Ribomustin

Ribomustin

bendamustine

Manufacturer:

Johnson & Johnson
Concise Prescribing Info
Contents
Bendamustine HCl
Indications/Uses
1st-line treatment of chronic lymphocytic leukemia (CLL) (Binet Stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. Indolent non-Hodgkin’s lymphoma (iNHL), in patients who have progressed following treatment w/ rituximab containing regimen. Multiple myeloma/MM (Durie-Salmon stage II w/ progress or stage III) after failure to 1st-line treatment in combination w/ prednisone for patients >65 yr who are not eligible for autologous stem-cell transplantation & who have clinical neuropathy at time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.
Dosage/Direction for Use
For IV infusion over 30-60 min. CLL 100 mg/m2 on days 1 & 2 of 4 wk cycles. iNHL 120 mg/m2 on days 1 & 2 of 3 wk cycles. MM 120-150 mg/m2 on days 1 & 2, combined w/ 60 mg/m2 prednisone IV or per os on days 1-4 of 4 wk cycle.
Contraindications
Hypersensitivity. Jaundice; severe bone marrow suppression & severe blood count alterations; major surgery <30 days prior start of treatment; infections, especially involving leukocytopenia; yellow fever vaccination. Severe hepatic impairment. Lactation.
Special Precautions
Should not be used during severe bone marrow suppression & severe blood count alterations. Monitor for resp signs & symptoms throughout treatment. Monitor leukocytes, platelets, Hb & neutrophils wkly. Consider discontinuation if there are signs of opportunistic infections. Patients w/ skin reactions; concurrent or history of cardiac disease. Tumor lysis syndrome; anaphylaxis; secondary tumors eg, myelodysplastic syndrome; myeloproliferative disorders, acute myeloid leukemia & bronchial carcinoma. Stop extravasal inj immediately. Test patients for HBV infection prior to initiation of treatment. May impair ability to drive & use machines. Women should not become pregnant during treatment & must use effective methods of contraception both before & during therapy. Male patients should not father a child during & up to 6 mth after treatment. May cause irreversible male infertility. Childn & adolescents.
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
Potentiation of effects w/ myelosuppressive agents. Excessive immunosuppression & risk of lymphoproliferation w/ cyclosporine or tacrolimus. Increased risk of infection w/ cytostatics. CYP1A2 inhibitors eg, fluvoxamine, ciprofloxacin, acyclovir, cimetidine.
ATC Classification
L01AA09 - bendamustine ; Belongs to the class of alkylating agents, nitrogen mustard analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Ribomustin powd for infusion 100 mg
Packing/Price
1's (Rp4,612,426/boks)
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