One scheduled monitoring provision

IBRANCE® is the only CDK4/6 inhibitor with one scheduled monitoring provision in its current SmPC1

  • The current SmPC for IBRANCE® does not include provisions for ECG, electrolyte, or LFT monitoring1
  • CBC is the only scheduled monitoring provision included:1
    • CBC should be monitored prior to the start of IBRANCE® therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated
    • For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, CBC for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated

one-scheduled-monitoring-provision

 

 

  • Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE® when taken in combination with ET1
  • Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea):1
  • In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE® immediately and evaluate the patient
  • Permanently discontinue IBRANCE® in patients with severe ILD/pneumonitis
  • Patients should be monitored for signs and symptoms of infection and treated as medically appropriate1
  • Additional monitoring may be necessary based on the individual patient1

 

Adapted from IBRANCE® Summary of Product Characteristics.1

CBC = complete blood count; CDK = cyclin-dependent kinase; ECG = electrocardiogram;  ET = endocrine therapy; ILD = interstitial lung disease; LFT = liver function test; SmPC = Summary of Product Characteristics.

Reference
1. IBRANCE® Summary of Product Characteristics.
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

©2020 Pfizer. All rights reserved. PP-IBR-IRL-0501 Date of Preparation: March 2022 Legal Category: S1A