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Bendamustine

BENDAMUSTINE HCL

Manufacturer: Meitheal Pharmaceuticals Inc.

Score: 141.0

Quick Summary

Bendamustine hydrochloride is an alkylating agent used for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The recommended dose is 100 mg/m^2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles for CLL, and 120 mg/m^2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles for NHL. Bendamustine hydrochloride is contraindicated in patients with a known hypersensitivity to bendamustine. The most common adverse reactions are myelosuppression, infections, nausea, vomiting, diarrhea, fatigue, pyrexia, and anemia.

Key Clinical Findings and Indications

  • Treatment of chronic lymphocytic leukemia (CLL)
  • Treatment of indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen

Important Safety Information

Warning

Bendamustine hydrochloride is contraindicated in patients with a known hypersensitivity to bendamustine.

Contraindications

  • Known hypersensitivity to bendamustine

Adverse Reactions

  • Myelosuppression
  • Infections
  • Nausea
  • Vomiting
  • Diarrhea
  • Fatigue
  • Pyrexia
  • Anemia

Dosing Recommendations

General Guidance

Dose delays, dose modifications, and reinitiation of therapy may be necessary based on hematologic and non-hematologic toxicity.

CLL

Adult Dose

100 mg/m^2 administered intravenously over 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles

Pediatric Dose

NHL

Adult Dose

120 mg/m^2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles

Pediatric Dose

Special Population Considerations

Pregnancy

  • Bendamustine hydrochloride may cause fetal harm when administered to a pregnant woman.

Nursing Mothers

  • It is not known whether bendamustine hydrochloride is excreted in human milk.

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

  • No overall differences in safety were observed between patients ≥65 years of age and younger patients.