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Adverse event reporting can be found at the bottom of the page
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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for the UK. IBRANCE® (palbociclib) Prescribing Information for the UK click here. Adverse event reporting information can be found at the bottom of the page.
Click for more information on the Safety Profile and the Adverse Event Management page.
Complete blood count 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.1
For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, complete blood counts for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated.
Absolute neutrophil counts of ≥ 1,000/mm3 and platelet counts of ≥ 50,000/mm3 are recommended to receive IBRANCE®.1
Neutropenia (any grade) was the most frequently reported adverse event (AE) for IBRANCE® (palbociclib) in combination with endocrine therapy (ET) across the Phase III IBRANCE® clinical trial programme (N=872):1*
Incidence of neutropenia was recorded in a population of pre-/peri- and post-menopausal women with HR+/HER2- locally advanced breast cancer with relapse or progression on or after ET in the adjuvant setting or within 1 month after receiving ET for metastatic breast cancer, randomised to receive IBRANCE® + fulvestrant (n=345), or placebo + fulvestrant (n=172). Data from all randomly assigned patients who received at least one dose of IBRANCE® plus fulvestrant.2
Adapted from Verma S, et al. Oncologist. 2016;21:1165-752.
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.1
In clinical studies and clinical practice, most cases of Grade ≥3 neutropenia occurred during the first two cycles of treatment IBRANCE®.1,2,9
In vitro data suggest that due to its mechanism of action, IBRANCE®-associated neutropenia differs from that seen with chemotherapy.2,10,11
It is thought that whilst IBRANCE® suppresses the bone marrow by inducing cell cycle arrest, chemotherapy causes cellular death, including bone marrow cells.10,11
The 3:1 IBRANCE® dosing schedule provides a 1-week recovery period that allows arrested bone marrow cells to resume their function, while tumour cell growth remains suppressed by the concomitant ET partner.1,11
| IBRANCE®-Associated Neutropenia10,11 | Chemotherapy-Associated Neutropenia11,12 | |
|---|---|---|
| Mechanism | Cell cycle arrest but no death of profilerating neutrophil precursors | DNA damage and apoptosis of profilerating neutrophil precursors |
| Reversibility | Rapid recovery upon IBRANCE® withdrawal | Delayed recovery |
For full safety profile information and guidance on the management of adverse events, please refer to the IBRANCE Summary of Product Characteristics.
*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- mBC.1
† PALOMA-2 was a randomised, double-blind, placebo-controlled, Phase 3 study assessing the efficacy and safety of IBRANCE® plus letrozole versus placebo plus letrozole as first-line treatment in post-menopausal women with endocrine receptor-positive, human epidermal growth factor receptor-negative (ER+/HER2-) advanced breast cancer, who had received no prior systemic therapy for advanced disease.4,6
‡ PALOMA-3 was a randomised, double-blind, placebo-controlled, Phase 3 study assessing the efficacy and safety of IBRANCE® plus fulvestrant versus placebo plus fulvestrant for patients with HR+/HER2- metastatic breast cancer that had progressed on previous endocrine therapy.5,8
AE : adverse event, ER : endocrine receptor, ET : endocrine therapy, HR+/HER2– : hormone receptor positive / human epidermal growth factor receptor-2 negative
References
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search
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Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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