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DosingDosingIBRANCE® Dosing
 
Monitoring Requirements
SafetySafetyIBRANCE® Safety ProfileNeutropeniaAdverse Event ManagementClinical Trials
Clinical TrialsIBRANCE® Clinical TrialsIBRANCE® PALOMA-2 Trial
 
IBRANCE® PALOMA-3 Trial
Real World EvidenceReal World EvidenceIBRANCE® Real World EvidenceIRIS (UK) StudyROIS
 
P-REALITY X
Patient ProfilesThe Ibrance® PatientPatient ProfilesAlison - >65 years with comorbiditiesBecky - Postmenopausal with bone-only diseaseSupport and ResourcesSupport and ResourcesIBRANCE Service SupportMaterials
 
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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.

PALOMA-3 Trial Safety Profile

Confidence Built on Evidence1-4

Adapted from Turner NC et al., 2018 supplementary appendix

Adapted from Turner NC et al., 2018 supplementary appendix

In the PALOMA-3 trial, neutropenia was the most frequently reported AE of any grade occurring in 84.1% of patients treated with palbociclib + fulvestrant (n=345). Febrile neutropenia occurred in ~1% of these patients.3

Neutropenia can often be managed with IBRANCE dose interruptions/delays or dose reductions.4

Permanent discontinuation of IBRANCE® due to any adverse event was necessary in 5.2% of patients across the PALOMA trials.4

*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.

Treatment-Emergent Adverse Event Reported in ≥10% of patients in the palbociclib plus fulvestrant arm3

Please refer to the Ibrance SmPC for full safety profile information and guidance on dose modifications and the management of treatment related AEs.

Adapted from Turner NC, et al. 2018, supplementary appendix.3

In a population of pre-/peri- and post-menopausal women with HR+/HER2- advanced or metastatic breast cancer who had progressed on previous ET therapy.3
Grading according to CTCAE 4.0.4
PTs are listed according to MedDRA 17.1:4
*Neutropenia includes neutropenia and neutrophil count decreased; †Leukopenia includes leukopenia and white blood cell count decreased;‡Infections includes any PT under the system organ class infections and infestations; §Anaemia includes the PTs anaemia, haematocrit decreased, and haemoglobin decreased; ¶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; ††Rash includes dermatitis, dermatitis acneiform, rash, rash erythematous, rash maculopapular, rash popular, rash pruritic, and toxic skin eruption.

For full safety profile information, please refer to the IBRANCE SmPC.

AE : Adverse Event, AI: Aromatase Inhibitor, AST ; aspartate aminotransferase, CTCAE : Common Terminology Criteria for Adverse Events, ET : endocrine therapy,  HR+/ HER2- : Hormone Receptor‑Positive/ Human Epidermal Growth Factor Receptor 2-Negative, LHRH : Luteinising Hormone-Releasing Hormone, MedDRA : Medical Disctionary for Regulatory Activities,  PT : Preferred Term,  SmPC : Summary Of Product Characteristics.

References

Cristofanilli M, et al. Lancet Oncol 2016;17:425–439.Cristofanilli M, et al. ECJ 2018;104:21-31.Turner NC, et al. N Engl J Med 2018;379:1926–1936 including supplementary appendix.IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
PP-IBR-GBR-5174. June 2023

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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