Package:
VIALS (concentrate for solution for infusion): 2 x 100 mg/10 ml; 1 x 500 mg/50 ml. Dosage: Non-Hodgkin's lymphoma (NHL):
Low grade and/or follicular B-cell non-Hodgkin's lymphoma: Use as a single agent for adult patients: 375 mg/m2 body surface, I.V. infusion once weekly for 4 weeks.
Diffuse large B-cell non-Hodgkin's lymphoma: Use in combination with CHOP chemotherapy. The recommended dosage is 375 mg/m2 body surface, administered on day 1 of each chemotherapy cycle for 8 cycles after IV administration of the corticosteroid component of CHOP.
Safety and efficacy have not been established in combination with other chemotherapies.
Rheumatoid arthritis: 1,000 mg by I.V. infusion followed by a second 1,000 mg I.V. infusion two weeks later.
Previously untreated follicular lymphoma: 375 mg/m2 body surface area once every 2 months (starting 2 months after the last dose of induction therapy) until disease progression or for a maximum period of two years.
Maintenace therapy for relapsed/refractory follicular lymphoma: 375 mg/m2 body surface once every 3 months (starting 3 months after the last dose of induction therapy) until disease progression or for a maximum period of two years. Chronic lymphocytic leukemia (CLL): 375 mg/m2 on day 1 of the first treatment cycle, followed by 500 mg/m2 on day 1 of each subsequent cycle for 6 cycles in total. See prescribing information for full details. Prescribing Restrictions:
Indications:
Non-Hodgkin's lymphoma (NHL): Treatment of relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma. Treatment of previously untreated patients with low grade or follicular lymphoma in combination with chemotherapy. Treatment of patients with CD2O positive diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP chemotherapy. Maintenance therapy for the treatment of follicular lymphoma patients responding to induction therapy.
Chronic lymphocytic leukemia (CLL): In combination with chemotherapy for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies, or patients refractory to previous MabThera plus chemotherapy. Contra-Indications:
Known hypersensitivity to any component or to murine proteins. See prescribing information for full details. Special Precautions:
Should be administered in a hospital environment where full resuscitation facilities are immediately available. Patients with a high number (> 25,000 mm3) of circulating malignant cells or high tumour burden, who may be at higher risk of especially severe cytokine release syndrome, should only be treated with extreme caution and when other therapeutic alternatives have been exhausted. Women of childbearing potential should use effective contraceptive methods during treatment and up to 12 months following therapy. See prescribing information for full details. Side Effects:
Cytokine release syndrome occurred in more than 50% of patients, predominantly seen during the first infusion, usually during the first one to two hours. These events mainly comprised fever, chills, and rigors. Flushing, angioedema, nausea, urticaria/rash, fatigue, headache, throat irritation, rhinitis, vomiting, and tumour pain, accompanied by hypotension and bronchospasm in about 10% of the cases. Severe bronchoconstriction. Anaphylaxis. See prescribing information for full details. Drug Interactions:
Currently, no data are available on possible drug interactions. Patients with human anti-mouse or human anti-chimeric antibody (HAMA/HACA) titres may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies. The tolerability of simultaneously or sequential combination with chemotherapy other than CHOP or CVP or agents which are liable to cause depletion of normal B-cells is not well defined. See prescribing information for full details.
