|
1 Indications And Usage Humira Is A Tumor Necrosis Factor (tnf) Blocker Indicated For Treatment Of: Rheumatoid Arthritis (ra) (1.1) : 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 Ra. Juvenile Idiopathic Arthritis (jia) (1.2) : Reducing Signs And Symptoms Of Moderately To Severely Active Polyarticular Jia In Patients 2 Years Of Age And Older. Psoriatic Arthritis (psa) (1.3) : Reducing Signs And Symptoms, Inhibiting The Progression Of Structural Damage, And Improving Physical Function In Adult Patients With Active Psa. Ankylosing Spondylitis (as) (1.4) : Reducing Signs And Symptoms In Adult Patients With Active As. Adult Crohn’s Disease (cd) (1.5) : Reducing Signs And Symptoms And Inducing And Maintaining Clinical Remission In Adult Patients With Moderately To Severely Active Crohn’s Disease Who Have Had An Inadequate Response To Conventional Therapy. Reducing Signs And Symptoms And Inducing Clinical Remission In These Patients If They Have Also Lost Response To Or Are Intolerant To Infliximab. Pediatric Crohn’s Disease (1.6) : Reducing Signs And Symptoms And Inducing And Maintaining Clinical Remission In Patients 6 Years Of Age And Older With Moderately To Severely Active Crohn’s Disease Who Have Had An Inadequate Response To Corticosteroids Or Immunomodulators Such As Azathioprine, 6-Mercaptopurine, Or Methotrexate. Ulcerative Colitis (uc) (1.7) : Inducing And Sustaining Clinical Remission In Adult Patients With Moderately To Severely Active Ulcerative Colitis Who Have Had An Inadequate Response To Immunosuppressants Such As Corticosteroids, Azathioprine Or 6-Mercaptopurine (6-Mp). The Effectiveness Of Humira Has Not Been Established In Patients Who Have Lost Response To Or Were Intolerant To Tnf Blockers. Plaque Psoriasis (ps) (1.8) : 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. Hidradenitis Suppurativa (hs) (1.9) : The Treatment Of Moderate To Severe Hidradenitis Suppurativa In Patients 12 Years Of Age And Older. Uveitis (uv) (1.10) : The Treatment Of Non-Infectious Intermediate, Posterior, And Panuveitis In Adults And Pediatric Patients 2 Years Of Age And Older. 1.1 Rheumatoid Arthritis Humira 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. Humira Can Be Used Alone Or In Combination With Methotrexate Or Other Non-Biologic Disease-Modifying Anti-Rheumatic Drugs (dmards). 1.2 Juvenile Idiopathic Arthritis Humira Is Indicated For Reducing Signs And Symptoms Of Moderately To Severely Active Polyarticular Juvenile Idiopathic Arthritis In Patients 2 Years Of Age And Older. Humira Can Be Used Alone Or In Combination With Methotrexate. 1.3 Psoriatic Arthritis Humira Is Indicated For Reducing Signs And Symptoms, Inhibiting The Progression Of Structural Damage, And Improving Physical Function In Adult Patients With Active Psoriatic Arthritis. Humira Can Be Used Alone Or In Combination With Non-Biologic Dmards. 1.4 Ankylosing Spondylitis Humira Is Indicated For Reducing Signs And Symptoms In Adult Patients With Active Ankylosing Spondylitis. 1.5 Adult Crohn’s Disease Humira Is Indicated For Reducing Signs And Symptoms And Inducing And Maintaining Clinical Remission In Adult Patients With Moderately To Severely Active Crohn’s Disease Who Have Had An Inadequate Response To Conventional Therapy. Humira Is Indicated For Reducing Signs And Symptoms And Inducing Clinical Remission In These Patients If They Have Also Lost Response To Or Are Intolerant To Infliximab. 1.6 Pediatric Crohn’s Disease Humira Is Indicated For Reducing Signs And Symptoms And Inducing And Maintaining Clinical Remission In Pediatric Patients 6 Years Of Age And Older With Moderately To Severely Active Crohn’s Disease Who Have Had An Inadequate Response To Corticosteroids Or Immunomodulators Such As Azathioprine, 6-Mercaptopurine, Or Methotrexate. 1.7 Ulcerative Colitis Humira Is Indicated For Inducing And Sustaining Clinical Remission In Adult Patients With Moderately To Severely Active Ulcerative Colitis Who Have Had An Inadequate Response To Immunosuppressants Such As Corticosteroids, Azathioprine Or 6-Mercaptopurine (6-Mp). The Effectiveness Of Humira Has Not Been Established In Patients Who Have Lost Response To Or Were Intolerant To Tnf Blockers [see Clinical Studies (14.7) ] . 1.8 Plaque Psoriasis Humira 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. Humira Should Only Be Administered To Patients Who Will Be Closely Monitored And Have Regular Follow-Up Visits With A Physician [see Boxed Warning And Warnings And Precautions (5) ] . 1.9 Hidradenitis Suppurativa Humira Is Indicated For The Treatment Of Moderate To Severe Hidradenitis Suppurativa In Patients 12 Years Of Age And Older . 1.10 Uveitis Humira Is Indicated For The Treatment Of Non-Infectious Intermediate, Posterior, And Panuveitis In Adults And Pediatric Patients 2 Years Of Age And Older .
|