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These highlights do not include all the information needed to use ADALIMUMAB-ADBM safely and effectively. See full prescribing information for ADALIMUMAB-ADBM. ADALIMUMAB-ADBM injection, for subcutaneous use Initial U.S. Approval: 2017 This product is CYLTEZO® (adalimumab-adbm). CYLTEZO (adalimumab-adbm) is biosimilarBiosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of Adalimumab-adbm has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. to HUMIRA® (adalimumab).
Medication labelWhy this: Advisory · dailymed-prescription
Adalimumab-adbm is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Adalimumab-adbm can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab-adbm is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-adbm can be used alone or in combination with methotrexate. Adalimumab-adbm is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-adbm can be used alone or in combination with non-biologic DMARDs. Adalimumab-adbm is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Adalimumab-adbm is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Adalimumab-adbm is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers [see Clinical Studies (14.7)]. Adalimumab-adbm is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adbm should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician [see Warnings and Precautions (5)]. Adalimumab-adbm is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Adalimumab-adbm is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.
- generic_name
- adalimumab-adbm
- brand_name
- isopropyl alcohol
- product_names
- Adalimumab-adbm, isopropyl alcohol
- ndc
- 82009-144, 82009-146, 82009-148, 82009-150, 82009-148-22, 82009-149, 82009-149-11, 82009-144-22, 82009-145, 82009-145-11, 82009-146-22, 82009-147, 82009-147-11, 82009-150-22, 82009-151, 82009-151-11
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en