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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

Monitoring

One Scheduled Monitoring Provision
Support & Resources

Summary of Prescibing Information

TabletCapsule

One Scheduled Monitoring Provision

PALBACE® Is the only CDK4/6 Inhibitor With 1 Scheduled Monitoring Provision in Its Current LPD1

  

CBC is the only scheduled monitoring provision included1:

  • CBC should be monitored prior to the start of the PALBACE® therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated
  • For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, CBC for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated  

  

Example

   

Adapted from Palbace. Local product document. 2021.1

   

Additional monitoring may be necessary based on the individual patient.1

   

Additional Monitoring

  • Severe, life-threatening or fatal ILD and/or pneumonitis can occur in patients treated with PALBACE® when taken in combination with ET1
  • Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g. hypoxia, cough and dyspnoea)1:
    • In patients who have new or worsening respiratory symptoms and are suspected to have developed ILD/pneumonitis, interrupt PALBACE® immediately and evaluate the patient
  • Permanently discontinue PALBACE® in patients with severe ILD/pneumonitis 
  • Patients should be monitored for signs and symptoms of infection and treated as medically appropriate1
Additional monitoring may be necessary based on the individual patient.1

   

CBC, complete blood count; CDK, cyclin-dependent kinase; ECG, electrocardiogram; ET, endocrine therapy; ILD,  interstitial lung disease; LFT, liver function test; LPD, local product document.

   

Reference:

Palbace. Local product document. Pfizer; 2021. Version LPDPAB102021.

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.

    

PP-IBR-IND-0462 27 July 2022

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Monitoring

Clinical Efficacy & Safety

PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC

Learn more

   

Dosing

Recommended dosing schedule and dose modifications for AEs

Learn more

   

Monitoring

One scheduled monitoring provision

Learn more
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