MabThera monotherapy is indicated for treatment of patients with stage III-IV Follicular Lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
Follicular Lymphoma (FL)
CD20 monoclonal antibody
1. Approved Labelling
MabThera monotherapy is indicated for treatment of patients with stage III-IV Follicular Lymphoma (FL) who are chemoresistant or are in their second or subsequent relapse after chemotherapy.
2. Treatment Regimen
MabThera should be administered under the close supervision of an experienced healthcare professional, and in an environment where full resuscitation facilities are immediately available.
Premedication consisting of an anti-pyretic and an antihistaminic, e.g. paracetamol and diphenhydramine, should always be given before each administration of MabThera.
In patients with Non-Hodgkin’s Lymphoma, premedication with glucocorticoids should be considered if MabThera is not given in combination with glucocorticoid-containing chemotherapy.
The recommended dose of MabThera in combination with chemotherapy for induction treatment of Relapsed/Refractory (RR) patients with FL is: 375 mg/m2 body surface area per cycle, for up to 8 cycles.
MabThera should be administered on day 1 of each chemotherapy cycle, after intravenous administration of the glucocorticoid component of the chemotherapy if applicable.
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: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
For retreatment with MabThera monotherapy for patients who have responded to previous treatment with MabThera monotherapy for R/R Follicular Lymphoma, the recommended dose is: 375 mg/m2 body surface area, administered as an intravenous infusion once weekly for four weeks.
No dose reductions of MabThera are recommended. When MabThera is given in combination with chemotherapy, standard dose reductions for the chemotherapeutic medicinal products should be applied
The prepared MabThera solution should be administered as an intravenous infusion through a dedicated line. It should not be administered as an intravenous push or bolus.
Patients should be closely monitored for the onset of cytokine release syndrome. Patients who develop evidence of severe reactions, especially severe dyspnoea, bronchospasm or hypoxia should have the infusion interrupted immediately.
In all patients, the infusion should not be restarted until complete resolution of all symptoms, and normalisation of laboratory values and chest X-ray findings. At this time, the infusion can be initially resumed at not more than one-half the previous rate. If the same severe adverse reactions occur for a second time, the decision to stop the treatment should be seriously considered on a case by case basis.
Mild or moderate infusion-related reactions (IRR) usually respond to a reduction in the rate of infusion. The infusion rate may be increased upon improvement of symptoms.
The recommended initial rate for infusion is 50 mg/h; after the first 30 minutes, it can be escalated in 50 mg/h increments every 30 minutes, to a maximum of 400 mg/h.
Subsequent doses of MabThera can be infused at an initial rate of 100 mg/h, and increased by 100 mg/h increments at 30 minute intervals, to a maximum of 400 mg/h.
Please see section 4.4 of the SmPC.
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