TNF-α Inhibitor (PEGylated Fab Fragment) Pregnancy: Large body of data (>1500 first-trimester exposures) indicates no malformative nor feto/neonatal toxicity. Placental transfer is negligible/low. Consider adequate contraception in women of childbearing potential; if clearing drug before conception, continue contraception for 5 months after the last dose. Wait a minimum of 5 months after the mother's last dose in pregnancy before giving live/live-attenuated vaccines to the infant.

Certolizumab Pegol

Brand names: Cimzia

Certolizumab pegol is a PEGylated anti-tumour necrosis factor (TNF) monoclonal antibody fragment used in rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis and Crohn's disease.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 400 mg loading (2 x 200 mg SC) at weeks 0, 2 and 4, then 200 mg every 2 weeks (maintenance)

Route: subcutaneous injection

Frequency: loading at weeks 0, 2, 4; then every 2 weeks

Treatment initiated and supervised by specialist physicians. Loading dose (rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis): 400 mg (2 SC injections of 200 mg) at weeks 0, 2 and 4. Maintenance: rheumatoid arthritis 200 mg every 2 weeks (alternative 400 mg every 4 weeks once response confirmed); axial spondyloarthritis 200 mg every 2 weeks or 400 mg every 4 weeks (after >=1 year sustained remission, 200 mg every 4 weeks may be considered); psoriatic arthritis 200 mg every 2 weeks (alternative 400 mg every 4 weeks); plaque psoriasis 200 mg every 2 weeks (400 mg every 2 weeks if insufficient response). For RA and PsA, MTX should be continued where appropriate. PAEDIATRIC (UK SPC): safety and efficacy not established; should not be used in children/adolescents below 18 years. Injected into thigh or abdomen. No dose recommendations for renal or hepatic impairment (not studied).

Dose adjustments

Renal

Not studied in renal impairment; no dose recommendations can be made.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substance or to any of the excipients
Active tuberculosis or other severe infections such as sepsis or opportunistic infections
Moderate to severe heart failure (NYHA class III/IV)

Side effects

Upper respiratory tract infections
Rash
Urinary tract infections
Serious infections (including sepsis, tuberculosis, opportunistic infections)
Administration site (injection site) reactions

Interactions

Anakinra, abatacept — combination not recommended (increased risk of serious infections with TNF blockers)
Rituximab, natalizumab — combination not recommended
Live (including attenuated) vaccines — avoid during or immediately prior to therapy
May cause erroneously elevated aPTT (activated partial thromboplastin time) assay results

Clinical monograph

How it works

It binds and neutralises tumour necrosis factor alpha, blocking its pro-inflammatory signalling; unlike whole antibodies it lacks an Fc region.

Prescribing in practice

It increases the risk of serious infection, including reactivation of tuberculosis and hepatitis B; screen for latent infection before starting and avoid in active infection.
Live vaccines should be avoided during treatment; its minimal placental transfer relative to other anti-TNF agents may make it preferable in pregnancy when an anti-TNF is needed.
Avoid in moderate to severe heart failure as anti-TNF therapy can worsen it.

Monitoring

Monitor for signs of infection, with periodic full blood count, and remain alert to demyelinating or new autoimmune symptoms.

Counselling the patient

Report fevers, persistent cough, night sweats or other signs of infection promptly.
Avoid live vaccines and tell vaccinating clinicians you are on this treatment.
Discuss with your team if you are planning pregnancy or breastfeeding.

Evidence & guidelines

NICE recommends anti-TNF agents including certolizumab pegol for specific inflammatory rheumatological and bowel conditions, supported by randomised trial evidence.

Reference: NICE TA415; CRIB study; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways