Anti-TNF Monoclonal Antibody Pregnancy: Should only be used during pregnancy if clearly needed. Women of childbearing potential should consider adequate contraception and continue it for at least five months after the last dose. Adalimumab may cross the placenta into the serum of infants, who may be at increased risk of infection - live vaccines (e.g. BCG) are not recommended in exposed infants for 5 months following the mother's last dose in pregnancy. Excreted in breast milk at very low concentrations (0.1% to 1% of maternal serum level); no effects on breast-fed infants are anticipated.

Adalimumab (IBD)

Brand names: Humira, Amgevita (biosimilar), Hyrimoz (biosimilar)

Adalimumab is a recombinant human anti-TNF monoclonal antibody given by subcutaneous injection; in this context it is used to induce and maintain remission in inflammatory bowel disease (Crohn's disease and ulcerative colitis).

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: Crohn's disease (adults): induction 80 mg at week 0 followed by 40 mg at week 2; where a more rapid response is needed, 160 mg at week 0 (given as two 80 mg injections in one day, or as one 80 mg injection per day for two consecutive days) followed by 80 mg at week 2, with the awareness that the risk of adverse events is higher during induction. After induction, 40 mg every other week. Ulcerative colitis (adults): induction 160 mg at week 0 (given as two 80 mg injections in one day, or as one 80 mg injection per day for two consecutive days) and 80 mg at week 2; after induction the SPC text states 'the recommended dose is 40 mg ...' but is truncated in the fetched bundle - see notes.

Route: Subcutaneous injection

Frequency: Maintenance: every other week (following the induction schedule above)

SOURCE TRUNCATION: the eMC section 4.2 ulcerative colitis paragraph is cut off in the fetched bundle at 'After induction treatment, the recommended dose is 40 mg ...'. The US label (IDACIO) in the same bundle states, for adult ulcerative colitis, 40 mg every other week starting on Day 29, and to discontinue in adults without evidence of clinical remission by eight weeks (Day 57). Clinician to confirm the UC maintenance dose and stopping rule against the full SPC. Dose escalation: some patients who experience a decrease in response to 40 mg every other week may benefit from an increase to 40 mg every week or 80 mg every other week; some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12, and continued therapy should be carefully reconsidered if there is no response within that period. Treatment should be initiated and supervised by specialist physicians; other concomitant therapies (e.g. corticosteroids and/or immunomodulators) should be optimised, and corticosteroids may be tapered during maintenance. Dose interruption may be needed (e.g. before surgery or with serious infection); re-introduction after 70 days or longer gave the same magnitude of response and similar safety. Re-administration after stopping is possible, but there is little experience of re-administration more than 8 weeks after the previous dose. PAEDIATRIC IBD: dosing is weight-band based and is not reproduced here - verify against a children's formulary and the full SPC.

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, and opportunistic infections
Moderate to severe heart failure (NYHA class III/IV)

Side effects

Infections, including nasopharyngitis, upper and lower respiratory tract infection, pneumonia and sinusitis (very common)
Injection site reactions - erythema, itching, haemorrhage, pain or swelling (very common)
Headache (very common)
Musculoskeletal pain (very common)
Serious infections including sepsis, opportunistic infections and tuberculosis (reactivation and new onset), and hepatitis B virus reactivation
Malignancies (including leukaemia, lymphoma and hepatosplenic T-cell lymphoma); serious haematological (pancytopenia, aplastic anaemia), neurological (demyelinating events) and autoimmune reactions (lupus and lupus-related conditions, Stevens-Johnson syndrome)

Interactions

Abatacept - increased risk of serious infection; concomitant use not recommended (US label section 7.2; eMC section 4.5 not captured in the fetched bundle)
Anakinra - increased risk of serious infection; concomitant use not recommended (US label section 7.2)
Other biologic DMARDs / other TNF blockers - concomitant use not recommended (US label section 7.2)
Live vaccines - avoid during treatment (US label section 7.3)
Methotrexate - reduces apparent adalimumab clearance but no dose adjustment of either drug is indicated (US label section 7.1)

Clinical monograph

How it works

It binds tumour necrosis factor-alpha and neutralises its pro-inflammatory activity, reducing the mucosal inflammatory cascade that drives inflammatory bowel disease.

Prescribing in practice

Screen for and treat latent tuberculosis and other serious infections (including hepatitis B) before starting, as anti-TNF therapy can reactivate them and increases overall infection risk.
Avoid live vaccines during treatment and assess for heart failure and demyelinating disease, which may be worsened by TNF blockade.
There is a recognised risk of malignancy including a rare hepatosplenic T-cell lymphoma when combined with thiopurines, so weigh combination immunosuppression carefully.

Monitoring

Monitor clinically and biochemically for infection, and review disease activity, inflammatory markers and treatment response in line with the specialist gastroenterology pathway.

Counselling the patient

Report fever, persistent cough, night sweats or any sign of infection promptly.
Self-injection technique and safe sharps disposal should be confirmed, and injections rotated between sites.
Tell any healthcare professional you are on a biologic before vaccinations or surgery.

Evidence & guidelines

NICE technology appraisals support adalimumab for moderate-to-severe Crohn's disease and ulcerative colitis, and MHRA advice highlights tuberculosis and serious-infection risks with anti-TNF agents.

Reference: NICE TA187 (Crohn's); NICE TA329 (UC); ECCO IBD Guidelines 2021; BSG Biologic Monitoring Guidelines; 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

Drugs

Infliximab · Anti-TNF Monoclonal Antibody

Pathways