Ribomustin

Ribomustin

bendamustine

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
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.
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.
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.
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, preventive measures include adequate vol status, close monitoring of blood chemistry. Anaphylaxis. Extravasation, stop immediately, needle should be removed after short aspiration, affected area of tissue should be cold, arm should be elevated. 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.
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 eg, palpitations, angina pectoris, atrial fibrillation; hypotension; pulmonary dysfunction; diarrhea, constipation, stomatitis; alopecia, skin disorders; amenorrhea; pain, chills, dehydration, anorexia; increased AST, ALT, alkaline phosphatase & bilirubin, hypokalemia.
Drug Interactions
Potentiated effect 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.
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
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