Fonkomustin 100mg powder

Ferron Par Pharmaceuticals

Ingredients in every vial

Bendamustine HCl monohydrate 100 mg

Each package contains

1 vial of 100 mg

Other details

Dosage form:Powder for injection
Flavour: None

W.H.O. classification

ATC Level 1: L - Antineoplastic and immunomodulating agents
ATC Level 2: L01 - Antineoplastic Agents
ATC Level 3: L01A - Alkylating Agents

Warnings

Pregnancy

NOT SAFEThis item is not safe for use during pregnancy.

Lactation

NOT SAFEThis item is not safe for use during lactation.

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution.

Available in

Indonesia

Dosage information

18 YEARS OLD AND ABOVE
CLL: 100 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; of 4 weeks cycles.
NHL: 120 mg/m² body surface area bendamustine hydrochloride on days 1 and 2; of 3 weeks cycles.
MM: 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.

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.

65 YEARS OLD AND ABOVE
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.

OTHER DETAILS
HEPATIC IMPAIRMENT
No dose adjustment is necessary in patients with mild hepatic impairment (serum bilirubin 3.0 mg/dl).

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.

Indication

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.

Disclaimer

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