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.
Indicated in adult. for: Non-Hodgkin’s lymphoma. (NHL) for the tmt. of pts. with relaps. or refract. low-grade or folic., B-cell non-hodgkin’s lymphoma. Tmt. of previous. untreat. pts. with low-grade or folic. lymphoma in comb. with chemother. Tmt. of pts. with CD20 posit. diffuse large B-cell non-Hodgkin's lymphom. in comb. with CHOP chemother. Maintenan. ther. is indic. for the tmt. of folic. lymphom. pts. respond. to induct. ther.
CLL: in comb. with chemother. is indic. for the tmt. of pts. with previous. untreated and relaps./refract. CLL. Only limited data are available on efficacy and safety for pts. previous. treated with MABS includ. rituximab or pts. refract. to prev. rituximab plus chemother.
Granulomatosis with polyangiitis & microscopic polyangiitis: In comb. with glucocorticoids, is indic. for the tmt. of adult pts. with granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis (WG)) and microscopic polyangiitis (MPA).
C/I: For the use in non-Hodgkin’s lymphom., CLL&granulomatosis with polyangiitis & microscopic polyangiitis. Hypersens. Active, severe infec. Pts. in a severely immunocomprom. state. Specific for granulomatosis with polyangiitis & microscopic polyangiitis: Severe HF (NYHA Class IV) or severe, uncontrol. card. dis. See lit.