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DosingDosingIBRANCE® Dosing
 
Monitoring Requirements
SafetySafetyIBRANCE® Safety ProfileNeutropeniaAdverse Event ManagementClinical Trials
Clinical TrialsIBRANCE® Clinical TrialsIBRANCE® PALOMA-2 Trial
 
IBRANCE® PALOMA-3 Trial
Real World EvidenceReal World EvidenceIBRANCE® Real World EvidenceIRIS (UK) StudyROIS
 
P-REALITY X
Patient ProfilesThe Ibrance® PatientPatient ProfilesAlison - >65 years with comorbiditiesBecky - Postmenopausal with bone-only diseaseSupport and ResourcesSupport and ResourcesIBRANCE Service SupportMaterials
 
Videos

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.

Title
IBRANCE® (palbociclib) is indicated for the treatment of HR+ HER2- locally advanced or metastatic breast cancer in combination with an AI, or in combination with fulvestrant in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.1
Adverse Event Management

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*                                              
If further dose reduction below 75mg/day is required, discontinue the treatment.

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.
 

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.
 

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

Table applies to all haematological adverse reactions except lymphopenia (unless associated with clinical events, e.g., opportunistic infections).ANC: Grade 1: ANC < LLN – 1,500/mm3; Grade 2: ANC 1,000 - < 1,500/mm3; Grade 3: ANC 500 ‑ < 1,000/mm3; Grade 4: ANC < 500/mm3.

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:
  • Grade ≤ 1;
  • Grade ≤ 2 (if not considered a safety risk for the patient)
Resume at the next lower dose.

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.

Management Advice for Most Frequent (≥20%) AEs of Any Grade*​​NeutropeniaAdvice for Healthcare Professionals
  • Proactively monitor full blood count, especially in the first two cycles, as neutropenia can be effectively managed by dose modification (i.e. temporary dose interruptions, cycle delays, and/or reductions)1
  • For full monitoring information, please refer to the haematological toxicities table above or the IBRANCE Summary of Product Characteristics1
Advice to Give Your Patients
  • Promptly report any signs/symptoms of infection, such as fever (temperature ≥38°C) or chills9
  • Check for fever at least once a day or as often as their Healthcare Professional recommends10
  • Avoid crowded places and do not visit people with infections, coughs or fevers, especially when white blood counts are low9
  • Maintain good hygiene; for example, patients should:10
    • Wash their hands often with soap and water, and carry hand sanitiser for times when they are unable to wash their hands
    • Wash cuts and scrapes with warm water, soap and an antiseptic until they have healed
    • Brush their teeth after meals and before they go to bed with a soft toothbrush, and use a mouth rinse that does not contain alcohol
  • Use sanitising wipes to clean surfaces and items that they touch10
  • Avoid anything that can cause cuts, scrapes or other breaks in the skin9
  • Wash raw fruit and vegetables well before eating them10
  • Do not eat raw or undercooked fish, seafood, meat, chicken or eggs, as these may contain bacteria that can cause infection9
AnaemiaAdvice for Healthcare Professionals
  • Treat underlying anaemia as appropriate
  • IBRANCE®-induced anaemia can be managed with dose delays and adjustments (i.e. temporary dose interruptions, cycle delays, and/or reductions)1
  • Please refer to the haematological toxicities table above or the IBRANCE Summary of Product Characteristics for full information1
Advice to Give Your Patients
  • Immediately report any dizziness, shortness of breath or tiredness10
  • Eat a well-balanced diet10
  • Balance rest and activities9
  • Stand up slowly, to avoid feeling dizzy; if getting up from lying down, sit for a minute before standing up10
  • Plan important activities for when they have the most energy9
  • Tell their doctor if unable to get around as they once were used to9
  • Get plenty of rest; patients should try to sleep at least 8 hours each night and might also want to take 1–2 short naps (1 hour or less) during the day10
LeukopeniaAdvice for Healthcare Professionals
  • Treat underlying leukopenia as appropriate
  • IBRANCE®-induced leukopenia can be managed with dose delays and adjustments (i.e. temporary dose interruptions, cycle delays, and/or reductions)1
  • Treat infections and symptoms of infection with standard-of-care treatment, including an anti-infective for bacterial infections as appropriate1
  • Please refer to the haematological toxicities table above or the IBRANCE Summary of Product Characteristics for full information1
Advice to Give Your Patients
  • Promptly report any signs or symptoms of infection such as fever or chills1
  • Maintain good hygiene10
    • e.g. patients should wash their hands often
  • Wash vegetables, salads and fruit well10
  • Avoid crowded places and do not visit people with infections, coughs or fevers, especially when white blood counts are low9
ThrombocytopeniaAdvice for Healthcare Professionals
  • Thrombocytopenia can be managed with dose delays and adjustments (i.e. temporary dose interruptions, cycle delays, and/or reductions)1
  • Please refer to the haematological toxicities table above or the IBRANCE Summary of Product Characteristics for full information1
Advice to Give Your Patients
  • Immediately report bleeding or bruising more easily10
  • Avoid activities that might lead to injury10
  • Protect skin from cuts, scrapes, and sharp objects10 — e.g. use an electric razor, not a blade, for shaving10
  • Avoid medications that interfere with platelets being able to form clots e.g. NSAIDs10
InfectionAdvice for Healthcare Professionals
  • Treat infections and symptoms of infection with standard-of-care treatment
  • Including an anti-infective for bacterial infections as appropriate.1
Advice to Give Your Patients
  • Promptly report any signs or symptoms of infection1
    • Such as fever or chills
  • Maintain good hygiene10
    • e.g. patients should wash their hands often
  • Wash vegetables, salads and fruit well10
  • Avoid crowded places, and do not visit people with infections, coughs, or fevers9
AlopeciaAdvice to Give Your Patients9-11
  • Use gentle hair products, such as baby shampoos
  • Be gentle when brushing and washing hair, and use a wide-toothed comb
  • Avoid too much hair brushing or pulling (braids or ponytails)
  • Avoid using hairdryers, curling tongs and curlers and, ideally, pat your hair dry
  • Wear a hat or scarf outside to keep warm
  • Wear cotton items on the scalp because they tend to stay on better than nylon or polyester
  • Use sunscreen, sunblock or a hat to protect the scalp from the sun
  • Wear a hairnet while sleeping, or sleep on a satin pillowcase
  • Avoid perms and dyes for the first few months of new hair growth, to prevent breakage
DiarrhoeaAdvice for Healthcare Professionals
  • Treat IBRANCE®-related diarrhoea with an anti-diarrhoeal as appropriate
Advice to Give Your Patients9
  • Drink plenty of clear liquid to replace lost fluids
    • e.g. water, weak tea, apple juice, peach or apricot nectar, clear broth
  • Eat small, frequent meals instead of three large ones
  • Avoid greasy foods, bran, raw fruits and vegetables, caffeine, very hot or spicy foods and milk or milk products
  • Eat foods high in potassium
    • e.g. bananas, potatoes, apricots
  • Don’t drink alcohol or use tobacco
  • When the diarrhoea starts to improve, try eating small amounts of foods that are easy to digest
    • e.g. rice, bananas, applesauce, yoghurt, mashed potatoes, low fat cottage cheese and dry toast
NauseaAdvice for Healthcare Professionals

If necessary, nausea and vomiting can be treated with an anti-emetic as appropriate.9

Advice to Give Your Patients9
  • Drink plenty of clear liquid to replace lost fluids
    • e.g. water, weak tea, apple juice, peach or apricot nectar, clear broth
  • Eat small, frequent meals instead of three large ones
  • Avoid greasy foods, bran, raw fruits and vegetables, caffeine, very hot or spicy foods and milk or milk products
  • Eat foods high in potassium
    • e.g. bananas, potatoes, apricots
  • Don’t drink alcohol or use tobacco
  • When the diarrhoea starts to improve, try eating small amounts of foods that are easy to digest
    • e.g. rice, bananas, applesauce, yoghurt, mashed potatoes, low fat cottage cheese and dry toast
FatigueAdvice to Give Your Patients9-11
  • Plan your daily routine to make sure you are getting enough rest and activity
  • Try doing light exercise each day, as this can give you more energy
  • Take short rests or breaks
  • Don’t push yourself too hard; rest when you begin to feel tired
  • Eat a well-balanced diet and drink plenty of fluids
    • Sometimes tiredness and weakness can be caused by dehydration
  • Plan important activities for when you have the most energy
  • Ask others to help with more strenuous activities, such as chores
  • Do things that are relaxing, such as listening to music or reading
  • Support groups may be able to help you manage stress and work through things that are making you tired
StomatitisAdvice to Give Your Patients12
  • Use a soft toothbrush and mild toothpaste
  • Rinse with mild bicarbonate of soda/salt rinses; swish it around and gently gargle before spitting out
  • Eat soft or pureed foods, avoid spicy, hot, crisp/crunchy, very salty or acidic foods or beverages
  • Use a straw for drinking
  • Avoid fizzy drinks, alcohol and tobacco
  • Keep mouth moist by swishing and spitting water throughout the day, sucking on ice chips or sugar-free hard sweets
  • Check mouth and tongue every day and inform HCP of any mouth sores, white spots or infections, as soon as they arise
Management of Interstitial Lung Disease (ILD)/Pneumonitis, Venous Thromboembolism and Febrile NeutropeniaILD/Pneumonitis

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

Venous Thromboembolism

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

Febrile Neutropenia

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

IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.Finn RS, et al. N Engl J Med. 2016;375:1925–36.Cristofanilli M. et al. Lancet Oncol. 2016;17:425–39.Verma S. et al. Oncologist. 2016;21:1165–75.Turner NC et al. N Engl J Med 2015; 373:209-219.Finn RS, et al. Presentation LBA1003. Presented at ASCO, 3–7 June 2022, Chicago, IL, USA;Turner NC, et al. N Engl J Med 2018;379:1926–1936American Cancer Society. Managing Cancer-related Side Effects. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects (accessed February 2022)National Cancer Institute. US Department of Health and Human Services. Chemotherapy and you. NIH publication 18-757. September 2018. https://www.cancer.gov/publications/patient-education/chemotherapy-and-you.pdf (accessed February 2022)Cancer Research UK. Side effects of cancer drugs. https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/cancer-drugs/side-effects (accessed February 2022)American Cancer Society. Mouth Sores. Available at https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/mouth-problems/mouth-sores.html. (accessed February 2022)
PP-IBR-GBR-5702. March 2024

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