TNF-α Inhibitor (PEGylated Fab Fragment) Pregnancy: B (preferred anti-TNF in pregnancy)

Certolizumab Pegol

Brand names: Cimzia

Adult dose

Dose: 400 mg SC at weeks 0, 2, 4 (loading); then 200 mg every 2 weeks or 400 mg every 4 weeks

Route: subcutaneous injection

Frequency: Every 2–4 weeks (maintenance)

Max: 400 mg every 2 weeks

Available as prefilled syringe or autoinjector (CLICK); preferred agent in pregnancy — does not cross placenta at term due to PEGylation without Fc region

Paediatric dose

Route:

Not licensed in children

Dose adjustments

Renal

No dose adjustment required

Hepatic

No dose adjustment required

Clinical pearls

Unique structure: PEGylated Fab fragment with no Fc region — minimal placental transfer at term (CRIB study)
Preferred biologic for RA/SpA in women of childbearing age or during pregnancy
RAPID1/RAPID2 trials: superior to placebo in RA

Contraindications

Active infections
Active or latent TB (screen before starting)
Severe heart failure (NYHA III-IV)

Side effects

Injection site reactions
Upper respiratory tract infection
Headache
Nausea
Rash
Hepatitis reactivation

Interactions

Live vaccines (CI)
Anakinra/abatacept (avoid — serious infections)

Monitoring

FBC
LFTs
Hepatitis B serology before initiation
Signs of infection

Reference: BNFc; BNF 86; NICE TA415; CRIB study. Verify against your local formulary and the latest BNF before prescribing.

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways