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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
 
Videos

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.

Title
IBRANCE® (palbociclib) is indicated for the treatment of HR+ HER2- locally advanced or metastatic breast cancer in combination with an AI, or in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.1
Safety Profile

Confidence In A Treatment You Can Manage1-9

IBRANCE® has a well-characterised and consistent safety profile1-9Overall Adverse Events (AEs) reported with IBRANCE®1* (n=872)

The adverse reactions listed here are very common and common. They are listed by system organ class and frequency category. Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10). For all other adverse events, please refer to the SPC.1

a 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.

f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.

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 maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.

ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query Interstitial Lung Disease (narrow).

Venous Thromboembolism includes the following PTs: pulmonary embolism, embolism, deep vein thrombosis, peripheral embolism, thrombosis

* Adverse Drug Reaction (ADR) identified post-marketing.

Most Frequent Adverse Events of Any Grade (n=872)

The most frequent (≥20%) Adverse Events of any grade observed across the PALOMA Clinical Trial Programme were:1†a

In all grades

a PTs : Are listed according to MedDRA 17.1.
* Adverse Drug Reaction (ADR) : Identified post-marketing.
† 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 three randomised clinical studies in HR+/HER2- advanced or mBC1

IBRANCE® Most Common Grade >3 Adverse Reactions ILD/Pneumonitis

Patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea). In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE® immediately and evaluate the patient. Permanently discontinue IBRANCE® in patients with severe ILD or pneumonitis. Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with endocrine therapy. Across clinical studies (PALOMA-1, PALOMA-2, PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade.1

Venous Thromboembolism

VTEs were reported in 3.2% of patients treated with IBRANCE across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3). Patients should be monitored for signs and symptoms of DVT and PE, and treated as medically appropriate.1

For the most up to date safety profile information and guidance on the management of treatment related adverse events, please refer to the full IBRANCE® Summary of Product Characteristics.

AE : Adverse Event, ALT : Alanine aminotransferase, AR : Adverse Reaction, AST : Aspartate aminotransferase, DVT: Deep Vein Thrombosis, ET : Endocrine Therapy, HR+/HER2– : Hormone Receptor Positive / Human Epidermal growth factor Receptor 2 Negative, ILD : Interstitial Lung Disease, mBC : metastatic Breast Cancer, MedDRA : Medical Dictionary for Regulatory Activities, N/n : Number of patients, NA : Not Applicable PE: Pulmonary Embolism, PTs : Preferred Terms VTE: Venous Thromboembolic Event

References

IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.Finn RS, et al. N Engl J Med. 2016;375:1925-1936.Cristofanilli M, et al. Lancet Oncol. 2016;17:425–39.Verma S, et al. Oncologist. 2016;21:1165-1175.Diéras V, et al. J Natl Cancer Inst. 2019;111(4):419-430.Diéras V, et al. Oncologist. 2019;24(12):1514-1525.Turner NC et al. N Engl J Med. 2018;379:1926–36.Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.Finn RS, et al. Oral presentation LBA1003. ASCO 2022.
PP-IBR-GBR-5773. May 2024
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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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