Ibrance is indicated for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy.1

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:
    • 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
  • 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® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.

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All rights reserved. Date of preparation: June 2020 PP-IBR-GLB-0254

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