Adverse event management

Click here for downloadable Neutropenia Monitoring and Dose Management Guide

Haematologic toxicities

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

Patients should have an absolute neutrophil count (ANC) ≥1000/mm3 and platelet counts ≥ 50,000/mm3 before they can receive treatment with IBRANCE®1. CBC monitoring should be performed at the beginning of each cycle for the first 6 cycles and also on Day 15 for the first 2 cycles.  Beyond 6 cycles, CBC tests can be carried out every 3 months unless the patient has experienced grade 3 or 4 neutropenia whereby monthly CBC tests are recommended. In addition to this guidance CBC should be monitored as clinically indicated. The dose of IBRANCE® may need to be modified depending on the results of the CBC tests1.

aem_haematologic_toxicities

 

Non-haematologic toxicities

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

ibrance_adverse_events_management

ILD =  Interstitial Lung Disease

Reference​

  1. IBRANCE® Summary of Product Characteristics. ​

 

PP-IBR-IRL-0288
Date of preparation: March 2020

Management tips​

​To help you prevent, identify and manage possible adverse events with IBRANCE®, please see below list for useful management tips for both you and your patients:*​​

 

Neutropenia​

For the HCP​

  • Proactively monitor complete blood count (CBC) as neutropenia can be effectively managed by dose modification​ without the need for growth factors (see the haematologic toxicities management algorithm in the IBRANCE® Dosing Guide)1​

  • Treat cases of febrile neutropenia (~ 2% of patients exposed to Ibrance®) with standard of care treatment (including anti-infective) as appropriate​​

For the patient​

  • Promptly report any signs/symptoms of infection, such as fever or chills1-3​

  • Avoid crowded places, and do not visit people with infections, coughs or fevers, especially when absolute neutrophil count and white blood counts are low2,3​

  • Maintain good hygiene (e.g. patients should wash their hands often)2,3​

 

​Anaemia​

For the HCP​

  • Treat underlying anaemia as appropriate​

  •  IBRANCE®-induced anaemia is manageable with dose delays and adjustment (see the haematologic toxicities management algorithm in the IBRANCE® Dosing Guide)1

  • Standard-of-care treatment should be considered​

​For the patient​

  • Immediately report any dizziness, shortness of breath, or weakness2-3​

  • Eat a well-balanced diet2,3​

  • Balance rest and activities2,3​

 

Thrombocytopenia

For the HCP​

  • Thrombocytopenia is manageable with dose delays and adjustment (see the haematologic toxicities management algorithm in the IBRANCE® Dosing Guide)1

For the patient​

  • Immediately report bleeding or bruising more easily2-3​

  • Avoid activities that might lead to injury2

  • Protect skin from cuts, scrapes, and sharp objects (e.g. use an electric razor, not a blade, for shaving)2

Infection

For the HCP​

  • Treat infections and symptoms of infection with standard-of-care treatment, including an anti-infective for bacterial infections as appropriate​

For the patient​

  • Promptly report any signs or symptoms of infection, such as fever or chills1,3

  • Avoid crowded places, and do not visit people with infections, coughs, or fevers2,3​

  • Maintain good hygiene (e.g. patients should wash their hands often)2,3​

 

​Alopecia (hair thinning)​

For the patient4

  • Use gentle hair products such as baby shampoos​

  • Be gentle when brushing and washing hair​

  • Avoid too much hair brushing or pulling (braids or ponytails)​

  • Stay away from heat (blow-dryers or curling irons)​

  • Wear a hat or scarf outside to reduce loss of body heat​

 

Diarrhoea

For the HCP​

  • Treat IBRANCE®-related diarrhoea with standard-of-care treatment, including an antidiarrhoeal as appropriate​

For the patient4​

  • Drink plenty of clear liquid (e.g. water, weak tea, apple juice, peach or apricot nectar, clear broth) to replace lost fluids​

  • Eat small, frequent meals instead of 3 large ones​

  • Avoid greasy foods, bran, raw fruits and vegetables, caffeine, very hot or spicy foods, 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 such as rice, bananas, applesauce, yogurt, mashed potatoes, low fat cottage cheese, and dry toast​

 

Nausea 

For the HCP​

  • Treat infections and symptoms of infection with standard-of-care treatment, including an anti-infective for bacterial infections as appropriate​

For the patient4​

  • Eat small, frequent meals instead of 3 large ones​

  • Try foods high in calories that are easy to eat (pudding, ice cream, yogurt, etc.) several times a day​

  • Avoid fried foods, fatty foods or foods with a strong smell​

  • Eat bland foods, such as dry toast and crackers​

  • Sip water throughout the day, since dehydration may contribute to nausea​

  • Use relaxation techniques, such as deep breathing​

  • When experiencing nausea, use distractions such as music, television, or company​

 

Fatigue

For the patient 2-4​

  • Build a schedule to make sure patients 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 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​​

​If you would like more detailed information on the incidence, classification and characterisation of the above adverse events, please ask a Pfizer representative for a copy of the “Practical guide to treatment with IBRANCE®”.​

*This is a list of adverse events (AEs) of interest. The full list of AEs reported with IBRANCE® can be found in the Summary of Product Characteristics.

References​

  1. IBRANCE® Summary of Product Characteristics.​
  2. Cancer Research UK. Breast cancer. https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatmen... Accessed March 2020.​
  3. American Cancer Society. Caring for the patient with cancer at home:​ a guide for patients and families.https://www.cancer.org/content/dam/cancer-org/cancer-control/en/booklets....        Accessed March 2020.​
  4. National Cancer Institute. Chemotherapy and you.  https://www.cancer.gov/publications/patient-education/chemotherapy-and-y... . Accessed March 2020.​

 

PP-IBR-IRL-0288
Date of preparation: March 2020

▼ 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.