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

Monitoring Requirements

Confidence Through Simplicity1

The only routine monitoring requirement for IBRANCE® is complete blood counts, which should be taken prior to initiating IBRANCE® therapy and at the beginning of the first 6 cycles.

Complete blood counts 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, complete blood counts for subsequent cycles should be monitored every 3 months, prior to the beginning of a cycle and as clinically indicated.1

IBRANCE® Monitoring Requirements Table

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

Check that patients have a baseline ANC ≥1 x 109 cells/L and that platelet counts are ≥ 50 x 109 cells/L before starting treatment with IBRANCE®.

IBRANCE® full blood count (FBC) monitoring should be performed at the beginning of each cycle, at day 15 of the first 2 cycles, and as clinically indicated.

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

Cycle 1

Adapted from IBRANCE® Summary of Product Characteristics ​​​​​​​

Cycle 2

Adapted from IBRANCE® Summary of Product Characteristics ​​​​​​​

Cycle 3

Haematological Toxicities​​​​

Adapted from IBRANCE® Summary of Product Characteristics ​​​​​​​

​​​Grading according to CTCAE 4.0. 
* As per IBRANCE® Dosing guidelines1
Applies to all haematologic AEs except lymphopenia (unless associated with clinical events, e.g. opportunistic infections)1
ANC: Grade 1: ANC <LLN - 1.5 x 109 cells/L. Grade 2: ANC 1 - <1.5 x 109 cells/ L. Grade 3: ANC 0.5 - <1 x 109 cells/L. Grade 4: ANC < 0.5 x 109 cells/L1
§ Proactively monitor FBC1

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.


​​​​​​​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

Cardiovascular Information

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 (QTc) in an analysis of 125 breast cancer patients from the 1st line PALOMA-2 study evaluating the effect of IBRANCE® + letrozole on QTc*, where IBRANCE® did not prolong the QTc interval to a clinically relevant extent (<8 msec mean change from clock time-matched baseline).†1,5

Accordingly, IBRANCE® does not require electrocardiogram (ECG) monitoring, meaning that full blood counts (FBC) for haematological toxicities are the only regular monitoring requirement in clinical practice.ǂ1 

​​​​​​​One of the secondary objectives of the PALOMA-2 Study was to characterise the effects of IBRANCE® + letrozole at therapeutic doses vs letrozole + placebo on QTc: 76 patients in the IBRANCE®+ letrozole arm reported post-baseline ECG data. 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 3 ECG replicates. 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 (C1D14) time points and on C1D14 (± 2 days), triplicate ECGs clock time-matched to baseline ECG assessments on Day 0 (± 35 min) were obtained.5

​​​​​​​Patients were excluded from PALOMA-2 if they had myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4.0 grade ≥2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischaemic attack, or symptomatic pulmonary embolism in the previous 6 months, or had taken drugs known to prolong the QT interval within the last 7 days. Patients were also excluded if they had a QTc >480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or TdP or uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (e.g. hypocalcaemia, hypokalaemia, hypomagnesaemia).6

* PALOMA-2 was a randomised, double-blind, placebo-controlled, Phase III efficacy study that assessed the safety and efficacy of IBRANCE® + letrozole vs letrozole + placebo as 1st line treatment in 666 patients with ER+/HER2- mBC.2,5 

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 (QTcB), Fridericia’s correction (QTcF), and a study-specific correction factor (QTcS). 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 QTcF, QTcS, and QTcB were all <8 msec at all post-baseline time points in the QTc assessment period.5
​​​​​​​
Patients should be monitored for signs and symptoms of infection and treated as medically appropriate.1



ANC : Absolute Neutrophil Count, CBC : Complete Blood Count, CTCAE : Common Terminology Criteria for Adverse Events, ILD : Interstitial Lung Disease, LLN : Lower Limit of Normal

 ▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.

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. Ruiz-Garcia A, et al. SABCS 2016; poster P4-22-10.
  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-3728. July 2021

Dosing

Dosing and Monitoring requirements for IBRANCE®

  • IBRANCE® Dosing

Efficacy

Efficacy results for IBRANCE®

  • IBRANCE® Efficacy

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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