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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.
Confidence In A Treatment You Can Manage1-8
Dose Adjustments
Dose modification of IBRANCE is recommended based on individual tolerability.
Management of some adverse reactions may require temporary dose interuptions/delays, and/or dose reductions, or permanent discontinuation as per dose reduction schedules as per schedule below.
IBRANCE recommended dose modifications for adverse reactions1
Dose Levels | Dose |
---|---|
Recommended Dose | 125 mg/day |
First Dose Reduction | 100 mg/day |
Second Dose Reduction | 75 mg/day* |
IBRANCE dose modification and management – Haematological toxicities1
Complete blood count should be monitored prior to the start of IBRANCE therapy and at the beginning of each cycle, as well as on Day 15 of the first 2 cycles, and as clinically indicated.
Absolute neutrophil counts (ANC) of ≥ 1,000/mm3 and platelet counts of ≥ 50,000/mm3 are recommended to receive IBRANCE.
CTCAE Grade | Dose Modifications |
---|---|
Grade 1 or 2 | No dose adjustment is required. |
Grade 3a | Day 1 of cycle: Withhold IBRANCE, until recovery to Grade ≤ 2, and repeat complete blood count monitoring within 1 week. When recovered to Grade ≤ 2, start the next cycle at the same dose. Day 15 of first 2 cycles: If Grade 3 on Day 15, continue IBRANCE at the current dose to complete cycle and repeat complete blood count on Day 22. If Grade 4 on Day 22, see Grade 4 dose modification guidelines below. Consider dose reduction in cases of prolonged (> 1 week) recovery from Grade 3 neutropenia or recurrent Grade 3 neutropenia on Day 1 of subsequent cycles. |
Grade 3 ANCb (<1,000 to 500/mm3) + Fever ≥ 38.5 ºC and/or infection |
At any time: Withhold IBRANCE until recovery to Grade ≤ 2 Resume at next lower dose. |
Grade 4a | At any time: Withhold IBRANCE until recovery to Grade ≤ 2. Resume at next lower dose. |
Grading according to CTCAE 4.0
IBRANCE dose modification and management – Non-haematological toxicities1
CTCAE Grade | Dose Modifications |
---|---|
Grade 1 or 2 | No dose adjustment is required. |
Grade ≥ 3 non-haematological toxicity (if persisting despite medical treatment) |
Withhold until symptoms resolve to:
|
Grading according to CTCAE 4.0
The list below outlines some useful management tips for both you and your patients to help prevent, identify and manage possible adverse events (AEs) with IBRANCE†.
Please note this is not an exhaustive list of treatment related AEs. Please refer to the IBRANCE SmPC for full safety profile information and guidance on the management of treatment related adverse events.
If necessary, nausea and vomiting can be treated with an anti-emetic as appropriate.9
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 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
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
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.
Footnotes:
*Most frequent (≥20%) AEs of any grade observed across the PALOMA clinical trial programme
† Preferred terms (PTs) are listed according to MedDRA 17.1.
INFECTIONS includes all PTs that are part of the System Organ Class Infections and infestations.
NEUTROPENIA includes the following PTs: Neutropenia; Neutrophil count decreased.
LEUKOPENIA includes the following PTs: Leukopenia; White blood cell count decreased.
ANAEMIA includes the following PTs: Anaemia, Haemoglobin decreased, Haematocrit decreased.
THROMBOCYTOPENIA includes the following PTs: Thrombocytopenia, Platelet count decreased.
STOMATITIS includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
For the most up-to-date safety profile information, please refer to the full IBRANCE® Summary of Product Characteristics.
Abbreviations
AEs; Adverse Events, ANC; Absolute Neutrophil Counts, CTCAE; Common Terminology Criteria for Adverse Events, DVT; Deep Vein Thrombosis, ILD; Interstitial Lung Disease PE; Pulmonary Embolism, LLN; Lower Limits of Normal, VTE; Venous Thromboembolic Event
References
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search
for MHRA Yellow Card in Google Play or Apple App Store
Adverse events should also be reported to Pfizer Medical Information on 01304 616161
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