Monograph Details
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Musculoskeletal Disorders
> Arthritis/rheumatic disorders
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HUMIRA |
| Manufacturer |
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Abbott Laboratories |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Tumor necrosis factor-α blocker. |
| Generic Name |
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Adalimumab 20mg/0.4mL, 40mg/0.8mL; soln for SC inj; preservative-free. |
| Indications |
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To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in moderately-to-severely active rheumatoid arthritis (RA); may be used alone or with methotrexate (MTX) or DMARDs. To reduce signs/symptoms of moderately-to-severely active polyarticular juvenile idiopathic arthritis in patients ≥4 years of age; may be used alone or with MTX. To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in active psoriatic arthritis; may be used alone or with DMARDs. To reduce signs and symptoms of active ankylosing spondylitis. |
| Children |
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<4yrs or <15kg: not recommended. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. 4–17yrs: (15kg to <30kg): 20mg every other week (20mg prefilled syringe should be used); (≥30kg): 40mg every other week. May use with MTX, glucocorticoids, salicylates, NSAIDs, or analgesics. |
| Adults |
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Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 40mg every other week. May use with MTX, DMARDs, glucocorticoids, salicylates, NSAIDs, or analgesics. RA (without MTX): may increase frequency to once weekly. |
| Contraindications |
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Concurrent anakinra: not recommended. Sepsis. Clinically important, active infection. Concurrent live vaccines or other TNF blockers. |
| Precautions |
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Chronic or history of recurring infections. Conditions that predispose to infection. Test for tuberculosis; treat TB first. Monitor closely if new infection develops; discontinue if serious infection or sepsis develops. CHF. Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. CNS demyelinating disorders. Juvenile arthritis: follow up on current immunizations before starting therapy. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Adverse Reactions |
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Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma), blood dyscrasias, hypertension, neurological events, antibody formation, lupus-like syndrome. |
| How Supplied |
Single-dose prefilled syringe—2
Single-dose prefilled pen (40mg)—2 |
| Additional Resources |
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• Related Prescribing Note |
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