Administration
MabThera should be administered as an intravenous (i.v.) infusion through a dedicated line.1 The prepared infusion solutions should not be administered as an i.v. push or bolus.
Pre-medication consisting of paracetamol and diphenhydramine should always be administered before each infusion of MabThera.1 Pre-medication with corticosteroid should also be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
The recommended initial infusion rate for MabThera is 50mg/h. After the first 30 minutes, the rate can then be increased by 50mg/h every 30 minutes to a maximum of 400mg/h.1 Subsequent infusions of MabThera can be started at a rate of 100mg/h and increased by 100mg/h every 30 minutes to a maximum of 400mg/h.
No dose reductions are recommended for MabThera. When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic agents should be applied.
Follicular non-Hodgkin's lymphoma (NHL)
Combination therapy
The recommended dose of MabThera in combination with chemotherapy for induction treatment of previously untreated or relapsed/refractory patients with follicular NHL (FL) is 375mg/m2 per cycle, for up to 8 cycles.
MabThera should be administered on day 1 of each chemotherapy cycle, after i.v. administration of the glucocorticoid component of the chemotherapy (if applicable).
Monotherapy, induction and maintenance
The recommended dose of MabThera used as maintenance treatment for patients with relapsed/refractory FL who have responded to induction treatment with chemotherapy (with or without MabThera) is 375mg/m2, administered as an i.v. infusion once every 3 months until disease progression for a maximum period of 2 years.
The recommended dose of MabThera monotherapy used as induction treatment for adult patients with stage III–IV FL who are chemoresistant or are in their second or subsequent relapse after chemotherapy is 375mg/m2, administered as an i.v. infusion once weekly for 4 weeks.
For retreatment with MabThera monotherapy in patients with relapsed/refractory FL who previously responded to MabThera monotherapy, the recommended dose is 375mg/m2, administered as an i.v. infusion once weekly for 4 weeks.
Diffuse large B cell non-Hodgkin's lymphoma
MabThera should be used in combination with cyclophosphamide, vincristine, prednisone and doxorubicin (CHOP) chemotherapy. The recommended dosage is 375mg/m2 on day 1 of each chemotherapy cycle (after i.v. infusion of the glucocorticoid component of CHOP) for a total of 8 cycles.
Chronic lymphocytic leukaemia (CLL)
Prophylaxis consisting of adequate hydration and administration of uricostatics starting 48 hours prior to start of therapy is recommended for CLL patients to reduce the risk of tumour lysis syndrome. For patients whose lymphocyte counts are >25 x 109/L, 100mg prednisone/prednisolone should be given i.v. shortly before MabThera infusion to decrease the rate and severity of acute infusion reactions and/or cytokine release syndrome.
The recommended dosage of MabThera in combination with chemotherapy is 375mg/m2 on day 1 of the first treatment cycle followed by 500mg/m2 on day 1 of each subsequent cycle for 6 cycles in total. The chemotherapy should be given after MabThera infusion.
Reference
1. MabThera Summary of Product Characteristics.
