These highlights do not include all the information needed to use SIMPONI safely and effectively. See full prescribing information for SIMPONI.
SIMPONI (golimumab) injection, for subcutaneous 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 (5.1)
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Discontinue SIMPONI 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 (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 is a member (5.2)
RECENT MAJOR CHANGES
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Warnings and Precautions (5.2) |
12/2014 |
INDICATIONS AND USAGE
SIMPONI is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:
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Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (1.1)
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Active psoriatic arthritis (PsA) alone, or in combination with methotrexate (1.2)
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Active ankylosing spondylitis (AS) (1.3)
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Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy (1.4)
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inducing and maintaining clinical response
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improving endoscopic appearance of the mucosa during induction
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inducing clinical remission
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achieving and sustaining clinical remission in induction responders
DOSAGE AND ADMINISTRATION
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RA, PsA, and AS: 50 mg administered by subcutaneous injection once a month (2.1)
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UC: 200 mg initially administered by subcutaneous injection at Week 0, followed by 100 mg at Week 2 and then 100 mg every 4 weeks (2.2)
DOSAGE FORMS AND STRENGTHS
Injection (3):
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50 mg/0.5 mL in a single dose prefilled SmartJect® autoinjector
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50 mg/0.5 mL in a single dose prefilled syringe
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100 mg/1 mL in a single dose prefilled SmartJect® autoinjector
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100 mg/1 mL in a single dose prefilled syringe
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
