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Adverse event reporting can be found at the bottom of the page
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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.
Confidence In A Treatment You Can Manage1-9
a Preferred Terms (PTs) are listed according to MedDRA 17.1.
b Infections includes all PTs that are part of the System Organ Class Infections and infestations.
c Neutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.
d Leukopenia includes the following PTs: Leukopenia, White blood cell count decreased.
e Anaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
f Thrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.
g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
h Rash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.
i ILD/pneumonitis includes any reported PTs that are part of the Standardised MedDRA Query Interstitial Lung Disease (narrow).
j Venous Thromboembolism includes the following PTs: pulmonary embolism, embolism, deep vein thrombosis, peripheral embolism, thrombosis
* Adverse Drug Reaction (ADR) identified post-marketing.
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
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
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
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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PP-UNP-GBR-7812. January 2024