Europe — EMA
Humira (Adalimumab)
Humira (adalimumab) is an EU‑approved TNF inhibitor injection used for rheumatoid arthritis, Crohn's disease, psoriasis and other autoimmune conditions.
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What is Adalimumab?
Humira is a prescription medication that contains the active ingredient adalimumab, supplied as a subcutaneous injection. It is a biologic immunosuppressant classified as a tumor necrosis factor (TNF) inhibitor, marketed in the European Union for the treatment of several inflammatory and autoimmune conditions.
What is Adalimumab used for?
Humira is indicated for a range of chronic inflammatory diseases where modulation of the immune response is required.
- Rheumatoid arthritis in adults who have not responded adequately to conventional therapy. - Psoriatic arthritis to reduce joint pain and skin lesions. - Ankylosing spondylitis for improvement of spinal mobility. - Moderate to severe Crohn's disease and ulcerative colitis. - Plaque psoriasis when other systemic treatments are insufficient. - Hidradenitis suppurativa and non-infectious uveitis as adjunct therapy.
What are the side effects of Adalimumab?
Adalimumab may cause a variety of adverse reactions, ranging from mild to severe. Patients should be aware of both common and serious potential effects.
Common: - Injection site pain, redness, or swelling. - Upper respiratory tract infections such as sinusitis or nasopharyngitis. - Headache and fatigue. - Nausea or mild gastrointestinal discomfort. - Mild rash or itching.
Serious: - Serious infections including tuberculosis, bacterial sepsis, or opportunistic fungal infections. - Reactivation of hepatitis B virus. - Development of malignancies such as lymphoma. - Neurological disorders including demyelinating disease. - Severe allergic reactions (anaphylaxis, serum sickness).
What precautions apply to Adalimumab?
Before starting Humira, patients and clinicians should consider several safety factors.
- Screen for latent tuberculosis and hepatitis B; treat active infections before initiating therapy. - Evaluate for a history of malignancy, especially lymphoma or skin cancers. - Monitor for signs of infection throughout treatment. - Use caution in patients with congestive heart failure or demyelinating disorders. - Discuss pregnancy and breastfeeding plans, as safety data are limited. - Regular laboratory monitoring (CBC, liver enzymes) may be recommended. - Vaccinations should be up to date before treatment, avoiding live vaccines during therapy.
What does Adalimumab interact with?
Humira can influence the activity of other medicines, and some combinations require special attention.
Avoid: - Live vaccines (e.g., yellow fever, BCG) because immunosuppression may increase infection risk. - Concurrent use with other biologic immunosuppressants (e.g., abatacept, rituximab) due to heightened infection risk.
Use with caution: - Systemic corticosteroids, as combined immunosuppression may raise infection susceptibility. - Methotrexate or azathioprine, which can augment immunosuppressive effects. - Antiviral agents for hepatitis B, requiring close monitoring of viral load. - Drugs that affect wound healing (e.g., NSAIDs) when surgery is planned. - Concomitant antibiotics, ensuring appropriate coverage for opportunistic pathogens.



