adalimumab-afzb

1 INDICATIONS AND USAGE ABRILADA is a tumor necrosis factor (TNF) blocker 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 . ( 1.1 ) • Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ( 1.2 ) • Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis . ( 1.3 ) • Reducing signs and symptoms in adult patients with active ankylosing spondylitis . ( 1.4 ) • Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. ( 1.5 ) • Treatment of moderately to severely active ulcerative colitis in adult patients. ( 1.6 ) Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. • 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. ( 1.7 ) • Treatment of moderate to severe hidradenitis suppurativa in adult patients. ( 1.8 ) • Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. ( 1.9 ) 1.1 Rheumatoid Arthritis ABRILADA 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. ABRILADA can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). 1.2 Juvenile Idiopathic Arthritis ABRILADA is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ABRILADA can be used alone or in combination with methotrexate. 1.3 Psoriatic Arthritis ABRILADA is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. ABRILADA can be used alone or in combination with non-biologic DMARDs. 1.4 Ankylosing Spondylitis ABRILADA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. 1.5 Crohn's Disease ABRILADA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. 1.6 Ulcerative Colitis ABRILADA 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) ] . 1.7 Plaque Psoriasis ABRILADA 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. ABRILADA 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) ] . 1.8 Hidradenitis Suppurativa ABRILADA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. 1.9 Uveitis ABRILADA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.