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Adapted from IBRANCE Summary of Product Characteristics.1
Dose reductions or dose modifications due to any AE occurred in 38.4% of patients receiving IBRANCE in randomised clinical studies regardless of the combination1
*If further dose reduction below 75 mg/day is required, discontinue the treatment1
Dose Modification and Management of Non-haematological Toxicities1
AE = adverse event; ANC = absolute neutrophil count; CBC = complete blood count; CTCAE = Common Terminology Criteria for Adverse Events; HR+/HER2 - = hormone receptor-positive, human epidermal growth factor receptor 2-negative; LLN = lower limit of normal.
Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/Pneumonitis of any grade. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea). In patients who have new of 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 or pneumonitis.1
Any grade VTEs were reported in 3.2% of patients treated with IBRANCE across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3). Patients should be monitored for signs and symptoms of DVT and PE, and treated as medically appropriate.1
Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients experienced febrile neutropenia of any grade. In cases of febrile neutropenia, IBRANCE should be withheld until recovery of neutropenia to Grade <2 and then resumed at the next lower dose at the beginning of the following cycle.1
The overall safety profile of IBRANCE is based on pooled data from 872 patients who received palbociclib in combination with endocrine therapy (N=527 in combination with letrozole and N=345 in combination with fulvestrant) in randomised clinical studies in HR+ HER2-negative advanced or metastatic breast cancer.
For the most up-to-date safety profile information, please refer to the full IBRANCE® Summary of Product Characteristics.
ILD = interstitial lung disease, VTE = venous thromboembolism, DVT = deep vein thrombosis, PE = pulmonary embolism
National Cancer lnstitute. CTCAE v.4.0. Available at: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03 CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed November 2023.
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PP-UNP-IRL-0176. January 2023