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Safety and tolerability were evaluated in more than 700 patients with relapsed or relapsed and refractory multiple myeloma1,2

In PANORAMA 1, the types of adverse events (AEs) observed with FVD regimen were consistent with prior experience with bortezomib (BTZ)/dexamethasone (dex) treatment alone1

Diarrhoea, fatigue, nausea, and vomiting were the most common nonhaematological events. Treatment-emergent haematological toxicities included thrombocytopenia, anaemia, neutropenia, and lymphopenia.

References:

  1. Data on file. FARYDAK (panobinostat) core data sheet version 1.0. Novartis Pharmaceuticals Corp; May 2014.
  2. FARYDAK® (panobinostat). EU Summary of Product Characteristics. Novartis AG; August 2015.
  3. San-Miguel J, Hungria VTM, Yoon S, et al. Efficacy and safety based on duration of treatment of panobinostat plus bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma in the phase 3 Panorama 1 study. Presented at: 56th ASH Annual Meeting and Exposition; December 6-9, 2014; San Francisco, CA.
  4. Data on file. Clinically notable adverse events regardless of study drug relationship by treatment group (safety set)-by treatment phase for patients who completed treatment phase 2. July 2014.
  5. Data on file. Clinically notable grade 3/4 adverse events regardless of study drug relationship by treatment group (safety set)-by treatment phase for patients who completed treatment phase 2. July 2014.
  6. Data on file. PANORAMA 1: AE analysis. July 2014.

Need more information on AEs? See discontinuation rates