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Simponi
golimumab
Black Box Warnings .
Serious Infection Risk
weigh tx benefit vs. risk in pts w/ chronic or recurrent infection; pulmonary and extrapulmonary tuberculosis (TB), invasive fungal infections, and other opportunistic infections incl. Legionella and Listeria observed; some infections have been fatal; most infections occur in combo w/ other immunosuppressants; evaluate for TB risk factors and screen for latent TB infection before and during golimumab tx; initiate anti-TB tx before golimumab tx; monitor for infection s/sx during and after golimumab tx; since active TB has developed in pts w/ negative tuberculin skin test, monitor all pts for active TB s/sx; since histoplasmosis may be present in pts w/ negative antigen and antibody tests, consider empiric antifungal tx in pts w/ severe systemic illness if at risk for invasive fungal infection; D/C golimumab tx if serious infection or sepsis occurs
Malignancy
lymphoma and other malignancies, some fatal, reported in children and adolescents treated w/ TNF blockers
Adult Dosing .
Dosage forms: INJ (SmartJect auto-injector): 50 mg, 100 mg; INJ (pre-filled syringe): 50 mg per 0.5 mL, 100 mg per mL
rheumatoid arthritis, mod-severe
- [50 mg SC qmo]
- Info: use w/ methotrexate
psoriatic arthritis
- [50 mg SC qmo]
- Info: use alone or w/ methotrexate or other non-biologic DMARDs
ankylosing spondylitis
- [50 mg SC qmo]
- Info: use alone or w/ methotrexate or other non-biologic DMARDs
ulcerative colitis, mod-severe
- [100 mg SC q4wk]
- Start: 200 mg SC x1, then 100 mg SC x1 in 2wk, then 100 mg SC q4wk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.