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Clinical efficacy & safetyPALOMA-2Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)PALOMA-2 summaryPALOMA-3Trial design overviewPatient baseline characteristicsProgression-free survival (primary endpoint)Overall survival (secondary endpoint)Tumour control (secondary endpoint)SafetySafety overviewPooled laboratory abnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected safety featuresIBRANCE long-term safetyGI and liver toxicitiesEffect of IBRANCE on QTc intervalElderly patientsVisceral disease patientsDose reduction effect on efficacyRW evidenceValue of RWEWhat is real-world evidence?What is the value of RWE?P-REALITY and P-REALITY XP-REALITY OverviewP-REALITY OS and rwPFSP-REALITY X OverviewP-REALITY X OS and rwPFSIRISIRIS OverviewIRIS PFS and OSPOLARIS POLARIS OverviewPOLARIS Patient-Reported OutcomesMADELINEMADELINE OverviewMADELINE Patient CharacteristicsMADELINE Patient-Reported OutcomesPalomAGEPalomAGE OverviewRWE in Older Patients with mBCPatient-reported outcomesPALOMA-2: FACT-B scoresPALOMA-3: EORTC QLQ-C30 scoresPALOMA-3: Time to deterioration in pain symptomsDosingRecommended dosing scheduleRecommended dose modifications for AEsMonitoringOne scheduled monitoring provision ResourcesMaterials
IBRANCE-associated AEs may be effectively managed using a clear dose-modification schedule1

Adapted from IBRANCE Summary of Product Characteristics.1

Dose reductions or dose modifications due to any AE occurred in 38.4% of patients receiving IBRANCE in randomised clinical studies regardless of the combination1

*If further dose reduction below 75 mg/day is required, discontinue the treatment1

Dose Modification and Management of Haematological Toxicities1Cycle 1 Cycle 2

Cycle 3

  • CBC to be repeated on Day 1 of each following cycle
  • For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, CBCs for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated
     
  • Dose reductions for uncomplicated Grade 3 neutropenia should only be performed at the initiation of a cycle and not during a cycle
     

Dose Modification and Management of Non-haematological Toxicities1

All cyclesDose modification includes temporary dose interruptions, cycle delays, and/or reductions.
Grading according to CTCAE 4.0.2
Applies to all haematological adverse events except lymphopenia (unless associated with clinical events, e.g. opportunistic infections). ANC: Grade 1: ANC <LLN – 1500/mm3; Grade 2: ANC 1000 – <1500/mm3; Grade 3: ANC 500 – <1000/mm3; ​​​​​​​Grade 4: ANC <500/mm3Proactively monitor CBC.

AE = adverse event; ANC = absolute neutrophil count; CBC = complete blood count; CTCAE = Common Terminology Criteria for Adverse Events; HR+/HER2 - = hormone receptor-positive, human epidermal growth factor receptor 2-negative; LLN = lower limit of normal.

Example

Example

Additional Monitoring

Management of Interstitial Lung Disease (ILD)/Pneumonitis, Venous Thromboembolism and Febrile Neutropenia1

 

 

ILD/Pneumonitis

Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients had ILD/Pneumonitis of any grade. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea). In patients who have new of 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

 

 

Venous Thromboembolism

Any grade 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

 

 

Febrile Neutropenia

Across clinical studies (PALOMA-1, PALOMA-2 and PALOMA-3), 1.4% of IBRANCE-treated patients experienced febrile neutropenia of any grade. In cases of febrile neutropenia, IBRANCE should be withheld until recovery of neutropenia to Grade <2 and then resumed at the next lower dose at the beginning of the following cycle.1

 

The overall safety profile of IBRANCE is based on pooled data from 872 patients who received palbociclib in combination with endocrine therapy (N=527 in combination with letrozole and N=345 in combination with fulvestrant) in randomised clinical studies in HR+ HER2-negative advanced or metastatic breast cancer.

 

 

For the most up-to-date safety profile information, please refer to the full IBRANCE® Summary of Product Characteristics.

ILD = interstitial lung disease, VTE = venous thromboembolism, DVT = deep vein thrombosis, PE = pulmonary embolism

 

References:IBRANCE Summary of Product Characteristics.

National Cancer lnstitute. CTCAE v.4.0. Available at: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03 CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Accessed November 2023.

Recommended dosing
IBRANCE Summary of Product Characteristics Product Characteristics Loading

Legal Category: S1A
Further information is available upon request

PP-IBR-IRL-0685. November 2023

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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