An antirheumatic - It is used to treat several types of arthritis
FDA Alerts
Special Alerts:
[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF2, http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01879.html.
[Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF and http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm.
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Rheumatoid Arthritis in Adults
Used to manage the signs and symptoms of rheumatoid arthritis, to induce a major clinical response, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with moderate to severe active rheumatoid arthritis. Use alone or in combination with methotrexate or other DMARDs.
Juvenile Arthritis
Management of the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in children. Use with or without methotrexate.
Psoriatic Arthritis
Used to manage the signs and symptoms of active arthritis, to improve physical function, and to inhibit progression of structural damage associated with the disease in adults with psoriatic arthritis. Use alone or in combination with other DMARDs.
Used to reduce signs and symptoms of Crohn’s disease and to induce and maintain clinical remission in adults with moderately to severely active disease who have had inadequate response to conventional therapy. Also used to reduce signs and symptoms of the disease and to induce clinical remission in adults with moderately to severely active Crohn’s disease who have lost response to or are intolerant to infliximab.
Plaque Psoriasis
Management of moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and in whom other systemic therapies are medically less appropriate. Use only in patients who will be closely monitored and who will have regular follow-up visits with a clinician.
Dosage and Administration
General
Methotrexate, other DMARDs, corticosteroids, salicylates, NSAIAs, and analgesics may be continued in adults with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis.
Aminosalicylates, corticosteroids, and/or immunomodulatory agents (e.g., mercaptopurine, azathioprine) may be continued in adults with Crohn’s disease.
Administration
Sub-Q Injection
Administer by sub-Q injection every other week or every week.
Administer sub-Q injections into thighs or abdomen; do not make abdominal injections within 5.18 cm (2 inches) of the umbilicus. Rotate injection sites. Give new injections ≥2.54 cm (1 inch) from an old site; do not make injections into areas where the skin is tender, bruised, red, or hard, or into scars or stretch marks.
Intended for use under the guidance and supervision of a clinician, but may be self-administered if the clinician determines that the patient and/or their caregiver is competent to safely administer the drug after appropriate training and with medical follow-up as necessary. The initial self-administered dose should be made under the supervision of a health-care professional.
Dosage
Pediatric Patients
Pending revision, the material in this section should be considered in light of more recently available information in the MEDWATCH notification at the beginning of this monograph.
Juvenile Arthritis
Sub-Q
Children 4–17 years of age weighing 15 to <30 kg: 20 mg once every other week.
Children 4–17 years of age weighing ≥30 kg: 40 mg once every other week.
Adults
Rheumatoid Arthritis
Sub-Q
40 mg once every other week.
Patients not receiving methotrexate may obtain additional benefit from once weekly doses of 40 mg.
Psoriatic Arthritis
Sub-Q
40 mg once every other week.
Ankylosing Spondylitis
Sub-Q
40 mg once every other week.
Crohn’s Disease
Sub-Q
160 mg once on day 1 (as four 40-mg injections in one day or as two 40-mg injections per day for two consecutive days), followed by 80 mg once 2 weeks later (on day 15). Start maintenance dosage of 40 mg once every other week on day 29 (2 weeks after the 80-mg dose).
Plaque Psoriasis
Sub-Q
Initially, 80 mg followed by 40 mg once every other week (maintenance dosage) starting 1 week after the initial dose.
Prescribing Limits
Adults
Crohn’s Disease
Manufacturer states safety and efficacy of continuing adalimumab beyond 1 year have not been evaluated in clinical studies.
Plaque Psoriasis
Manufacturer states safety and efficacy of continuing adalimumab beyond 1 year have not been evaluated in clinical studies.
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