Fonkomustin 100

Indonesia • Ferron Par Pharmaceuticals

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’s 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.

Composition

Bendamustine HCl monohydrate 100 mg

Package

1 vial of 100 mg

Dosage Forms

Powder for Injection

ATC Classification

L01A

Warning

Alcohol
Consult Your Doctor
Safety of this item for use with alcohol has not been established. Please consult your doctor.
Machinery
Caution
This item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.
Pregnancy
Not Recommended
This item is not safe for use during pregnancy.
Lactation
Not Recommended
This item is not safe for use during lactation.

Dosage

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.

Elderly Patients

There is no evidence that dose adjustments are necessary in elderly patients.

Other Details

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.