AMGEVITA® (adalimumab)
Product License No. 001098
Rheumatoid Arthritis
AMGEVITA is indicated for reducing signs and symptoms, including major clinical response and clinical remission, and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis and had an inadequate response to one or more than one disease-modifying anti-rheumatic drugs (DMARDs).
AMGEVITA can be used alone or in combination with methotrexate (MTX) or other DMARDs.
Psoriatic Arthritis
Indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous DMARD treatment has been inadequate.
AMGEVITA can be used alone or in combination with MTX or other DMARDs.
Ankylosing Spondylitis
Indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
Crohn's Disease
Indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely Crohn's disease who have had an inadequate response to conventional therapy.
AMGEVITA is also indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderate to severe CD who had lost response to or are intolerant to infliximab.
Plaque Psoriasis
Indicated for treating adult patients with moderate to severe plaque psoriasis who had lost response to, had a contraindication to, or are intolerant to other systematic treatments, including cyclosporine, MTX or other photochemical therapies.
Ulcerative Colitis
AMGEVITA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who had an inadequate response to conventional therapy including corticosteroids and/or 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Intestinal Behcet's Disease
AMGEVITA is indicated for use in patients with Intestinal Behcet's Disease who have lost response to conventional treatment.
Hidradenitis Suppurativa
AMGEVITA is indicated for the treatment of moderate to severe hidradenitis suppurativa (also known as acne inversa) in adult patients with an inadequate response to conventional systematic therapy.
Uveitis
AMGEVITA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids or in whom corticosteroid treatment is inappropriate.
Indications and Usage for Pediatric Patients
Juvenile Idiopathic Arthritis
AMGEVITA in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more DMARDs.
AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment is inappropriate.
Pediatric Crohn's Disease
AMGEVITA is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderate to severe CD who have had an inadequate response to corticosteroids and immunomodulators.
AMGEVITA® Approved Package Insert
AMGEVITA® Approved Medication Guide