For Health Care Professionals Outside the US

 
 
 

Dosing modifications

Dose changes may be required for FARYDAK1

The recommended starting dose for FARYDAK is 20 mg, taken orally on assigned days.1

  • If a patient experiences adverse events, dose modification may be required based on individual tolerability1

If a dose reduction for FARYDAK is required:

Dose and/or schedule modifications of FARYDAK may be required if a patient experiences adverse events. The values below are based on the clinical trial protocols for these selected adverse events. The information is intended to help you manage the selected adverse events that may occur in patients treated with FARYDAK/bortezomib (BTZ)/dexamethasone (dex). In the clinical trial, the most common adverse events (nonhaematologic and haematologic) were thrombocytopenia, neutropenia, diarrhoea, and fatigue.1 The labels for BTZ and dex should be consulted if dose modifications are required for these drugs.

For patients >75 years of age, depending on the patient’s general condition and concomitant diseases, an adjustment of the starting doses or schedule of the components of the combination regimen may be considered.1

NOTE: Patients with mild hepatic impairment should be started at a modified dose. View the recommended starting modifications for patients with hepatic impairment.1

Reference:

  1. FARYDAK® (panobinostat). EU Summary of Product Characteristics. Novartis AG; August 2015.

Need more information on AEs? See discontinuation rates