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- What is adalimumab, and how does it work (mechanism of action)?
- What brand names are available for adalimumab?
- Is adalimumab available as a generic drug?
- Do I need a prescription for adalimumab?
- What are the side effects of adalimumab?
- What is the dosage for adalimumab?
- Is adalimumab safe to take if I'm pregnant or breastfeeding?
- What else should I know about adalimumab?
What is adalimumab, and how does it work (mechanism of action)?
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.
What are the side effects of adalimumab?
The most common side effects are:
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.
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What is the dosage for adalimumab?
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.
Is adalimumab safe to take if I'm pregnant or breastfeeding?
Adalimumab has not been adequately studied in pregnant women.
Use of adalimumab by nursing mothers has not been adequately evaluated.
What else should I know about adalimumab?
What preparations of adalimumab are available?
Prefilled glass syringe: 20 mg/0.4 ml and 40 mg/0.8 ml; Prefilled pen: 40 mg/0.8 ml.
How should I keep adalimumab stored?
Adalimumab should be refrigerated at 2-8 C (36-46 F).
Reference: FDA Prescribing Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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Rheumatoid ArthritisRheumatoid arthritis (RA) 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.
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SarcoidosisSarcoidosis, 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.
Scalp PsoriasisScalp psoriasis causes red, raised, scaly patches that may extend from the scalp to the forehead and the back of the neck and ears. Symptoms and signs include itching, hair loss, flaking, silvery scales, and red plaques. Treatment includes topical medicated shampoos, creams, gels, oils, ointments, and soaps, medications, and light therapy.
ScleritisScleritis is inflammation of the white part of the eye. It may be caused by a serious underlying condition, such as an autoimmune disease. Symptoms include redness, pain, tearing, sensitivity to light, and decreased visual acuity. Treatment may include eye drops as well as treatment for any underlying disease process. Scleritis cannot be prevented.
Tuberculosis Skin Test (PPD Skin Test)The tuberculosis skin test is based on the fact that infection with M. tuberculosis produces a delayed-type hypersensitivity skin reaction to certain components of the bacterium. The standard recommended tuberculin test is administered by injecting 0.1mL of 5 TU (tuberculin units) PPD into the top layers of skin of the forearm. "Reading" the skin test means detecting a raised, thickened local area of skin reaction, referred to as induration. The area of induration (palpable, raised, hardened area) around the site of injection is the reaction to tuberculin.