Always give premed consisting of analgesic/antipyretic & antihistaminic drug before each administration of MabThera/MabThera SC.
Patients w/ RA, PV or adult & childn w/ GPA or MPA Administer 100 mg IV methylprednisolone to be completed 30 min prior to each infusion.
Patients w/ CLL & lymphocyte count >25 x 109 L Administer 100 mg prednisone/prednisolone IV shortly before administration w/ MabThera/MabThera SC.
MabThera 1st IV infusion: Initially 50 mg/hr. Escalated after 30 min in 50 mg/hr increments every 30 min to max of 400 mg/hr. Subsequent IV infusions: Initially 100 mg/hr & increased by 100 mg/hr increments every 30 min to max of 400 mg/hr.
Low-grade or follicular non-Hodgkin's lymphoma Initial treatment: IV monotherapy: 375 mg/m
2 as IV infusion once wkly for 4 wk. IV combination therapy: 375 mg/m
2/cycle for total of 8 cycles R-IV w/ CVP (21 days/cycle); 8 cycles R-IV w/ MVP (28 days/cycle); 8 cycles R-IV w/ CHOP (21 days/cycle); 6 cycles if complete remission is achieved after 4 cycles; 6 cycles R-IV w/ CHVP-Interferon (21 days/cycle). Administer on day 1 of each cycle after IV administration of glucocorticoid component of chemotherapy if applicable.
Patients who do not experience Grade 3 or 4 infusion-related adverse event w/ Cycle 1 Start alternative infusion at rate of 20% of total dose given in the 1st 30 min & remaining 80% of total dose given over next 60 min. Re-treatment following relapse: 375 mg/m
2 as IV infusion once wkly for 4 wk.
Previously untreated patients after response to induction treatment Maintenance treatment: 375 mg/m
2 once every 2 mth until disease progression. Max: 2 yr (12 infusions in total).
Relapsed/refractory patients after response to induction treatment Maintenance treatment: 375 mg/m
2 once every 3 mth until disease progression. Max: 2 yr (8 infusions in total). Re-treatment following relapse: Initially 375 mg/m
2 as IV infusion.
Diffuse large B-cell non-Hodgkin's lymphoma 375 mg/m
2 administered on day 1 of each cycle for 8 cycles after IV administration of glucocorticoid component of CHOP.
Patients who do not experience Grade 3 or 4 infusion-related adverse event w/ Cycle 1 Start alternative infusion at rate of 20% of total dose given in the 1st 30 min & the remaining 80% of total dose given over the next 60 min.
Chronic lymphocytic leukaemia 375 mg/m
2 administered on day 1 of 1st cycle followed by 500 mg/m
2 on day 1 of each subsequent cycle for 6 cycles in total.
RA Initially 1,000 mg by IV infusion followed 2 wk later by 2nd 1,000 mg IV infusion.
Patients who do not experience serious infusion-related adverse event Initiate at rate of 250 mg/hr for 1st 30 min & then 600 mg/hr for the next 90 min.
Granulomatosis w/ polyangiitis (Wegener's) & microscopic polyangiitis Adult Induction of remission: 375 mg/m
2 as IV infusion once wkly for 4 wk. Administer methylprednisolone 1,000 mg daily IV for 1-3 days followed by oral prednisone 1 mg/kg daily (max: 80 mg daily) tapered as rapidly as possible during & after 4 wk induction course. Maintenance treatment: Administer as two 500 mg IV infusions separated by 2 wk, followed by 500 mg IV infusion at mth 6, 12, & 18 & then every 6 mth thereafter.
Childn 375 mg/m
2 as IV infusion once wkly for 4 wk. Prior to 1st MabThera IV infusion, administer methylprednisolone IV for 3 daily doses of 30 mg/kg (max: 3 additional daily doses) followed by oral prednisone 1 mg/kg daily (max: 60 mg daily) tapered as rapidly as possible. Maintenance treatment: Administer as two 250 mg IV infusions separated by 2 wk, followed by 250 mg IV infusion every 6 mth thereafter.
Pemphigus vulgaris 1,000 mg as IV infusion followed by 2 wk later by a 2nd 1,000 mg IV infusion in combination w/ a tapering course of glucocorticoids. Maintenance treatment: Administer 500 mg IV infusions at mth 12 & then every 6 mth thereafter. Treatment of relapse: Administer 1,000 mg IV, & subsequent infusions no sooner than 16 wk following last infusion.
MabThera SC Non-Hodgkin's lymphoma 1,400 mg over approx 5 min.
Low-grade or follicular non-Hodgkin's lymphoma All patients must always receive their 1st dose of MabThera by IV inj. The SC formulation should only be given at the 2nd or subsequent cycles. 1st administration: IV: 375 mg/m
2 by IV infusion. Subsequent administrations: SC: Initial treatment: SC monotherapy: 1,400 mg once wkly for 3 wk following IV at wk 1 (1st wk R-IV then 3 wk R-SC; 4 wk in total). SC combination therapy: Administer on day 0 or day 1 of each cycle after administration of glucocorticoid component of chemotherapy, if applicable. Re-treatment following relapse: Initially 1,400 mg as SC inj once wkly, following 1st administration of 375 mg/m
2 as IV infusion (1st week R-IV then 3 wk R-SC; 4 wk in total).
Previously untreated patients after response to induction treatment Maintenance treatment: 1,400 mg once every 2 mth until disease progression or max: 2 yr (12 infusions in total).
Relapsed refractory patients after response to induction treatment Maintenance treatment: 1,400 mg once every 3 mth until disease progression or max: 2 yr (8 infusions in total).
Diffuse large B-cell non-Hodgkin's lymphoma All patients must always receive their 1st dose of MabThera by IV inj. The SC formulation should only be given at the 2nd or subsequent cycles. Should be used in combination w/ CHOP chemotherapy. 1st administration: IV: 375 mg/m
2 by IV infusion. 2nd administration: SC: 1,400 mg administered on day 1 of each cycle for 8 cycles (1st cycle R-IV w/ CHOP + 7 cycles R-SC w/ CHOP; 8 cycles in total) after IV administration of glucocorticoid component of CHOP.
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