adalimumab, Humira

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GENERIC NAME: adalimumab

BRAND NAME: Humira

DRUG CLASS AND MECHANISM: Adalimumab is an injectable protein(antibody) that blocks the inflammatory effects of tumor necrosis factor alpha (TNF alpha) in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn 's disease of the intestine. Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is a protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints. In the case of Crohn's disease, the signs of inflammation include fever, abdominal pain, and diarrhea. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. The inflammation in Crohn's disease can lead to strictures (narrowing) of the intestine or intestinal perforation. Adalimumab is a synthetic (man-made) antibody that binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its consequences in the joints and intestine are reduced. In arthritis, the progressive destruction of the joints is slowed or prevented. Adalimumab is a disease modifying anti-rheumatic drugs (DMARD) because it slows or prevents destruction of joints. Adalimumab was approved by the FDA in December 2002.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS: Prefilled glass syringe: 20 mg/0.4 ml and 40 mg/0.8 ml; Prefilled pen: 40 mg/0.8 ml.

STORAGE: Adalimumab should be refrigerated at 2-8 C (36-46 F).

PRESCRIBED FOR: Adalimumab is used for reducing the signs and symptoms of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, juvenile idiopathic arthritis, and Crohn's disease. It also slows the progression (destruction of the joints) and improves physical function in moderate to severe rheumatoid arthritis. Adalimumab can be used alone or in combination with methotrexate (Rheumatrex, Trexall) or other DMARDs.

DOSING: Adalimumab is injected under the skin. The recommended dose for rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis is 40 mg every other week, but some patients may need weekly administration.

Crohn's disease is treated with 160 mg initially, followed by 80 mg two weeks later, then 40 mg every 2 weeks.

Juvenile idiopathic arthritis is treated with 20 or 40 mg every other week and plaque psoriasis is treated with 80 mg followed by 40 mg every other week.

DRUG INTERACTIONS: Methotrexate reduces the absorption of adalimumab by 29%-49%, but no adjustments to the dose of adalimumab need to be made when methotrexate is given concomitantly. Serious infections are more likely to occur when adalimumab is combined with anakinra (Kineret). Adalimumab may interfere with the effectiveness of vaccines. Live vaccines, including attenuated vaccines, should not be used while patients are being treated with adalimumab.

PREGNANCY: Adalimumab has not been adequately studied in pregnant women.

NURSING MOTHERS: Use of adalimumab by nursing mothers has not been adequately evaluated.

SIDE EFFECTS: The most common side effects are headache, rash, nausea and stomach upset. Adalimumab may cause swelling, redness, pain and itching at the site of injection. Adalimumab suppresses the immune system and is therefore associated with minor infections of the urinary tract, respiratory tract, and sinuses. Like other drugs that block TNF, use of adalimumab also has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections. Individuals with active infections should not be treated with adalimumab. Adalimumab also may worsen the symptoms of diseases of the nervous system. In studies some patients who used adalimumab or other TNF blocking drugs developed cancer. Since patients with rheumatoid arthritis have a higher rate of cancers than the general population, the connection between cancer and use of adalimumab is unclear. Other side effects of adalimumab include hypersensitivity reactions (including anaphylaxis) and reduced levels in the blood of platelets and red cells (aplastic anemia). Adalimumab may increase the risk of reactivating hepatitis B virus in chronic carriers of the virus.

Reference: FDA Prescribing Information


Last Editorial Review: 3/21/2012




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