Discontinue use if anaphylactic reaction or other serious hypersensitivity reaction occurs. Not to be initiated in patients w/ active infections. Patients w/ history of recurring infections or underlying condition which may predispose to infection; history of intestinal ulceration/diverticulitis. Screen patients for latent TB infection prior to therapy. Not to be given concurrently w/ live & live attenuated vaccines. Viral reactivation in RA. Observe for symptoms potentially indicative of new onset central demyelinating disorders. Patients w/ low neutrophil count ie, absolute neutrophil count (ANC) <2 x 109
/L; not recommended in patients w/ ANC <0.5 x 109
/L; monitor neutrophil count 4-8 wk after initiation & thereafter, in RA; monitor neutrophil count at the time of 2nd infusion, in pJIA & sJIA. Perform lipid parameter assessment 4-8 wk following initiation of therapy. Increased risk of CV disorders & malignancy (in patients w/ RA). Not recommended for use in combination w/ other biological agents. Infusion reactions during & w/in 24 hr treatment. Patients on controlled Na diet. Severe renal impairment. Active hepatic disease or impairment. Patients w/ elevated ALT or AST >1.5 x ULN; not recommended in patients w/ ALT or AST >5 x ULN; monitor ALT & AST levels every 4-8 wk for the 1st 6 mth of treatment followed by every 12 wk thereafter, in RA, pJIA & sJIA. Women of childbearing potential must use effective contraception during & up to 6 mth after treatment. Pregnancy & lactation. IV
Macrophage activation syndrome may develop in sJIA patients. Childn <2yr. SC
Childn from birth to <18 yr.