Mabthera Vials 10mg/ml Concentrate for Solution for Infusion

Manufacturer
ROCHE DIAGNOSTICS GMBH
 
Contents
Rituximab
 
Indication
Relapsed or chemoresistant low-grade or follicular, CD20 +ve, B-cell non-Hodgkin's lymphoma (NHL); previously untreated patients w/ stage III-IV follicular lymphoma (FL) in combination w/ chemotherapy; maintenance treatment in FL after response to induction therapy; CD20 +ve diffused large B-cell (DLBCL) non-Hodgkin's lymphoma in combination w/ CHOP chemotherapy. In combination w/ chemotherapy for previously untreated & relapsed/refractory CD20 +ve chronic lymphocytic leukemia (CLL). In combination w/ methotrexate (MTX) in adult patients w/ active RA & inadequate response or intolerance to ≥1 tumor necrosis factor (TNF) inhibitor therapies. In combination w/ glucocorticoids for adult patients w/ severe active granulomatosis w/ polyangiitis (Wegener's) (GPA) & microscopic polyangiitis (MPA).
 
Instruction
FL & FL retreatment after relapse Monotherapy: Initially 375 mg/m² as IV infusion once wkly for 4 wk. FL in combination w/ chemotherapy 375 mg/m² as IV infusion on day 1 of each cycle after IV administration of glucocorticoid component of chemotherapy. FL maintenance treatment Previously untreated patient 375 mg/m² as IV infusion once every 2 mth until disease progression or max period of 2 yr. Relapse/refractory patient 375 mg/m² as IV infusion once every 3 mth until disease progression or max period of 2 yr. DLBCL 375 mg/m² as IV infusion on day 1 of each CHOP cycle for total of 8 cycles. CLL 375 mg/m² as IV infusion on day 1 of 1st chemotherapy cycle followed by 500 mg/m² as IV infusion on day 1 of each subsequent cycle for total of 6 cycles. Chemotherapy should be given after MabThera infusion. RA 2 1,000 mg IV infusion 2 wk apart. GPA & MPA 375 mg/m² once wkly for 4 wk. Severe vasculitis: Methylprednisolone 1,000 mg IV daily in combination w/ MabThera followed by oral prednisone 1 mg/kg daily (not to exceed 80 mg daily) during & after MabThera.
 
Drug interaction
Increased risk of renal toxicity w/ cisplatin.Potentially Fatal: May decrease the efficacy of vaccines and increase the risk of infections in patients immunised w/ live vaccines.