Monograph Details
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Gastrointestinal Tract
> Colorectal 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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In moderately-to-severely active Crohn's disease: to reduce signs/symptoms and to induce and maintain clinical remission in adult patients with inadequate response to conventional therapy; and to reduce signs/symptoms and to induce clinical remission in these patients who have also lost response to or are intolerant to infliximab. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 160mg (as 4 injections in 1 day or divided over 2 days) at week 0, then 80mg at week 2. At week 4, start maintenance of 40mg every other week. May continue aminosalicylates, corticosteroids, or immunomodulatory agents. |
| 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—2, 6 (Starter Package) |
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