IBRANCE® (palbociclib)| Safety Overview | PfizerPro Ireland

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Clinical efficacy & safety

PALOMA-2

Trial design overview

Patient baseline characteristics

Progression-free survival (primary endpoint)

Overall survival (secondary endpoint)

Tumour control (secondary endpoint)

PALOMA-2 summary

PALOMA-3

Trial design overview

Patient baseline characteristics

Progression-free survival (primary endpoint)

Overall survival (secondary endpoint)

Tumour control (secondary endpoint)

Safety

Safety overview

Pooled laboratory abnormalities

PALOMA-2 AEs

PALOMA-3 AEs

Selected safety features

IBRANCE long-term safety

GI and liver toxicities

Effect of IBRANCE on QTc interval

Elderly patients

Visceral disease patients

Dose reduction effect on efficacy

RW evidence

Value of RWE

What is real-world evidence?

What is the value of RWE?

P-REALITY and P-REALITY X

P-REALITY Overview

P-REALITY OS and rwPFS

P-REALITY X Overview

P-REALITY X OS and rwPFS

IRIS

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IRIS PFS and OS

POLARIS

POLARIS Overview

POLARIS Patient-Reported Outcomes

MADELINE

MADELINE Overview

MADELINE Patient Characteristics

MADELINE Patient-Reported Outcomes

PalomAGE

PalomAGE Overview

RWE in Older Patients with mBC

Patient-reported outcomes

PALOMA-2: FACT-B scores

PALOMA-3: EORTC QLQ-C30 scores

PALOMA-3: Time to deterioration in pain symptoms

Dosing

Recommended dosing schedule

Recommended dose modifications for AEs

Monitoring

One scheduled monitoring provision

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Safety Profile

Confidence In A Treatment You Can Manage^1-9

IBRANCE® has a well-characterised and consistent safety profile^1-9

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

IBRANCE Summary of Product Characteristics

Product Characteristics

^a Preferred Terms (PTs) are listed according to MedDRA 17.1.

^bInfections includes all PTs that are part of the System Organ Class Infections and infestations.

^cNeutropenia includes the following PTs: Neutropenia, Neutrophil count decreased.

^dLeukopenia includes the following PTs: Leukopenia, White blood cell count decreased.

^eAnaemia includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.

^fThrombocytopenia includes the following PTs: Thrombocytopenia, Platelet count decreased.

^gStomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.

^hRash includes the following PTs: Rash, Rash maculo-papular, Rash pruritic, Rash erythematous, Rash papular, Dermatitis, Dermatitis acneiform, Toxic skin eruption.

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

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

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

IBRANCE Summary of Product Characteristics

Product Characteristics

Most Common Adverse Events of Any Grade (n=872)¹

The most common (≥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 and Grade 4 Adverse Reactions¹

ILD/Pneumonitis¹

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.¹0.1% had Grade 3 and no Grade 4 or fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.

Venous Thromboembolism¹

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

Palbociclib and Statins¹

Concomitant use of palbociclib with statins which are substrates of CYP3A4 and/or BCRP may increase the risk of rhabdomyolysis due to increased statin plasma concentration. Cases of rhabdomyolysis including fatal cases have been reported following coadministration of palbociclib with simvastatin or atorvastatin.^†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.

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.

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PP-IBR-IRL-0718. September 2024

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Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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