Certolizumab pegol
Also known as: CDP870, certolizumab, Certolizumab pegol, Cimzia, RN777
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Summary
Certolizumab pegol is a pegylated Fab' fragment of a humanized monoclonal antibody that selectively inhibits tumor necrosis factor‑α. It is administered subcutaneously for several autoimmune inflammatory diseases.
Mechanism of Action
Binds soluble and transmembrane TNF‑α, neutralizing its activity and preventing downstream inflammatory signaling.
Routes of Administration
Goals & Uses
- Ankylosing spondylitisAutoimmune DiseaseHigh
- Rheumatoid arthritis disease activity reductionRheumatologyHigh
- Ulcerative colitisGastrointestinalModerate
- Psoriatic arthritisAutoimmune DiseaseHigh
- Rheumatoid arthritisAutoimmune DiseaseHigh
- Ankylosing spondylitis and non-radiographic axial spondyloarthritis treatmentRheumatologyHigh
- Moderate-to-severe plaque psoriasisDermatologyHigh
- Crohn's disease remission induction and maintenanceGastroenterologyHigh
- Psoriatic arthritis symptom controlRheumatologyHigh
- Pregnancy-compatible anti-TNF therapyObstetrics/RheumatologyModerate
- Crohn's diseaseGastrointestinalHigh
Contraindications
- Hypersensitivity to certolizumab pegol or excipientsAllergy/ImmunologyHigh
- Moderate-to-severe heart failure (NYHA class III/IV)CardiovascularHigh
- Active tuberculosis or other severe infectionsInfectious DiseaseHigh
- Severe active infectionsInfectionHigh
- Hypersensitivity to certolizumab pegol or PEGAllergyHigh
- Demyelinating disordersNeurologyModerate
- Active tuberculosisInfectiousHigh
- Active hepatitis B infectionInfectious DiseaseHigh
Adverse Effects
- Pregnancy complicationsReproductiveUnknown
- Injection site reactionsLocalCommon
- Hypersensitivity/anaphylaxisImmunologicalRare
- Malignancies (lymphoma, solid tumors)OncologicRare
- Upper respiratory tract infectionsInfectious DiseaseCommon
- Autoimmune reactions (drug-induced lupus, autoantibody formation)ImmunologicUncommon
- Headache and nasopharyngitisGeneral/RespiratoryCommon
- Serious infections (e.g., pneumonia, sepsis)InfectiousUncommon
- Malignancies (e.g., lymphoma, skin cancer)OncologicRare
- Serious infections (bacterial, fungal, viral, opportunistic)InfectiousUncommon
Drug Interactions
- Other biologic DMARDs (e.g., rituximab, tocilizumab)Moderate
- AnakinraHigh
- Live vaccinesHigh
- CorticosteroidsModerate
- Other immunosuppressants (e.g., methotrexate, azathioprine)Moderate
- AbataceptHigh
- MethotrexateLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patients (<18 years)AgeRelative
- Pediatric patients (<18 y)AgeRelative
- Immunocompromised patientsImmunologicRelative
- Elderly patientsAgeRelative
- Patients with latent tuberculosisInfectious DiseaseRelative
- BreastfeedingReproductiveRelative
Regulatory Status
- European UnionApprovedApproved: Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Crohn's disease, Ulcerative colitisEMA approval 2009.
- United StatesApprovedApproved: Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Crohn's disease, Ulcerative colitisFDA approval 2010; marketed as Cimzia.
- United KingdomApprovedApproved: Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis, Crohn's disease, Ulcerative colitisMHRA approval aligned with EU.
Approved in the US (2010), EU (2009), and UK for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease and ulcerative colitis. Marketed under the brand name Cimzia.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Certolizumab pegol?
Certolizumab pegol is a pegylated Fab' fragment of a humanized monoclonal antibody that selectively inhibits tumor necrosis factor‑α. It is administered subcutaneously for several autoimmune inflammatory diseases.
What is Certolizumab pegol used for?
Certolizumab pegol is educationally associated with: Ankylosing spondylitis, Rheumatoid arthritis disease activity reduction, Ulcerative colitis, Psoriatic arthritis, Rheumatoid arthritis, Ankylosing spondylitis and non-radiographic axial spondyloarthritis treatment, Moderate-to-severe plaque psoriasis, Crohn's disease remission induction and maintenance, Psoriatic arthritis symptom control, Pregnancy-compatible anti-TNF therapy, Crohn's disease. Educational only — not medical advice.
How is Certolizumab pegol administered?
Recorded routes of administration: Intravenous, Subcutaneous.
What are the potential side effects of Certolizumab pegol?
Reported adverse effects include: Pregnancy complications, Injection site reactions, Hypersensitivity/anaphylaxis, Malignancies (lymphoma, solid tumors), Upper respiratory tract infections, Autoimmune reactions (drug-induced lupus, autoantibody formation), Headache and nasopharyngitis, Serious infections (e.g., pneumonia, sepsis), Malignancies (e.g., lymphoma, skin cancer), Serious infections (bacterial, fungal, viral, opportunistic). This list is not exhaustive — consult a qualified clinician.
Who should avoid Certolizumab pegol?
Recorded contraindications: Hypersensitivity to certolizumab pegol or excipients, Moderate-to-severe heart failure (NYHA class III/IV), Active tuberculosis or other severe infections, Severe active infections, Hypersensitivity to certolizumab pegol or PEG, Demyelinating disorders, Active tuberculosis, Active hepatitis B infection. Consult a qualified clinician before use.