Bendamustine 100 mg. Injectable lyophilized powder.
ESEVARIL® 100 mg. Individual package containing a single-use vial.
First-line treatment of Chronic Lymphocytic Leukaemia (Binet stage B or C) in patients for whom Fludarabine combination chemotherapy is not appropriate. Indolent Non-Hodgkin's Lymphoma: as monotherapy in patients who have progressed during or within 6 months following treatment with Rituximab or a Rituximab containing regimen. Front line treatment of Multiple Myeloma (Durie-Salmon stage II with progress or stage III) in combination with Prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at time of diagnosis precluding the use of Thalidomide or Bortezomib containing treatment.
Dosage and administration:
Chronic Lymphocytic Leukemia: 100 mg/m2 infused intravenously over 30 minutes on days 1 and 2, each 4 weeks. Indolent Non-Hodgkin's Lymphoma: 120 mg/m2 infused intravenously over 60 minutes on days 1 and 2, each 3 weeks. Multiple Myeloma: 120 - 150 mg/m2 infused intravenously on days 1 and 2, plus Prednisone orally or intravenously, days 1 to 4, each 4 weeks.
After reconstitution and dilution, store at 3,5 hours up to 25°C, and for 2 days between 2ºC and 8ºC in infusion bags. The administration of ESEVARIL® must be completed within this period.