The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
Confidence in a Treatment you can Manage1-6
Adapted from Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–292
Adapted from Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.2
a All AEs regardless of suspected causal relationship to the study medication; MedDRA (v20.0) coding dictionary applied.2
b Clustered Preferred Terms (PTs) (any event having a PT that is equal to those listed):
anemia includes the PTs anemia, hematocrit decreased, and hemoglobin decreased;
infections includes any PT under the system organ class infections and infestations;
leukopenia includes leukopenia and white blood cell count decreased;
neutropenia includes neutropenia and neutrophil count decreased;
rash includes dermatitis, dermatitis acneiform, rash, rash erythematous, rash maculopapular, rash popular, rash pruritic, and toxic skin eruption;
stomatitis includes aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oropharyngeal discomfort, oropharyngeal pain, and stomatitis;
thrombocytopenia includes platelet count decreased and thrombocytopenia.2
c In the palbociclib-letrozole arm, grade 3 and 4 febrile neutropenia were reported in 7 (1.6%) and 1 (0.2%) patients, respectively, at the time of the primary analysis (data cutoff date February 26, 2016) and in 7 (1.6%) and 2 (0.5%) patients after the additional 15 months of follow-up (data cutoff date May 31, 2017). The later data cutoff date included an additional 1 (0.2%) patient who developed grade 4 febrile neutropenia with a very slight fever (38.2 ºC) 1 week after the study drug was permanently discontinued. Because the onset of grade 3 or 4 febrile neutropenia takes a median 28 days to emerge after palbociclib is stopped and residual neutropenia is not uncommon for chemotherapy (nab-paclitaxel was the subsequent line of treatment) 7 days after its discontinuation, the chemotherapy appears to contribute to this SAE.2
d Grade 5 AEs in the palbociclib-letrozole arm were disease progression (n=3), infection (pneumonia) and respiratory failure, pulmonary embolism, acute myocardial infarction, breast cancer, breast cancer metastatic, cardiogenic shock, cardiopulmonary failure, cardiovascular insufficiency and death (all n=1): note, 1 patient had grade 5 pneumonia (infection) and grade 5 respiratory failure; grade 5 AEs in the placebo-letrozole arm were infections (n=3), pulmonary embolism, and cardiac arrest (both n=1); note: grade 5 pulmonary embolism and grade 5 lower respiratory tract infection were reported in 1 patient.2
For full safety information please consult the IBRANCE ® Summary of Product Characteristics
IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results
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IBRANCE® safety information and outcomes
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