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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.

  • On-treatment deaths, regardless of causality, were reported in 6.8% of patients treated with FVD regimen vs 3.2% of patients treated with placebo/BTZ/dex. The most frequent treatment-related causes of death included infections and haemorrhage2
  • Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation, and sinus tachycardia) were reported in 17.6% of FVD-treated patients vs 9.8% of placebo/BTZ/dex-treated patients and syncope events were reported in 6.0% vs 2.4%, respectively2
  • Hypothyroidism events were reported in 8 of 381 patients treated with FVD regimen, of whom 2 required treatment2

Please refer to your country label for more information.

ALT=alanine transaminase.
AST=aspartate transaminase.
SGOT=serum glutamic oxaloacetic transaminase.
SGPT=serum glutamic pyruvic transaminase.

  • On-treatment deaths, regardless of causality, were reported in 6.8% of patients treated with FVD regimen vs 3.2% of patients treated with placebo/BTZ/dex. The most frequent treatment-related causes of death included infections and haemorrhage2
  • Cardiac events (most frequently atrial fibrillation, tachycardia, palpitation, and sinus tachycardia) were reported in 17.6% of FVD-treated patients vs 9.8% of placebo/BTZ/dex-treated patients and syncope events were reported in 6.0% vs 2.4%, respectively2
  • Hypothyroidism events were reported in 8 of 381 patients treated with FVD regimen, of whom 2 required treatment2

Please refer to your country label for more information.

ALT=alanine transaminase.
AST=aspartate transaminase.
SGOT=serum glutamic oxaloacetic transaminase.
SGPT=serum glutamic pyruvic transaminase.

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; April 2016.
  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