The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain. IBRANCE® (palbociclib) Prescribing Information for Great Britain click here. IBRANCE® (palbociclib) Prescribing Information for Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.
PALOMA-2 Trial Safety Profile
Confidence in a Treatment you can manage1-6
Treatment-emergent AEs of any cause reported in >10% of patients in either arm (safety population)2
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, 1 patient had grade 5 pneumonia (infection) and grade 5 respiratory failure.2
For full safety information please consult the IBRANCE ® Summary of Product Characteristics
▼ 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.
- IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
- Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.
- Finn RS, et al. N Engl J Med. 2016;375:1925-1936.
- Cristofanilli M, et al. Lancet Oncol. 2016;17:425–39.
- Turner NC, et al. Ann-Oncol. 2018;29:669-80.
- Verma S, et al. Oncologist. 2016;21:1165-117.
PALOMA-2 Trial
IBRANCE® + Aromatase Inhibitor (AI) Clinical Trial Results
IBRANCE® PALOMA-2 Trial Study Design Efficacy Outcomes Quality of Life Outcomes IBRANCE® Mode of Action
Clinical Trials
- Clinical Trial results for IBRANCE®
IBRANCE® Clinical Trials PALOMA-2 Trial
Safety
IBRANCE® safety information and outcomes
IBRANCE® Safety Profile Neutropenia Adverse Event Management
Indication
- IBRANCE® is indicated for the treatment of HR+/HER2- locally advanced or metastatic breast cancer:
- In combination with an aromatase inhibitor; or
- In combination with fulvestrant in women who have received prior ET
In pre- or perimenopausal women, the ET should be combined with a LHRH agonist
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