Medications and Drugs

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, 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. 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. 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) protein, similar to human protein, 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 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, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease. It also slows the progression (destruction of the joints) and improves physical function (in adults) 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. In arthritis, adalimumab can be used alone or in combination with methotrexate or other DMARDs. Adalimumab is used similarly (alone or in combination with DMARDS) for the treatment of ankylosing spondylitis, psoriatic arthritis,and Crohn's disease.

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. Serious infections are more likely to occur when adalimumab is combined with anakinra (Kineret).

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).

Reference: FDA Prescribing Information

Last Editorial Review: 7/19/2007

Printer-Friendly Format

|

Email to a Friend

Back to Medications Index