These highlights do not include all the information needed to use SIMPONI ARIA ® safely and effectively. See full prescribing information for SIMPONI ARIA.
SIMPONI ARIA
(golimumab) injection, for intravenous use
Initial U.S. Approval: 2009
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
See full prescribing information for complete boxed warning.
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Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA (5.1).
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Discontinue SIMPONI ARIA if a patient develops a serious infection or sepsis (5.1).
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Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ARIA (5.1).
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Monitor all patients for active TB during treatment, even if initial latent TB test is negative (5.1).
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Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA is a member (5.2).
RECENT MAJOR CHANGES
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Dosage and Administration (2.3) |
02/2014 |
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Warnings and Precautions (5.1, 5.2, 5.9) |
12/2014 |
INDICATIONS AND USAGE
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate (1.1)
DOSAGE AND ADMINISTRATION
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2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks (2.1)
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Dilution of supplied SIMPONI ARIA solution with 0.9% w/v sodium chloride is required prior to adminis
