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Bortezomib

BORTEZOMIB

Manufacturer: Hospira, 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 dosing regimens varying based on the specific condition being treated and patient factors. Key clinical findings indicate efficacy in achieving response and improving time to progression in relapsed multiple myeloma and previously untreated mantle cell lymphoma. Important safety information includes warnings about peripheral neuropathy, hypotension, cardiac toxicity, and pulmonary toxicity, among others. Contraindications include hypersensitivity to bortezomib, boron, or mannitol, and intrathecal administration. Dosing recommendations are provided for different conditions, with considerations for dose adjustments based on toxicity and special populations such as pregnancy, nursing mothers, pediatric, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of adult patients with multiple myeloma
  • Treatment of adult patients with mantle cell lymphoma
  • Efficacy in achieving response and improving time to progression in relapsed multiple myeloma
  • Efficacy in previously untreated mantle cell lymphoma

Important Safety Information

Warning

Peripheral neuropathy, hypotension, cardiac toxicity, and pulmonary toxicity are potential adverse reactions

Contraindications

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

Adverse Reactions

  • Peripheral neuropathy
  • Hypotension
  • Cardiac toxicity
  • Pulmonary toxicity
  • Thrombocytopenia
  • Neutropenia
  • Anemia
  • Fatigue
  • Nausea
  • Diarrhea
  • Constipation

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on toxicity, with reductions to 1 mg/m^2 or 0.7 mg/m^2

Multiple myeloma

Adult Dose

1.3 mg/m^2 administered intravenously or subcutaneously twice weekly for 2 weeks, followed by a 10-day rest period

Pediatric Dose

Not established

Mantle cell lymphoma

Adult Dose

1.3 mg/m^2 administered intravenously or subcutaneously twice weekly for 2 weeks, followed by a 10-day rest period

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Bortezomib can cause fetal harm when administered to a pregnant woman
  • Advise pregnant women of the potential risk to the fetus

Nursing Mothers

  • Advise nursing women not to breastfeed during treatment with bortezomib and for 2 months after treatment

Pediatric Use

  • Safety and effectiveness have not been established in pediatric patients

Geriatric Use

  • No overall differences in safety or effectiveness were observed between patients ≥65 and younger patients receiving bortezomib