Pharmacy Author: Omudhome Ogbru, Pharm.D.
Medical Editor: Jay Marks, M.D.

GENERIC NAME: adalimumab

BRAND NAME: Humira

DRUG CLASS AND MECHANISM: Adalimumab is an injectable protein that blocks the inflammatory effects of tumor necrosis factor alpha (TNF alpha) in rheumatoid arthritis . Two other injectable drugs--infliximab (Remicade) and etanercept (Enbrel)--also block TNF alpha. 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. The 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. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. Adalimumab is a synthetic (man-made) protein, similar to human protein, that binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and fever as well as the pain, tenderness and swelling of joints are reduced in patients with rheumatoid arthritis. In addition, the progressive destruction of the joints is slowed or prevented. Adalimumab was approved by the FDA in December, 2002.

PRESCRIPTION: yes

GENERIC AVAILABLE: no

PREPARATIONS: Prefilled glass syringe: 40 mg (0.8 ml); glass vial : 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. It also slows the progression (destruction of the joints) in moderate to severe rheumatoid arthritis. It is used after one or more other drugs that slow the destruction of the joints (referred to as disease modifying anti-rheumatic drugs or DMARDs) have failed. Adalimumab can be used alone or in combination with methotrexate or other DMARDs,

DOSING: Adalimumab is injected under the skin. The recommended dose for adults is 40 mg every other week, but some patients may need weekly administration.

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.

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.

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