Ribomustin 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 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 w/ rituximab or rituximab-containing 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.

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Overdosage

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Contraindications

Hypersensitivity. Jaundice; severe bone marrow suppression & severe 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. Severe hepatic impairment (serum bilirubin >3 mg/dL). Lactation.

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Special Precautions

Myelosuppression, do not use during severe bone marrow suppression & severe blood count alterations. Infections, discontinue if there are signs of (opportunistic) infections. Skin reactions, discontinue use if severe skin reactions occur. Patients w/ cardiac disorders, monitor closely for patients w/ concurrent or history of cardiac disease. Nausea, vomiting, give antiemetic. Tumor lysis syndrome. Anaphylaxis. Extravastation. Non-melanoma skin cancer, periodic skin exam. Hepatitis B reactivation, test for HBV infection before initiating treatment. May affect ability to drive & use machines. Moderate hepatic & severe renal impairment. Contraception, Women should not become pregnant during treatment. Male patients should not father a child during & up to 6 mth after treatment. 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; nausea, vomiting; mucosal inflammation, fatigue, pyrexia; decreased Hb, increased creatinine & urea. Tumor lysis syndrome; hemorrhage, anemia, neutropenia; hypersensitivity; insomnia; cardiac dysfunction, atrial fibrillation; hypotension; pulmonary dysfunction; diarrhea, constipation, stomatitis; alopecia, skin disorders; amenorrhea; pain, chills, dehydration, anorexia; increased AST, ALT, alkaline phosphatase & bilirubin, hypokalemia.

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Drug Interactions

Increased toxicity w/ myelosuppresive agents. Excessive immunosuppression w/ risk of lymphoproliferation w/ cyclosporine or tacrolimus. Reduced Ab formation & increased risk of infection by cytostatics. 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 Ribomustin description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

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

Presentation/Packing

Form

Ribomustin infusion conc (vial) 100 mg

Packing/Price

1's

Form

Ribomustin infusion conc (vial) 25 mg

Packing/Price

1's

Ribomustin

bendamustine

Manufacturer:

Janssen

Distributor:

Zuellig Pharma