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Fonkomustin 25mg powder for injection

Ferron Par Pharmaceuticals

Ingredients in every vial

Bendamustine HCl monohydrate 25 mg

Each package contains

1 vial of 25 mg

Dosage form

Powder for injection

Dosage formPowder for injection

Flavour

None

W.H.O. classification

L01A
L01A

A.T.C. Level 1

Anatomical Main group

L - Antineoplastic and immunomodulating agents
L01A

A.T.C. Level 2

Therapeutic subgroup

L01 - Antineoplastic Agents
L01A

A.T.C. Level 3

Pharmacological subgroup

L01A - Alkylating Agents

Available in

Indonesia

Warnings

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 and after consultation with your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

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.

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.