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Bortezomib

BORTEXOMIB

Manufacturer: Dr.Reddy's Laboratories, Inc.

Score: 141.0

Quick Summary

Bortezomib is a proteasome inhibitor used for the treatment of adult patients with multiple myeloma and mantle cell lymphoma. It is administered intravenously or subcutaneously, with a recommended starting dose of 1.3 mg/m2. Bortezomib has shown efficacy in clinical trials, with common adverse reactions including nausea, diarrhea, thrombocytopenia, and peripheral neuropathy. Special population considerations include use during pregnancy, pediatric and geriatric use, and dose adjustments for patients with hepatic impairment.

Key Clinical Findings and Indications

  • Treatment of adult patients with multiple myeloma
  • Treatment of adult patients with mantle cell lymphoma
  • Efficacy in clinical trials for relapsed multiple myeloma and mantle cell lymphoma

Important Safety Information

Warning

Bortezomib can cause fetal harm when administered to a pregnant woman

Contraindications

  • Hypersensitivity to bortezomib, boron, or mannitol
  • Intrathecal administration

Adverse Reactions

  • Nausea
  • Diarrhea
  • Thrombocytopenia
  • Peripheral neuropathy

Dosing Recommendations

General Guidance

Dose reductions may be necessary for patients with hepatic impairment or peripheral neuropathy

Multiple myeloma

Adult Dose

1.3 mg/m2 administered intravenously or subcutaneously

Pediatric Dose

Not established

Mantle cell lymphoma

Adult Dose

1.3 mg/m2 administered intravenously

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Bortezomib can cause fetal harm
  • Use during pregnancy only if potential benefit justifies potential risk

Nursing Mothers

  • It is not known whether bortezomib is excreted in human milk
  • Caution should be exercised when administering bortezomib to nursing women

Pediatric Use

  • Safety and effectiveness have not been established in pediatric patients
  • Bortezomib has been evaluated in a single-arm multicenter trial in pediatric patients with lymphoid malignancies

Geriatric Use

  • No overall differences in safety or effectiveness were observed between patients ≥65 and younger patients
  • Greater sensitivity of some older individuals cannot be ruled out

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