Fonkomustin 100mg powder for injection
Ferron Par Pharmaceuticals
Ingredients in every vial
| Bendamustine HCl monohydrate | 100 mg |
Each package contains
1 vial of 100 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.
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.
— 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.