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Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

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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.

Adverse Event Management

Confidence In A Treatment You Can Manage1-6

To help you prevent, identify and manage possible Adverse Events (AEs) with IBRANCE®, select an AE from the list below for useful management tips for both you and your patients.

Management Advice for Most Frequent (≥20%) AEs of Any Grade*

Neutropenia

Advice 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 IBRANCE Summary of Product Characteristics1

Advice to Give Your Patients

  • Promptly report any signs/symptoms of infection, such as fever (temperature ≥38°C) or chills7
  • Check for fever at least once a day or as often as their Healthcare Professional recommends8
  • Avoid crowded places and do not visit people with infections, coughs or fevers, especially when white blood counts are low7
  • Maintain good hygiene; for example, patients should:8
    • 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 touch8
  • Avoid anything that can cause cuts, scrapes or other breaks in the skin7
  • Wash raw fruit and vegetables well before eating them8
  • Do not eat raw or undercooked fish, seafood, meat, chicken or eggs, as these may contain bacteria that can cause infection7

Anaemia

Advice for Healthcare Professionals

  • Treat underlying anaemia as appropriate
  • IBRANCE®-induced anaemia is managed with dose delays and adjustments (i.e. temporary dose interruptions, cycle delays, and/or reductions)1

Advice to Give Your Patients

  • Immediately report any dizziness, shortness of breath or tiredness8
  • Eat a well-balanced diet8
  • Balance rest and activities7
  • Stand up slowly, to avoid feeling dizzy; if getting up from lying down, sit for a minute before standing up8
  • Plan important activities for when they have the most energy7
  • Tell their doctor if unable to get around as they once were used to7
  • 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 day8

Leukopenia

Advice for Healthcare Professionals

  • Treat underlying leukopenia as appropriate
  • IBRANCE®-induced leukopenia is 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

Advice to Give Your Patients

  • ​​​​​​​Promptly report any signs or symptoms of infection such as fever or chills1
  • Maintain good hygiene8
    • e.g. patients should wash their hands often
  • Wash vegetables, salads and fruit well8
  • Avoid crowded places and do not visit people with infections, coughs or fevers, especially when white blood counts are low7

Thrombocytopenia

Advice for Healthcare Professionals

  • Thrombocytopenia is manageable with dose delays and adjustments (i.e. temporary dose interruptions, cycle delays, and/or reductions)1

Advice to Give Your Patients

  • Immediately report bleeding or bruising more easily8
  • Avoid activities that might lead to injury8
  • Protect skin from cuts, scrapes, and sharp objects8 — e.g. use an electric razor, not a blade, for shaving8
  • Avoid medications that interfere with platelets being able to form clots e.g. NSAIDs8

Infection

Advice 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 hygiene8
    • e.g. patients should wash their hands often
  • Wash vegetables, salads and fruit well8
  • Avoid crowded places, and do not visit people with infections, coughs, or fevers7

Alopecia

Advice to Give Your Patients7-9

  • 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

Diarrhoea

Advice for Healthcare Professionals

  • Treat IBRANCE®-related diarrhoea with an anti-diarrhoeal as appropriate

Advice to Give Your Patients7

  • 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

Nausea

Advice for Healthcare Professionals

If necessary, nausea and vomiting can be treated with an anti-emetic as appropriate.7

Advice to Give Your Patients7

  • 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

Fatigue

Advice to give your Patients7-9

  • 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

Stomatitis

Advice to Give Your Patients10

  • 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 Febrile Neutropenia and Interstitial Lung Disease (ILD)/Pneumonitis

ILD/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

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


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 information, please refer to the full IBRANCE® Summary of Product Characteristics.


Abbreviations
AEs; Adverse Events, ILD; Interstitial Lung Disease
​​​​​

References
  1. IBRANCE® Summary of Product Characteristics for Great Britain click here. IBRANCE® Summary of Product Characteristics for Northern Ireland click here.
  2. Rugo HS, et al. Breast Cancer Res Treat. 2019;174:719–29.
  3. Finn RS, et al. N Engl J Med. 2016;375:1925–36.
  4. Cristofanilli M. et al. Lancet Oncol. 2016;17:425–39.
  5. Verma S. et al. Oncologist. 2016;21:1165–75.
  6. Turner NC et al. N Engl J Med 2015; 373:209-219.
  7. American Cancer Society. Managing Cancer-related Side Effects. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects (accessed February 2022)
  8. 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)
  9. 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)
  10.  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-4080. April 2022

Safety

  • IBRANCE® safety information and outcomes

  • IBRANCE® Safety Profile
  • Neutropenia

Clinical Trials

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

    ​​​​​​​PALOMA-3 Trial

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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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