Common adverse events
The safety data for IBRANCE® in the PALOMA Clinical Programme is based on a pooled dataset from 872 patients who received IBRANCE® in combination with endocrine therapy (ET)(N=527 in combination with letrozole and N=345 in combination with fulvestrant) in 3 randomised clinical studies in hormone receptor positive, human epidermal growth factor 2-negative (HR+/HER2-) advanced or metastatic breast cancer (mBC).1
The most common (≥20%) adverse events of any grade reported in the PALOMA clinical trial programme were:1
The most common (≥2%) Grade ≥3 adverse events reported in the PALOMA clinical trial programme were:1
- Increased AST and ALT
Overall adverse events reported with IBRANCE® *
Adapted from IBRANCE® Summary of Product Characteristics.1
*Based on pooled data from 872 patients who received IBRANCE® in combination with ET (n=527 in combination with letrozole and n=345 in combination with fulvestrant) in 3 randomised clinical studies in HR+/HER2- advanced or mBC. Preferred Terms (PTs) are listed according to MedDRA 17.1. INFECTIONS includes all PTs that are part of the System Organ Class Infections and infestations. NEUTROPENIA includes the following PTs: Neutropenia, Neutrophil count decreased. LEUKOPENIA includes the following PTs: LEUKOPENIA, White blood cell count decreased. ANAEMIA includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased. THROMBOCYTOPENIA includes the following PTs: Thrombocytopenia, Platelet count decreased. +Adverse Drug Reaction (ADR) identified post-marketing. ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA. Query Interstitial Lung Disease (narrow). STOMATITIS includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis. RASH includes the following PTs: Rash, Rash maculopapular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.1
IBRANCE®-induced Grade ≥3 neutropenia is non-cumulative, reversible and has an early onset.2
Due to its on-target effect, IBRANCE®-induced neutropenia differs from that seen with chemotherapy (CT).2-4 Whilst IBRANCE® suppresses the bone marrow by inducing cell cycle arrest, CT kills bone marrow cells.3,4 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.1,4
IBRANCE®-induced neutropenia is rarely associated with fever (≤ 1.8%),2,5,6 and can be effectively managed by dose modification, without the need for growth factors and without compromising efficacy.2 It is infrequently associated with pancytopenia (3.2%)2 or leads to treatment discontinuation (≤ 1.6%).#2
In PALOMA-2, neutropenia was categorised according to the Medical Dictionary for Regulatory Activity preferred terms neutropenia and neutrophil count decreased.2
#Based on pooled dataset from 3 randomised studies (n=872). Preferred terms are listed according to MedDRA 17.1.1
ALT = alanine aminotransferase; AST = aspartate aminotransferase; MedDRA = Medical Dictionary for Regulatory Activities; NA = not applicable.
- IBRANCE® Summary of Product Characteristics.
- Verma S, et al. Oncologist. 2016;21:1165-1175.
- Johnson SM, et al. J Clin Invest. 2010;120:2528-2536.
- Hu W, et al. Clin Cancer Res. 2015;22(8):2000-2008.
- Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
- Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
Date of preparation: March 2020
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.