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 10 mg/ml. Concentr. for sol. for infusion 1 x 100 mg / 10 ml , 1 x 500 mg / 50 ml
For NHL, GPA, MPA, dose is: 375 mg/m2 body surface. For RA and PV: two 1000 mg infusions at 2 weeks apart. See prescribing information for full details
Non-Hodgkin’s lymphoma (NHL): for pts. with relapsed or refract. low-grade or follicular, B-cell NHL. For previous. untr. pts. with low-grade or follicular lymphoma in combin. with chemoth. For pt.s with CD20 posit. diffuse large B-cell NHL in combin. with CHOP chemot.Maint. ther. for follicular lymphoma pts. respon. to induct. therapy.Chronic lymphocytic leukaemia (CLL): in combin. with chemoth. for pts. with previous. untr. and relapsed/refract. chron. lymphocytic leukaemia. Rheumatoid arthritis (RA): in combin. with methotrexate, to reduce signs and sympts. in adlt. pts. with mod. to sev. act. RA who had inadeq. respon. or intol. to one or more TNF antagonist ther. Granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA): in combin. with glucocortic. for adlt. pts. with GPA (Wegener’s Granulomatosis (WG)) and MPA.Pemphigus vulgaris (PV): for adlt. pts. with mod. to sev. PV.
C/I: Hypersens.
Act., sev. infect.
Pts sev. immunocompromised.
Sev. HF (Class IV) or sev., unctrolled. cardiac dis. for use in RA, GPA, MPA and PV only
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.
