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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.

Safety Profile 

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

IBRANCE® has a well-characterised and consistent safety profile1-5​​​​​​​​​​​​​​

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

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

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: 

258 (29.6%)

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%)

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* 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, dyspneoa). 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.1

† 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

 ▼ 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.

References
  1. 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.
  2. Cristofanilli M, et al. Lancet Oncol. 2016;17:425–39.
  3. Verma S, et al. Oncologist. 2016;21:1165-1175.
  4. Diéras V, et al. J Natl Cancer Inst. 2019;111(4):419-430.
  5. Diéras V, et al. Oncologist. 2019;24(12):1514-1525.
  6. Turner NC et al. N Engl J Med. 2018;379:1926–36.
  7. Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.
PP-IBR-GBR-3729. July 2021

Safety

IBRANCE® safety information and outcomes

  • Neutropenia
  • Adverse Events Management

Efficacy

Efficacy results for IBRANCE®

  • IBRANCE® Efficacy

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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