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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.

Safety Profile 

Confidence In A Treatment You Can Manage1-8​​​​​

IBRANCE® has a well-characterised and consistent safety profile1-6​​​​​​​​​​​​​​

Overall Adverse Events (AEs) reported with IBRANCE®1* (n=872)​​​​​​​

Adapted from IBRANCE® Summary of Product Characteristics.

* 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.

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

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

§§ 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.

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

For the most up-to-date Safety Information, please refer to the full IBRANCE® Summary of Product Characteristics.

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*†​​​​​​

Neutropenia:

716 (82.1%)

Infections:

516 (59.2%)

Leukopenia:

424 (48.6%)

Fatigue:

362 (41.5%)

Nausea:

314 (36.0%)

Stomatitis:

264 (30.3%)

Anaemia:

258 (29.6%)

Diarrhoea: 

238 (27.3%)

Alopecia: 

234 (26.8%)

Thrombocytopenia: 

194 (22.2%)

Neutropenia:

716 (82.1%)

Infections:

516 (59.2%)

Leukopenia:

424 (48.6%)

Fatigue:

362 (41.5%)

Nausea: 

314 (36.0%)

Stomatitis:

264 (30.3%)

Anaemia:

258 (29.6%)

Diarrhoea:

238 (27.3%)

Alopecia:

258 (29.6%)

In all grades : 

Febrile neutropenia:​​​​​​​

12 (1.4%)

ILD/pneumonitis:​​​​​​​

12 (1.4%)

Febrile Neutropenia

12 (1.4%)              

ILD/Pneumonitis

12 (1.4%)

* 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

ILD/pneumonitis includes any reported PTs that are part of the Standardized MedDRA Query Interstitial Lung Disease (narrow).1 Monitor patients 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.1

Long Term Safety

No new safety signals were observed after an additional long-term follow-up of 37.6 months.8

† 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.
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 eruption1

​​​​​​​ Adverse Drug Reaction (ADR) : Identified post-marketing.


AE : Adverse Event, ALT : Alanine aminotransferase, AR : Adverse Reaction, AST : Aspartate aminotransferase, 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 PTs : Preferred Terms

References
  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Finn RS, et al. N Engl J Med. 2016;375:1925-1936.
  3. Cristofanilli M, et al. Lancet Oncol. 2016;17:425–39.
  4. Verma S, et al. Oncologist. 2016;21:1165-1175.
  5. Diéras V, et al. J Natl Cancer Inst. 2019;111(4):419-430.
  6. Diéras V, et al. Oncologist. 2019;24(12):1514-1525.
  7. Turner NC et al. N Engl J Med. 2018;379:1926–36.
  8. Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.
PP-IBR-GBR-4078. February 2022

Safety

IBRANCE® safety information and outcomes

  • Neutropenia
  • Adverse Events Management

Clinical Trials

  • Clinical Trial results for IBRANCE®
  • IBRANCE® Clinical Trials
  • PALOMA-2 Trial

    ​​​​​​​PALOMA-3 Trial

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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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