In combination w/ MTX for treatment of moderate to severe active RA. Alone or in combination w/ MTX for treatment of moderate to severe active psoriatic arthritis. Treatment of active ankylosing spondylitis in patients who have had an inadequate response to conventional therapies. Treatment of severe active non-radiographic axial spondyloarthritis w/ objective signs of inflammation in patients who have had an inadequate response to, or are intolerant to NSAIDs. Treatment of moderate to severe active ulcerative colitis in patients who have had an inadequate response to, or have medical contraindications for, conventional therapy.
Adult RA, psoriatic arthritis, ankylosing spondylitis & non-radiographic axial spondyloarthritis 50 mg SC once a mth, on the same date each mth. Ulcerative colitis Initially 200 mg SC at wk 0, followed by 100 mg at wk 2, then 50 mg every 4 wk, thereafter. Maintenance: 100 mg every 4 wk can be considered.
Discontinue immediately in case of any serious allergic or anaphylactic reaction. Risk of serious infections including sepsis, TB, invasive fungal & other opportunistic infections. Do not initiate treatment in patients w/ active infection, including chronic or localized infections. Evaluate patients for both active & latent TB before starting treatment. Discontinue treatment if patient develops serious infection or sepsis. Associated w/ HBV reactivation in patients who are chronic HBV carriers. Reports of lymphoma & other malignancies; worsening or new onset CHF; hematologic reactions. Potential to affect host defenses against infections & malignancies. May result in the formation of Abs. Discontinue treatment if patient develops symptoms of a lupus-like syndrome. TNF-blocking agents have been associated w/ cases of new onset or exacerbation of CNS demyelinating disorders. Limited safety experience in patients who have undergone surgical procedures, including arthroplasty. Latex sensitivity. Do not concurrently give w/ live vaccines or therapeutic infectious agents. Not recommended w/ anakinra; abatacept; other biological therapeutics. Minor influence on the ability to drive & use machines. Specific studies have not been conducted in patients w/ renal or hepatic impairment. Caution in patients w/ hepatic impairment; elderly. Women of childbearing potential must use adequate contraception during treatment & for at least 6 mth after the last treatment. Pregnancy & lactation. Safety & efficacy have not been established in ped patients <18 yr.
Increased risk of adverse events w/ abatacept, anakinra, or other biological therapeutics. Risk of clinical infections w/ live vaccines or therapeutic infectious agents. Monitor effects/drug conc of CYP450 substrates w/ narrow therapeutic index eg, warfarin, cyclosporine or theophylline.
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