All the Active Ingredient Drugs
Monoclonal Antibody. Rituximab 10 mg/ml. VIALS (conc. for sol. for infus.): 2 x 100
mg/10 ml; 1 x 500 mg/50 ml. NHL: 375
mg/m2 as cont. infus: In prev. untreat.
pts: In comb. with chemother. given on
day 1 of ea. cycle for 8 cycles. In
relapsed/refract. pts: As single agent 1
wkly for 4 doses. Prev. untreat. pts:
Mainten. ther: 375 mg/m2 bdy surface
1 x every 2 mths until dis. progr./max.
2 yrs. Pts. respond. to induct. tmt. may
receive maint. ther. at 375 mg/m2 bdy
surface 1 x every 3 mths until dis.
progress or for max. period 2 years.
Chron. lymphocytic leuk. (CLL): 375
mg/m2 on day 1 of 1st tmt cycle, foll.
by 500 mg/m2 on day 1 of ea.
subsequent cycle for 6 cycles total.
ANCA-associated Vasculitis (AAV): 375
mg/m2 body surface, as I.V. infus 1 x
wkly for 4 wks. Methylprednisolone
1,000 mg I.V. dly for 1-3 days is
recommend. to treat severe vasculitis
sympts, follow. by oral prednisone 1
mg/kg/day (max. 80 mg/day), and
tapered as rapidly as poss. per clin.
need) during and aft. tmt.
Tmt. previous untreated pts. with III-IV
follicular lymphoma in comb. with
chemother. Tmt. relapsed or refract. lowgrade
or follicular B-cell non-Hodgkin’s
lymphoma, CD20 positive diffuse large
B-cell non-Hodgkin’s lymphoma in comb. with CHOP chemother. Maint. ther. for
tmt. follic. lymphoma pts. respond. to
induct. ther. First line tmt. chron.
lymphocytic leuk. (CLL) in comb. with
chemother. Rheum. arthrit: In comb. with
methotrexate, to reduce signs and sympts.
in adult pts. with mod-severe active RA
who had inad. response/intol. to one or
more TNF antagonist ther. ANCAassociated
vasculitis (AAV): In combinat.
with glucocorticoids, tmt. of adults with
Wegener’s Granulomatosis (WG) and
Microscopic Polyangiitis (MPA).
Monoclonal Antibody. Rituximab 100 mg, 500 mg. VIAL (concentr. for sol. for infus.): 1×50ml, 2×10ml. Dosage must be adjust. individ. for each pt.
CLL: In comb. with chemother. is indic. for the tmt. of pts. with previos. untreated and relapsed/refract. CLL. Only limited data are available on effic. and safety for pts. previous. treated with MABs include. rituximab or pts. refract. to prev. rituximab plus chemother.
Granulomatosis with polyangiitis and microscopic polyangiitis.
In combin. with glucocorticoids, is indic. for the tmt. of adult pts. with granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis (WG)) & microscopic polyangiitis (MPA).
C/I: For use in CLL: Hypersens., Active, sev. infec., Pts. in a sev. immunocomprom. state. For use in granulomatosis with polyangiitis and microscopic polyangiitis: Hypersens. to the active subst./murine proteins., Active, sev. infec., Pts. in a sev. immunocomprom. state., Severe HF (New York Heart Association Class IV) or sev., uncontrol. cardiac dis.