BLACK BOX WARNING
- serious infections including TB reactivation and invasive fungal infections; malignancy (lymphoma and other cancers, especially in children/adolescents/young adults) — discontinue if serious infection or lymphoma develops
adalimumab (GI indication)
Brand: Humira
⚠ BBW Prototype: infliximab
Drug Class: TNF-alpha inhibitor
Drug Family: biologic DMARD
Subclass: fully human anti-TNF monoclonal antibody
Organ Systems: gastrointestinalimmunology
Mechanism of Action
Fully human monoclonal IgG1 antibody that binds both soluble and membrane-bound TNF-alpha, neutralizing its pro-inflammatory signaling, reducing cytokine-driven inflammation in the intestinal mucosa, and inducing apoptosis of activated T-lymphocytes through transmembrane TNF binding.
TNF-alpha (soluble and transmembrane)
Indications
- moderate to severely active Crohn's disease
- ulcerative colitis
- rheumatoid arthritis
- psoriatic arthritis
- ankylosing spondylitis
- plaque psoriasis
- juvenile idiopathic arthritis
Contraindications
- active TB or other serious infections
- sepsis
- hypersensitivity to adalimumab
Adverse Effects
Common
- injection site reactions
- upper respiratory infections
- headache
- nausea
Serious
- serious bacterial, viral, fungal opportunistic infections
- TB reactivation
- malignancy (lymphoma, especially hepatosplenic T-cell lymphoma)
- demyelinating disease
- CHF worsening (doses >5 mg/kg IV)
- lupus-like syndrome
Pharmacokinetics (ADME)
| Absorption | subcutaneous injection; bioavailability ~64% |
| Distribution | Vd ~5–6 L; primarily intravascular |
| Metabolism | proteolytic catabolism |
| Excretion | proteolytic degradation |
| Half-life | ~2 weeks |
| Onset | weeks (clinical response in 4–12 weeks) |
| Peak | 131 hours post-SC injection |
| Duration | biweekly SC dosing |
| Protein Binding | not applicable |
| Vd | 5–6 L |
Drug Interactions
| Drug / Agent | Mechanism | Severity |
|---|---|---|
| live vaccines | increased risk of infection from live vaccines during immunosuppression | major |
| abatacept or anakinra | additive immunosuppression with increased serious infection risk; generally avoid combination | major |
| methotrexate | reduces immunogenicity/ADA formation, increasing drug levels; used therapeutically | beneficial |
Nursing Considerations
- Screen for latent TB with TST or IGRA before starting; treat latent TB for at least 1 month before initiating adalimumab.
- Teach patients subcutaneous self-injection technique; auto-injector pens require refrigeration at 2–8°C; allow to warm to room temperature before injection.
- Monitor for signs of infection at every visit; hold adalimumab for serious active infections and do not restart until infection is resolved.
- Inform patients that live vaccines must be avoided; ensure completion of recommended vaccinations (including herpes zoster and pneumococcal vaccines) before starting therapy.
Clinical Pearls
- Adalimumab is the first fully human anti-TNF antibody, reducing the risk of immunogenicity compared to chimeric antibodies like infliximab; however, combination with immunomodulators (azathioprine, methotrexate) further reduces antibody formation.
- The combination of adalimumab plus an immunomodulator (e.g., azathioprine) is more effective than either agent alone for maintaining IBD remission.
Safety Profile
Pregnancy avoid
Lactation use-with-caution
Renal Adjustment Not required
Hepatic Adjustment Not required
TDM Not required
Concordance Terms
Cross-referenced clinical concepts — click any term to see all content where it appears.