Trade Names:Treanda- Injection, lyophilized powder for solution 100 mg
Inhibits cell proliferation. The exact mechanism is unknown.
C max occurs at the end of infusion.
Plasma protein binding ranges from 94% to 96%. Steady-state Vd is approximately 25 L.
Metabolized by hydrolysis to compounds with low cytotoxic activity.
Approximately 90% recovered in excreta, primarily in the feces. Intermediate half-life of the parent compound is 40 min.
Pharmacokinetics not different for patients with CrCl 40 to 80 mL/min. Pharmacokinetics in patients with CrCl less than 40 mL/min have not been studied.Hepatic Function Impairment
Mild hepatic function impairment has no effect on pharmacokinetics. Moderate to severe hepatic function impairment has not been studied.Elderly
No difference in pharmacokinetics between patients 65 yr of age and older and younger patients.Gender
No difference in pharmacokinetics between men and women.Race
Safety and efficacy not established based on race; however, exposure to the drug was 40% higher in Japanese subjects than in non-Japanese subjects.
Treatment of chronic lymphocytic leukemia; treatment of indolent B-cell non-Hodgkin lymphoma that has progressed during or within 6 mo of treatment with rituximab or a rituximab-containing regimen.
Hypersensitivity to mannitol or any component of the product.
IV 100 mg/m 2 infused over 30 min on days 1 and 2 of a 28-day cycle for up to 6 cycles.Dose Modifications Delays
Delay therapy in the event of grade 4 hematologic toxicity or grade 2 or higher nonhematologic toxicity. Once nonhematologic toxicity has recovered to grade 1 or less and/or blood cell counts have improved (absolute neutrophil count [ANC] at least 1 × 10 9 /L, platelets at least 75 × 10 9 /L), therapy can be reinstated.Modification
For grade 3 or higher hematologic toxicity, reduce dose to 50 mg/m 2 on days 1 and 2 of each cycle. If grade 3 or higher toxicity recurs, reduce dose to 25 mg/m 2 on days 1 and 2 of each cycle. For grade 3 or higher nonhematologic toxicity, reduce dose to 50 mg/m 2 on days 1 and 2 of each cycle.Dose reinitiation
Re-escalation of dose in subsequent cycles may be considered at the discretion of the treating health care provider.Non-Hodgkin LymphomaAdults
IV 120 mg/m 2 infused over 60 min on days 1 and 2 of a 21-day cycle, up to 8 cycles.Dose Modifications Delays
IV Delay therapy in the event of grade 4 hematologic toxicity or grade 2 or higher nonhematologic toxicity. Once nonhematologic toxicity has recovered to grade 1 or less and/or blood cell counts have improved (ANC at least 1 x 10 9 /L, platelets at least 75 x 10 9 /L), therapy can be reinstated.Modifications
IV For grade 4 hematologic toxicity, reduce the dose to 90 mg/m 2 on days 1 and 2 of each cycle. If grade 4 toxicity recurs, reduce dose to 60 mg/m 2 on days 1 and 2 of each cycle. For grade 3 or higher nonhematologic toxicity, reduce dose to 90 mg/m 2 on days 1 or 2 of each cycle. If grade 3 or higher toxicity recurs, reduce dose to 60 mg/m 2 on days 1 and 2 of each cycle.
Store at 77° to 86°F. Protect from light. Once diluted, the final admixture is stable for 24 h when stored under refrigeration at 36° to 47°F or for 3 h when stored at 59° to 86°F in room light. Administration should be completed within this time period.
May decrease bendamustine plasma concentrations and increase levels of its active metabolites.Inhibitors of CYP1A2 (eg, ciprofloxacin, fluvoxamine)
May increase bendamustine plasma concentrations and decrease levels of its active metabolites.
None well documented.
Tachycardia (7%); hypotension (6%).
Fatigue (57%); anorexia (23%); headache (21%); dizziness (14%); decreased appetite, insomnia (13%); asthenia (11%); anxiety (8%); dysgeusia (7%); depression (6%).
Rash (16%); pruritus (6%); dry skin, hyperhidrosis, night sweats (5%).
Pharyngolaryngeal pain (8%); nasopharyngitis (7%); nasal congestion (5%).
Nausea (75%); vomiting (40%); diarrhea (37%); constipation (29%); stomatitis (15%); abdominal pain (13%); dyspepsia (11%); gastroesophageal reflux disease (10%); dry mouth (9%); oral candidiasis (6%); abdominal distension, upper abdominal pain (5%).
Febrile neutropenia (6%).
Hypersensitivity (5%); anaphylaxis (postmarketing).
Decreased lymphocytes (99%); decreased leukocytes (94%); decreased hemoglobin (89%); decreased neutrophils, decreased platelets (86%); increased bilirubin (34%); elevated creatinine (2%).
Infusion-site pain (6%); catheter-site pain (5%); injection-site irritation, pain, pruritus, and swelling (postmarketing).
Decreased weight (18%); dehydration (14%); hypokalemia (9%); hyperuricemia (7%); hypocalcemia, hyponatremia (2%).
Back pain (14%); arthralgia (6%); bone pain, pain in extremities (5%).
Cough (22%); dyspnea (16%); upper respiratory tract infection (10%); sinusitis (9%); pneumonia (8%); wheezing (5%).
Pyrexia (34%); chills (14%); peripheral edema (13%); herpes zoster (10%); chest pain, infection, pain (6%); herpes simplex (3%).
Category D .
Safety and efficacy not established.
No differences in the adverse reaction profile in patients 65 yr of age and older compared with younger patients.
Do not use in patients with CrCl less than 40 mL/min.
Use with caution in patients with mild hepatic function impairment. Avoid use in patients with moderate to severe hepatic function impairment.
Anaphylaxis and anaphylactoid reactions have been reported, especially in the second and subsequent cycles of therapy.
Infections, including pneumonia and sepsis, have been reported. Patients experiencing myelosuppression after treatment are more susceptible to infections.
Were reported frequently in clinical trials.
Premalignant and malignant diseases, including acute myeloid leukemia and bronchial carcinoma, myelodysplastic syndrome, and myeloproliferative disorders, have been reported.
Likely to occur.
Have been reported and may include bullous exanthema, toxic skin reactions, and rash. If reactions are severe or progressive, withhold or discontinue treatment.
Has been reported, and the onset tends to be within the first treatment cycle. Without intervention, acute renal failure and death may occur. Consider using allopurinol as prevention for patients at high risk of tumor lysis syndrome.
ECG changes, including QT prolongation, sinus tachycardia, ST- and T-wave deviations, and left anterior fascicular block.
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