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Kevzara
sarilumab
Black Box Warnings .
Serious Infection Risk
incr. risk of serious infection leading to hospitalization or death; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections observed; most infections occur in combo w/ other immunosuppressants; weigh risk/benefit in pts w/ chronic or recurrent infection; avoid use in pts w/ active infection; screen for latent TB infection before and during sarilumab tx; initiate anti-TB tx before sarilumab tx; monitor closely for infection s/sx during tx, incl. TB development in pts w/ negative TB test; D/C sarilumab if serious infection develops
Adult Dosing .
Dosage forms: INJ (pen): 150 mg per injection, 200 mg per injection; INJ (pre-filled syringe): 150 mg per 1.14 mL, 200 mg per 1.14 mL
rheumatoid arthritis, moderate-severe
- [200 mg SC q2wk]
- Info: use as monotherapy or w/ methotrexate or other non-biologic DMARDs; see pkg insert for dose adjustments based on AST/ALT, ANC, and Plt
polymyalgia rheumatica
- [200 mg SC q2wk]
- Info: use w/ corticosteroid taper or as monotherapy following corticosteroid; D/C tx if AST or ALT >3x ULN, ANC <1000 at dosing interval end, or Plt <100,000
COVID-19 (off-label)
- [400 mg IV x1]
- Info: for hospitalized pts w/ severe COVID-19 and elevated systemic inflammatory markers; not 1st-line agent; use prefilled syringe to make IV infusion
renal dosing
- [SC route]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
- [IV route]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- active hepatic dz or baseline AST/ALT >1.5x ULN: avoid use
Peds Dosing .
- Dosage forms: INJ (pre-filled syringe): 200 mg per 1.14 mL
polyarticular juvenile idiopathic arthritis
- [2 yo and older, >63 kg]
- Dose: 200 mg SC q2wk; Max: 200 mg/dose; Info: use as monotherapy or w/ other non-biologic DMARDs; hold tx if ALT 3.1-5x ULN, ANC 500-999, or Plt 50,001-100,000; D/C tx if ALT >5x ULN, ANC <500 w/ infection, or Plt <50,000
renal dosing
- [see below]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- active hepatic dz or baseline AST/ALT >1.5x ULN: avoid use