Bendared Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Bendamustine HCl

Indications/Uses

Monotherapy in patients w/ chronic lymphocytic leukaemia; indolent B-cell non-Hodgkin's lymphomas that has progressed during or w/in 6 mth of rituximab or rituximab-containing treatment regimen.

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Dosage/Direction for Use

Monotherapy for chronic lymphocytic leukaemia 100 mg/m² IV infusion over 30-60 min on days 1 & 2 every 4 wk. Monotherapy for indolent non-Hodgkin's lymphomas refractory to rituximab 120 mg/m² IV infusion over 30-60 min on days 1 & 2 every 3 wk. Moderate hepatic impairment Reduce dose to 30%.

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Overdosage

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Contraindications

Hypersensitivity. Severe bone marrow suppression & blood count alterations (leukocyte &/or platelet values dropped to <3,000/microliter or <75,000/microliter, respectively). Infections especially leukocytopenia. Yellow fever vaccination. Major surgery <30 days prior to treatment. Jaundice; severe hepatic impairment (serum bilirubin >3 mg/dL). Lactation.

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Special Precautions

Discontinue use if severe skin reactions occur; signs of opportunistic infections are present. Severe anaphylactic & anaphylactoid reactions. Myelosuppression; concurrent or history of cardiac disease; nausea, vomiting; tumor lysis syndrome. Test for HBV infection prior to initiation. Closely monitor blood chemistry particularly K & uric acid levels prior to therapy. Ensure adequate hydration. Avoid extravasation. May affect ability to drive & use machines. Moderate hepatic & severe renal impairment. May cause irreversible infertility. Women of childbearing potential should use effective contraception. Male patients should use effective contraception during & up to 6 mth after last dose. Not to be used during pregnancy & lactation. Ped patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Infection; leukopenia, thrombocytopenia, lymphopenia; headache; nausea, vomiting; mucosal inflammation, fatigue, pyrexia; decreased Hb, increased creatinine & urea. Tumor lysis syndrome; haemorrhage, anaemia, neutropenia; hypersensitivity; insomnia, dizziness; arrhythmia, cardiac dysfunction eg, palpitations, angina pectoris; hypotension, HTN; pulmonary dysfunction; diarrhoea, constipation, stomatitis; alopecia, skin disorders, urticaria; amenorrhea; pain, chills, dehydration, anorexia; increased AST, ALT, alkaline phosphatase & bilirubin, hypokalemia.

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Drug Interactions

Potentiated effect w/ myelosuppressive agents. Excessive immunosuppression w/ risk of lymphoproliferation w/ cyclosporine or tacrolimus. Reduced Ab formation & increased risk of infection by cytostatics. Concomitant use w/ CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin, acyclovir, cimetidine.

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Caution For Usage

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Storage

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Description

View Bendared description for details of the chemical structure and excipients (inactive components).

Action

View Bendared mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01AA09 - bendamustine ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Bendared infusion conc 180 mg/4 mL

Packing/Price

1's

Bendared

bendamustine

Manufacturer:

Dr. Reddy's Lab

Distributor:

DKSH