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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics for Great Britain and Northern Ireland. IBRANCE® (palbociclib) Prescribing Information for Great Britain and Northern Ireland click here.  Adverse event reporting information can be found at the bottom of the page.

Monitoring Requirements

Confidence Through Simplicity​​​​​​​

The only routine monitoring requirement for IBRANCE® is FBCs, which should be taken prior to initiating IBRANCE® therapy and at the beginning of the first 6 cycles. FBCs should also be taken on Day 15 of the first 2 cycles, as clinically indicated.1

​​​​​​​For patients who experience a maximum of Grade 1 or 2 neutropenia in the first 6 cycles, FBCs for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated.1


Patients who experience Grade ≥3 haematological toxicities at any point should not be placed on 3-monthly monitoring.

Patients should have an ANC of ≥1000/mm3 and platelet counts of ≥50,000/mm3 before they can receive treatment with IBRANCE®.

IBRANCE® Monitoring Requirements Table

*Please refer to the full IBRANCE® Summary of Product Characteristics for management of patients with pre-existing severe hepatic and renal impairment for prescribing and monitoring guidance.1

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IBRANCE® haematological adverse events, including neutropenia, can be managed through scheduled FBC monitoring and dose modifications (temporary dose interruptions, cycle delays, and/or reductions).1

Check that patients have a baseline ANC ≥1000/mm3 and that platelet counts are ≥50,000/mm3 before starting treatment with IBRANCE®.1

IBRANCE® FBC monitoring should be performed at the beginning of each cycle, at Day 15 of the first 2 cycles, and as clinically indicated.1

​​​​​​​The dose of IBRANCE® may need to be modified depending on the results of the FBC tests.1

Haematological Toxicities​​​​

Adapted from IBRANCE® Summary of Product Characteristics ​​​​​​​
​​​​​​​Grading according to CTCAE 4.0.
*ANC: Grade 1: ANC <LLN – 1500/mm3; Grade 2: ANC 1000 – <1500/mm3; Grade 3: ANC 500–<1000/mm3; Grade 4: ANC <500/mm3.
Figure applies to all haematological adverse reactions except lymphopenia (unless associated with clinical events, e.g. opportunistic infections).1

Non-Haematological Toxicities

Non-haematologic toxicities can be managed through dose modifications (temporary dose interruptions, cycle delays, and/or reductions).1

Adapted from the IBRANCE® Summary of Product Characteristics1

Grading according to CTCAE 4.01
* Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3). 1.4% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% 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.1


​​​​​​​Monitor patients 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.1

IBRANCE® does not require ECG monitoring, meaning that FBCs for haematological toxicities are the only regular monitoring requirement in clinical practice.*1
​​

​​​​​​​IBRANCE® Cardiac Monitoring in PALOMA-2​​​​​​​

The overall consistent and manageable1–4 safety profile of IBRANCE® is also true in terms of cardiac safety, having demonstrated no clinically relevant effects on the QT interval corrected for heart rate (<8 msec mean change from clock time-matched baseline).‡1,5

Cardiac Monitoring in PALOMA-2 Study Design

One of the secondary objectives of the PALOMA-2 study was to characterise the effects of IBRANCE® plus letrozole at therapeutic doses versus letrozole plus placebo on QTc: 77 patients in the IBRANCE® plus letrozole arm reported post-baseline ECG data.1,5

Routine ECG monitoring for pharmacovigilance and comprehensive QTc evaluation were included: 12-lead (with a 10-second rhythm strip) tracings were performed in triplicate ~2 minutes apart but within 10 minutes for all three ECG replicates.5


On Day 0 (baseline) triplicate ECGs were obtained at time 0, 2, 4, 6 and 8 hours and clock time-matched to Cycle 1 Day 14 time points and on Cycle 1 Day 14 (±2 days), triplicate ECGs clock time-matched to baseline ECG assessments on Day 0 (± 35 minutes) were obtained.5

PALOMA-2 Cardiac Exclusion Criteria

Cardiovascular Information 

 *Patients should be monitored for signs and symptoms of infection and treated as medically appropriate.
†PALOMA-2 was a randomised, double-blind, placebo-controlled, Phase III efficacy study that assessed the safety and efficacy of IBRANCE® plus letrozole versus letrozole plus placebo as first-line treatment in 666 patients with HR+/HER2- mBC.2
‡Based on a random-effect model to estimate the mean change in ECG parameter data from clock time-matched baseline at each post-baseline nominal time point. Three correction methods for the effect of heart rate on QT interval were included: Bazett’s correction (QTcF), Fridericia’s correction (QTcB), and a study-specific correction factor (QTcS). The QTcS provided the best correction, followed by QTcF and QTcB. The QTcS, along with QTcF, were used for QTc analysis data interpretation and conclusion. The results of the QTcB analyses were included for completeness. The upper bounds of the 1-sided 95% CI for the mean change from clock time-matched baseline for QTcS, QTcF, and QTcB were all <8 msec at all post-baseline time points in the QTc assessment period.5​​​​​​​


ANC : Absolute Neutrophil Count, ECG : Electrocardiogram, FBC : Full Blood Count, CTCAE : Common Terminology Criteria for Adverse Events, ILD : Interstitial Lung Disease, LLN : Lower Limit of Normal, QTc : corrected QT interval, TdP : Torsades de pointes
References
  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
  3. Verma S, et al. Oncologist. 2016;21:1165-1175.
  4. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-430.
  5. Durairaj C, Ruiz-Garcia A et al. Anticancer Drugs. 2018;29(3):271-280.
  6. IBRANCE EPAR Public assessment report. 25 Nov 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/003853/WC500217198.pdf. Accessed May 2017.
PP-IBR-GBR-4071. February 2022

Dosing

Dosing and Monitoring requirements for IBRANCE®

  • IBRANCE® Dosing

Clinical Trials

  • Clinical Trial results for IBRANCE®
  • IBRANCE® Clinical Trials
  • PALOMA-2 Trial

    ​​​​​​​PALOMA-3 Trial

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Safety

IBRANCE® safety information and outcomes

  • IBRANCE® Safety Profile
  • Neutropenia
  • Adverse Event Management

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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PP-PFE-GBR-3863. November 2021

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