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Safety

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Velcade (bortezomib) for Injection


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Use in Pregnancy
  • Peripheral Neuropathy
  • Cardiac Disorders
  • Gastrointestinal Adverse Events
  • Thrombocytopenia/Neutropenia
    • Table 4

ADVERSE REACTIONS

  • Clinical Trials Safety Experience
    • Summary of Clinical Trial in Patients with Previously Untreated Multiple Myeloma (new subsection)
      • Table 5 (new)
    • Description of Selected Adverse Events from the Phase 2 and 3 Relapsed Multiple Myeloma and Phase 2 Mantle Cell Lymphoma Studies
      • Herpes Virus Infection

DRUG INTERACTIONS

  • Ketoconazole
  • Melphalan-Prednisone
  • Omeprazole

USE IN SPECIFIC POPULATIONS

  • Pregnancy
  • Patients with Renal Impairment

PATIENT COUNSELING INFORMATION

  • Dehydration/Hypotension
  • Pregnancy/Nursing
  • Concomitant Medications
  • Diabetic Patients
  • Peripheral Neuropathy
  • Other

WARNINGS AND PRECAUTIONS

Use in Pregnancy

...Bortezomib administered to rabbits during organogenesis caused post-implantation loss and a decreased number of live fetuses...

Peripheral Neuropathy

...Following dose adjustments, improvement in or resolution of peripheral neuropathy was reported in 51% of patients with >Grade 2 peripheral neuropathy in the relapsed multiple myeloma study...

Cardiac Disorders

...In the relapsed multiple myeloma study, the incidence of any treatment-emergent cardiac disorder was 15% and 13% in the Velcade and dexamethasone groups, respectively...

Gastrointestinal Adverse Events

...Ileus can occur...

Thrombocytopenia/Neutropenia

Velcade is associated with thrombocytopenia and neutropenia that follow a cyclical pattern with nadirs occurring following the last dose of each cycle and typically recovering prior to initiation of the subsequent cycle...

...In the relapsed multiple myeloma study, the incidence of significant bleeding events (>Grade 3) was similar on both the Velcade (4%) and dexamethasone (5%) arms. Platelet count should be monitored prior to each dose of Velcade. Patients experiencing thrombocytopenia may require change in the dose and schedule of Velcade...
    
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