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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 mBCP-VERIFYP-VERIFY StudyPatient-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 provisionPrescribing Information 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 4.0.2Applies 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/mm3. Proactively 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

 

ILD/Pneumonitis

  • Severe, life-threatening, or fatal ILD and/or pneumonitis can occur in patients treated with IBRANCE when taken in combination with ET1
  • Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough, dyspnoea):1
    • In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt IBRANCE immediately and evaluate the patients.
  • Permanently discontinue IBRANCE in patients with severe ILD/pneumonitis 

 

Infections

  • IBRANCE has myelosuppressive properties, so it may predispose patients to infections. 
  • Patients should be monitored for signs and symptoms of infection and treated as medically appropriate.
  • Physicians should inform patients to promptly report any episodes of fever.1
 

Venous Thromboembolism

  • VTEs were reported in patients treated with IBRANCE. Patients should be monitored for signs and symptoms of DVT and PE, and treated as medically appropriate.


Additional monitoring may be necessary based on the individual patient1

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: Common Terminology Criteria for Adverse Events (CTCAE) Accessed February 2025.
Recommended dosing
IBRANCE Summary of Product Characteristics Product Characteristics Loading

Legal Category: S1A
Further information is available upon request

PP-IBR-IRL-0746. March 2025

Adverse events should be reported.

If you wish to make a medical information inquiry or report an adverse event please contact Pfizer on 1800 633 363 
or email Pfizer at [email protected] or visit www.PfizerMedicalInformation.ie

Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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