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Indications:
Rheumatoid Arthritis (RA)
IXIFI, in combination with methotrexate (MTX), is indicated for:
The reduction of signs and symptoms as well as the improvement in physical function in
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patients with active disease when the response to disease-modifying drugs, including MTX, has been inadequate.
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patients with severe, active and progressive disease not previously treated with MTX or other disease-modifying anti-rheumatic drugs (DMARDs).
In these patient populations, a reduction in the rate of the progression of joint damage, as measured by X-ray, has been demonstrated.
Crohn’s Disease
IXIFI is indicated for:
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Treatment of moderately to severely, active Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
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Treatment of fistulizing Crohn’s disease, in patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Pediatric Crohn’s Disease
IXIFI is indicated for:
Treatment of severe, active Crohn’s disease, in pediatric patients aged 6 to 17 years, who have not responded to conventional therapy including a corticosteroid, an immunomodulator and primary nutrition therapy; or who are intolerant to or have contraindications for such therapies. Infliximab has been studied only in combination with conventional immunosuppressive therapy.
Ulcerative Colitis
IXIFI is indicated for:
Treatment of moderately to severely active ulcerative colitis (UC) in patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Pediatric Ulcerative Colitis
IXIFI 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 UC who have had an inadequate response to conventional therapy.
Ankylosing Spondylitis
IXIFI is indicated for:
Treatment of ankylosing spondylitis, in patients who have severe axial symptoms, elevated serological markers of inflammatory activity and who have responded inadequately to conventional therapy.
Psoriatic Arthritis
IXIFI, in combination with MTX, is indicated for:
Treatment of active and progressive psoriatic arthritis in patients who have responded inadequately to DMARDs.
Psoriasis
IXIFI is indicated for:
Treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA (See Section 5.1).
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