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February 9, 2012

adalimumab, Humira

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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




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Suggested Reading on adalimumab, Humira by Our Doctors

  • Related Diseases & Conditions

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      • Rheumatoid arthritis is an autoimmune disease that causes chronic inflammation of the joints, the tissue around the joints, as well as other organs in the body. Because it can affect multiple other organs of the body, rheumatoid arthritis is referred to as a systemic illness and is sometimes called rheumatoid disease.
    • Crohn's Disease
      • Crohn's disease is a chronic inflammatory disease, primarily involving the small and large intestine, but which can affect other parts of the digestive system as well. Abdominal pain, diarrhea, vomiting, fever, and weight loss are common symptoms.
    • Psoriasis
      • Psoriasis is a long-term skin condition that may cause large plaques of red, raised skin, flakes of dry skin, and skin scales. There are several types of psoriasis, including psoriasis vulgaris, guttate psoriasis, inverse psoriasis, and pustular psoriasis. Symptoms vary depending on the type of psoriasis the patient has. Treatment of psoriasis may include creams, lotions, oral medications, injections and infusions of biologics, and light therapy. There is no cure for psoriasis.
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      • Sarcoidosis, a disease resulting from chronic inflammation, causes small lumps (granulomas) to develop in a great range of body tissues and can appear in almost any body organ. However, sarcoidosis most often starts in the lungs or lymph nodes.
    • Arthritis
      • Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, gout, and pseudogout.
    • Ankylosing Spondylitis
      • Ankylosing spondylitis is a type of arthritis that causes chronic inflammation of the spine. The tendency to develop ankylosing spondylitis is genetically inherited.
    • Psoriatic Arthritis
      • Psoriatic arthritis is a disease that causes skin and joint inflammation. Symptoms include painful, stiff, and swollen joints, tendinitis, and organ inflammation. Treatment involves antiinflammatory medications and exercise.
    • Juvenile Arthritis (Juvenile Rheumatoid Arthritis)
      • Juvenile arthritis (juvenile rheumatoid arthritis or JRA) annually affects one child in every thousand. There are three types of JRA: pauciarticular (less than four joints affected), polyarticular (more than four joints affected), and systemic-onset (inflamed joints with high fevers and rash). Treatment of juvenile arthritis depends upon the type the child has and should focus on treating the symptoms that manifest.
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adalimumab, Humira

What is sarcoidosis?

Sarcoidosis is a disease that results from a specific type of inflammation of tissues of the body. It can appear in almost any body organ, but it starts most often in the lungs or lymph nodes.

The cause of sarcoidosis is unknown. The disease can appear suddenly and disappear. Or it can develop gradually and go on to produce symptoms that come and go, sometimes for a lifetime.

As sarcoidosis progresses, microscopic lumps of a specific form of inflammation, called granulomas, appear in the affected tissues. In the majority of cases, these granulomas clear up, either with or without treatment. In the few cases where the granulomas do not heal and disappear, the tissues tend to remain inflamed and become scarred (fibrotic).

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