatment of adult patients with active psoriatic arthritis.
- Treatment of adult patients with active ankylosing spondylitis.
- Treatment of adult patients with moderate-to-severe plaque psoriasis that are candidates for systemic therapy or phototherapy.[FDA label]
- Treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation.
[L5819]
In Canada, certolizumab pegol is additionally approved in combination with [methotrexate] for the symptomatic treatment, including major clinical response, and for the reduction of joint damage in adult patients with moderately to severely active rheumatoid arthritis and psoriatic arthritis.
[L5825]
Inflammation is a biological response against a potential threat. This response can be normal but in certain conditions, the immune system can attack the body's normal cells or tissues which causes an abnormal inflammation.
[L5840]
TNF-alpha has been identified as a key regulator of the inflammatory response. The signaling cascades of this inflammatory mediator can produce a wide range of reactions including cell death, survival, differentiation, proliferation and migration.
[A176660]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 1890 interactions
Certolizumab pegol does not present mutagenic potential nor presents effects in fertility and reproductive performance. On the other hand, carcinogenicity studies have not been performed.[FDA label]
One additional feature od certolizumab pegol is that, due to the presence of the PEGylation, it is more significantly distributed into inflamed tissues when compared to other TNF-alpha inhibitors such as [infliximab] and [adalimumab].[A176606]
In vitro studies with certolizumab pegol in human tissue did not show any unexpected binding at 3 mcg/ml nor at 10 mcg/ml. Due to the drug class, certolizumab pegol is not expected to present adverse effects on the major vital systems.F4232
In phase III clinical trials in psoriatic arthritis patients, certolizumab pegol was reported to generate improvements in skin disease, joint involvement, dactylitis, enthesitis and general life quality. The clinical effect of certolizumab was paired to a comparable safety profile to other TNF-alpha inhibitors.[A176606]
The clinical effectiveness of certolizumab pegol was mainly studied in six randomized controlled trials that compared its effect versus placebo. In a comparative study, the efficacy for certolizumab pegol registered ranged from 30-65% while in placebo ranged from 4-25%.[A176612] However, in other additional trials, certolizumab was proven to present a similar clinical efficacy to other disease-modifying antirheumatic drugs in patients with inadequate response to TNF inhibitors.[A176603]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[A176606]
Certolizumab presents a linear pharmacokinetic profile with a peak plasma concentration of 43-49 mcg/ml.F4232
[A176606]
[A176666]
It is known to have a very good distribution in the joints when compared to other TNF-alpha inhibitors.
[A176645]
[A31470]
On the other hand, the PEG section is processed normally by the action of the alcohol dehydrogenase to the formation of carboxylic acid.
[A176672]
[A176606]
Proteins and enzymes this drug interacts with in the body
Impairs regulatory T-cells (Treg) function in individuals with rheumatoid arthritis via FOXP3 dephosphorylation. Up-regulates the expression of protein phosphatase 1 (PP1), which dephosphorylates the key 'Ser-418' residue of FOXP3, thereby inactivating FOXP3 and rendering Treg cells functionally defective .
PMID:23396208
Key mediator of cell death in the anticancer action of BCG-stimulated neutrophils in combination with DIABLO/SMAC mimetic in the RT4v6 bladder cancer cell line .
PMID:16829952 PMID:22517918 PMID:23396208
Induces insulin resistance in adipocytes via inhibition of insulin-induced IRS1 tyrosine phosphorylation and insulin-induced glucose uptake. Induces GKAP42 protein degradation in adipocytes which is partially responsible for TNF-induced insulin resistance (By similarity).
Plays a role in angiogenesis by inducing VEGF production synergistically with IL1B and IL6 .
PMID:12794819
Promotes osteoclastogenesis and therefore mediates bone resorption (By similarity)
Enzymes involved in drug metabolism — important for understanding drug interactions
ATC L04AB05
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Certolizumab pegol
Additional database identifiers
Drugs Product Database (DPD)
20513
HUGO Gene Nomenclature Committee (HGNC)
HGNC:11892
GenAtlas
TNF
GeneCards
TNF
GenBank Gene Database
M16441
GenBank Protein Database
339741
UniProt Accession
TNFA_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:380
GeneCards
AKR1A1
GenBank Gene Database
J04794
GenBank Protein Database
178481
UniProt Accession
AK1A1_HUMAN
Patent information
All patents expired, 1 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
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