Fonkomustin 100mg powder for injection
Ferron Par Pharmaceuticals
Ingredients in every vial
|Bendamustine HCl monohydrate||100 mg|
Each package contains
|ATC Level 1||L - Antineoplastic and immunomodulating agents|
|ATC Level 2||L01 - Antineoplastic Agents|
|ATC Level 3||L01A - Alkylating Agents|
18 YEARS OLD AND ABOVE
100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; of 4 weeks cycles.
120 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; of 3 weeks cycles.
120-150 mg/m² body surface area bendamustine hydrochloride on days 1 and 2, combined with 60 mg/m² body surface area prednisone intravenous or per oral on days 1 to 4, of 4 weeks cycles.
There is no evidence that dose adjustments are necessary in elderly patients.
Intravenous infusion over 30 – 60 minutes. Infusion must be administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents.
PATIENTS WITH HEPATIC IMPAIRMENT
No dose adjustment is necessary in patients with mild hepatic impairment (serum bilirubin 3.0 mg/dl).
PATIENTS WITH RENAL IMPAIRMENT
No dose adjustment is necessary in patients with a creatinine clearance of >10 ml/minute. Experience in patients with severe renal impairment is limited.
Chronic Lymphocytic Leukemia (CLL) First-line treatment of chronic lymphocytic leukemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Non-Hodgkin Lymphoma (NHL) Indolent non-Hodgkin's lymphomas in patients, who have progressed following treatment with rituximab containing regimen. Multiple myeloma (MM) Treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) after failure to first line treatment 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.