Bendamax 25mg/vial

Bendamax 25mg/vial

Generic: Bendamustine

Manufacturer

Beacon Pharmaceuticals PLC

৳ 1,200

Precautions & Warnings

Mild to moderate hepatic and renal impairment. Pregnancy and lactation.

Use in Special Populations

Hepatic Impairment: Moderate: Reduce dose by 30%.

Overdose Effects

Symptoms: Cardiotoxicity, thrombocytopenia.

Management: May perform bone marrow transplantation and transfusions to control haematological effects. It is dialysable to a small extent.

Therapeutic Class

Cytotoxic Chemotherapy

Reconstitution

Reconstitute powder for inj by adding 5 ml or 20 ml of sterile water for inj to a vial containing 25 mg or 100 mg, respectively to provide a soln containing 5 mg/ml. The lyophilised powder should be dissolved w/in 5 min, shake well to facilitate dissolution. within 30 min of reconstitution, the appropriate volume should be withdrawn from the vial to further dilute in 500 ml of either NaCl 0.9% inj or dextrose 2.5% and NaCl 0.45% inj to a final concentration of 0.2-0.6 mg/ml.

Storage Conditions

Store below 25° C, prior to reconstitution. Protect from light.

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Description

Indications

Chronic Lymphocytic Leukemia (CLL): Bendamax is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established.

Non-Hodgkin Lymphoma (NHL): Bendamaxis indicated for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Also indicated in Multiple myeloma.

Pharmacology

Bendamustine is a bifunctional mechlorethamine derivative capable of forming electrophilic alkyl groups that covalently bond to other molecules. Through this function as an alkylating agent, bendamustine causes intra- and inter-strand crosslinks between DNA bases resulting in cell death. It is active against both active and quiescent cells, although the exact mechanism of action is unknown.

Dosage & Administration

Chronic lymphocytic leukaemia: 100 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle for up to 6 cycles. For severe haematological or non-haematological toxicity: Reduce dose to 50 mg/m2 on days 1 and 2 of each cycle. If severe haematological toxicity recurs, further reduce dose to 25 mg/m2 on days 1 and 2 of each cycle. May consider dose re-escalation in subsequent cycles.

Multiple myeloma: 120-150 mg/m2 infused over 30-60 min on days 1 and 2 of a 28-day cycle. IV or oral prednisone may be given at a dose of 60 mg/m2 on days 1-4 of the cycle.

Non-Hodgkin’s lymphoma: 120 mg/m2 infused over 30-60 min on days 1 and 2 of a 21-day cycle for up to 8 cycles. For severe haematological or non-haematological toxicity: Reduced to 90 mg/m2 on days 1 and 2 of each cycle. If severe toxicity recurs, further reduce dose to 60 mg/m2 on days 1 and 2 of each cycle.

Interaction

May increase plasma levels with CYP1A2 inhibitors (e.g. ciprofloxacin, fluvoxamine). May reduce plasma levels with CYP1A2 inducers (e.g. omeprazole and tobacco smoking).

Contraindications

Patient with history of hypersensitivity (e.g. anaphylaxis and anaphylactoid reactions); jaundice, severe bone marrow suppression, low leukocyte or platelet count. Severe hepatic impairment. Major surgery <30 days prior to treatment.

Side Effects

Malignant and pre-malignant disease; pyrexia, nausea, vomiting, cough, headache, fatigue, diarrhoea, constipation, anorexia, wt decrease, rash, stomatitis, lymphopenia, anaemia, thrombocytopenia, leucopenia, neutropenia.

Pregnancy & Lactation

Pregnancy category D. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

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