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Simponi Aria
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
rheumatoid arthritis, mod-severe
- [2 mg/kg/dose IV q8wk]
- Start: 2 mg/kg/dose IV x1 on wk 0, 4; Info: use w/ methotrexate
psoriatic arthritis
- [2 mg/kg/dose IV q8wk]
- Start: 2 mg/kg/dose IV x1 on wk 0, 4; Info: use alone or w/ methotrexate or other non-biologic DMARDs
ankylosing spondylitis
- [2 mg/kg/dose IV q8wk]
- Start: 2 mg/kg/dose IV x1 on wk 0, 4; Info: use alone or w/ methotrexate or other non-biologic DMARDs
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: INJ
polyarticular juvenile idiopathic arthritis
- [2 yo and older]
- Dose: 80 mg/m^2/dose IV q8wk; Start: 80 mg/m^2/dose IV x 1 on wk 0, 4; Info: use w/ methotrexate
psoriatic arthritis
- [2 yo and older]
- Dose: 80 mg/m^2/dose IV q8wk; Start: 80 mg/m^2/dose IV x 1 on wk 0, 4; Info: use alone or w/ methotrexate or other non-biologic DMARDs
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]