PATIENT GUIDE FOR IBRANCE TREATMENT® (PALBOCICLIB)

Patient’s name:

Treating physician:

Contact nurse/patient navigator:

IBRANCE treatment

with aromatase inhibitors (e.g. letrozole or anastrozole)

with fulvestrant

This brochure is intended for patients that have been prescribed IBRANCE by their physician. Read the package leaflet for use instructions.

2 3

INTRODUCTION

If you are reading this guide, you have been prescribed IBRANCE, a treatment for hormone receptor-positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) locally advanced or advanced (metastatic) breast cancer that has spread outside the original tumour and/or to other organs.

IBRANCE is taken in combination with a hormonal therapy (endocrine therapy) to treat cancer,1. In connection with this treatment, you have also been prescribed an aromatase inhibitor (e.g., letrozole or anastrozole) or fulvestrant.

In this guide, we hope to:

• provide you with information on how IBRANCE is used to treat metastatic breast cancer

• clearly explain how you will take IBRANCE

• help you manage any potential side effects caused by IBRANCE treatment

You can also find more information on IBRANCE on the pre-approved patient website, www.ibrancepatient.se.

If you would like to read more about metastatic breast cancer, follow this link: www.spriddbröstcancerochdu.se. There, you will find information about your diagnosis, treatment options available to you as well as advice and support that can help you through this process. You can also find information about living with advanced breast cancer at: www.patientnavigator.se. There, you will find answers to some of the most commonly asked questions with links to valuable information, covering a range of areas that are relevant to you in your treatment path.

There is also an app available called EmotionSpace that has been developed to help you manage the emotional impact of this process. EmotionSpace is an app designed to provide patients with advanced breast cancer with a safe space to talk about how they are feeling and, if desired, to ask others for support. You can find more information at www.emotionspace.se.

If you are in need of more support, many cities and regions have a local patient association. Talk with your contact nurse or doctor for more information.

2 3

CONTENTS

Information on advanced breast cancer and treatment .........................4

How to take IBRANCE .....................................................................................5

Possible side effects when taking IBRANCE ..............................................7

How to manage side effects caused by IBRANCE ...................................8

• Reduced red and white blood cell counts and platelet counts.

• Infection

• Hair loss

• Diarrhoea

• Nausea

• Fatigue

Take note of how you feel when taking Ibrance ...................................... 11

Blood test reminder card during Ibrance treatment .............................. 12

Notes ................................................................................................................. 14

4 5

INFORMATION ON ADVANCED BREAST CANCER AND TREATMENT

WHAT IS ADVANCED BREAST CANCER?Advanced breast cancer, also known as stage IV breast cancer, is breast cancer that has spread beyond the breast tissue and adjacent lymph nodes to organs in other parts of the body, e.g. the lungs, liver or brain.2 When this occurs, the cancer is described as metastatic.3

Since tumour cells have spread to other parts of the body, systemic treatment—whole-body treatment—is the basis for the treatment. The goal of this treatment is to help control the spread of cancer within the body and maintain a good quality of life.3

HR+/HER2- mBCWhen any type of breast cancer is detected, it is necessary to perform tests for hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2).

If you have the subtype HR+ (hormone receptor positive), cancer cells can multiply in the presence of the hormone oestrogen or progesterone or both, and the likelihood that you will respond favourably to endocrine treatment (hormone therapy) such as aromatase inhibitors or fulvestrant is much greater. HR+ is the most common subtype of breast cancer and accounts for over 70% of all cases.3,4

If you have subtype HER2– the cancer cells have a normal amount of the growth-promoting protein HER2 making it less likely that you will respond to treatment for HER2.5

BRAIN

LUNGS

SKELETAL SYSTEM

LIVER

4 5

TAKING IBRANCE 1

IBRANCE is used to treat HR+/HER2– locally advanced metastatic breast cancer

• in combination with an aromatase inhibitor

• in combination with fulvestrant for patients who have previously received hormone therapy

Pre-menopausal patients may also be given a drug called an luteinizing hormone blocker to halt oestrogen production in the ovaries.

It is important that you take IBRANCE exactly as indicated by your health care provider. Keep the following items in mind when taking IBRANCE:

Always take IBRANCE with food, preferably at mealtimes.

Take IBRANCE at approximately the same time each day.

Swallow the capsules whole with a glass of water (do not chew, crush or open the capsules before taking the drug). Do not take a capsule that is broken, cracked or damaged in any other way.

If you vomit or forget to take a dose, do not take an extra dose. Simply take the next dose according to schedule.

Avoid grapefruit and grapefruit juice when taking IBRANCE as this can increase side effects. Completely avoid any product containing St. John’s wort.

Talk with your health care provider about drugs (including dietary supplements such as vitamins) you are currently taking, have recently taken or that you may take in the near future, as IBRANCE can have an effect on the function of other drugs.

There are no special storage instructions for this drug.

LUNGS

LIVER

6 7

IBRANCE IS TAKEN ONCE DAILY WITH A MEAL IN A 4-WEEK CYCLE 1

The first 3 weeks (21 days) you take one IBRANCE capsule per day.

The last week of the cycle (7 days) you take no IBRANCE treatment.

After 4 weeks has passed, the first cycle is complete, and the next cycle begins.

IF YOU TAKE IBRANCE WITH AN AROMATASE INHIBITOR e.g. LETROZOLE OR ANASTROZOLEYou will take one aromatase inhibitor tablet for the entire 28-day cycle, i.e., even during the last week of the cycle when you do not take IBRANCE. Continue this treatment even if your doctor interrupts your IBRANCE treatment or changes the dosage.

IF YOU TAKE IBRANCE WITH FULVESTRANTYou will receive an injection on the first day of each cycle. During the first cycle, you will receive an extra injection on day 15.

28-DAY CYCLE

*During the first treatment cycle, you will also have a fulvestrant injection on day 15.

IBRANCE 125 mg (once daily with a meal)

Aromatase inhibitor or

fulvestrant 500 mg (one injection daily 1*)

WEEK 1

7

3

33

WEEK 4

28

✘

3✘

WEEK 3

21

3

3✘

WEEK 2

14

3

3✘

6 7

SIDE EFFECTS YOU MAY EXPERIENCE WHEN TAKING IBRANCE1

Like all drugs, IBRANCE may cause side effects, but not everyone will experience them. The package leaflet included with the product packaging contains a list of the side effects that you may experience when taking IBRANCE.*

Talk with your doctor or contact nurse/patient navigator if you experience side effects of any kind, even if they are not explicitly described in this guide or in the package leaflet.

The most common side effect of IBRANCE treatment is a low white blood cell count (neutropenia).

Other side effects that may occur include:

• Reduced red blood cell counts and platelet counts

• Infection

• Fatigue

• Decreased appetite

• Inflammation of the mouth and lips (stomatitis)

• Nausea

• Vomiting

• Diarrhoea

• Rash

• Hair loss

FOLLOW-UPS DURING TREATMENTYour doctor will ask you to come in for regular follow-ups to determine how well the treatment is working. You will talk with your doctor about how you have been feeling and whether you have experienced any side effects.

A blood test will be performed before you start IBRANCE as well as once at the start of every 4-week cycle. You will also have blood tests performed on day 15 of the first two treatment cycles. If the blood tests show that you have a low white blood cell count, you may need to interrupt treatment or change your IBRANCE dosage.

At the end of this guide, you will find a reminder card to help you keep track of your blood examinations that might make things a little easier for you.

*Side effects related to hormone therapy are indicated in the package leaflet for the respective hormone therapy drugs.

8 9

HOW TO MANAGE ANY POTENTIAL SIDE EFFECTS WHEN TAKING IBRANCE*

REDUCED NUMBER OF RED AND WHITE BLOOD CELL COUNTS AND PLATELET COUNTSIBRANCE may reduce your blood counts. Your blood contains three types of blood cells (white, which fight infection, red, which transport oxygen and help maintain your energy level, and platelets, which form clots to stop bleeding). The most common side effect associated with IBRANCE treatment is a reduced white blood cell count .1,6

Usually, a low white blood cell count does not give any specific symptoms and is seldom combined with a fever. If your blood tests show that you have a low white blood cell count, your doctor may interrupt your IBRANCE treatment or reduce the dose so that your white blood cell count is able to recover,1 without diminishing the effectiveness of the drug.7

Contact your doctor immediately if you experience any of the following symptoms as they may be a sign of a low white blood cell count: 1,6

• Fever

• Chills

• Weakness

INFECTIONIt is important that you take measures to protect yourself from infection over the entire course of treatment:

• Contact your healthcare provider immediately if you show any signs or symptoms of infection, such as fever or chills 1,6,8

• Avoid large public gatherings and refrain from visiting persons who may be ill, have a cough or fever. This is especially true if your doctor informs you that you have a low white blood cell count 6,8

• Maintain good hygiene practices, e.g., wash your hands frequently, especially before cooking or eating 6,8

• Wash vegetables, salad greens and fruit thoroughly

*This section of the guide does not provide guidelines for handling all the potential side effects associated with IBRANCE treatment.

• Breathlessness

• Bleeding

• Easy bruising

8 9

HAIR LOSSVisible hair loss as a result of IBRANCE treatment is uncommon, but your hair may become thinner.7 If you notice that your hair is getting thinner, you can: 6,8

• Use milder products, e.g.,. baby shampoo

• Brush and wash your hair carefully

• Avoid brushing or wearing your hair up too often (braids or ponytails)

• Avoid hair dryers, curling irons and curlers and dry your hair by patting dry with a towel

• Wear a hat or head scarf outdoors to minimise the loss of body heat

DIARRHOEA

If you experience diarrhoea, talk with your health care provider immediately. Your physician may be able to prescribe you a special treatment to alleviate symptoms of diarrhoea. You should also take a closer look at the foods you are eating. Certain foods and beverages can aggravate or improve your diarrhoea symptoms. Tips to help alleviate your symptoms: 6,8,9

• Drink plenty of clear liquids (e.g., water, weak tea, apple juice, clear broth) to keep yourself well hydrated

• Eat smaller portions more frequently rather than three large meals

• Avoid fatty foods, foods that are high in fibre, raw fruits and vegetables, caffeine, spicy or heavily seasoned foods, milk and other dairy products

• Eat foods that are high in potassium (e.g., bananas, potatoes, apricots)

• Do not drink alcohol or smoke

• When your diarrhoea symptoms start to improve, try to introduce small portions of foods that are easy to digest, e.g., rice, bananas, apple sauce, yoghurt, mashed potatoes, low-fat cottage cheese and toast

10 11

NAUSEAIf you experience nausea or vomiting, you should talk with your health care team. They can give you advice on how to best manage your symptoms or prescribe drugs that can help. The following tips may also help you feel a little better: 6,8

• Eat smaller portions more frequently rather than three large meals

• Try to eat calorie-rich foods that are easy to get down (desserts, ice cream, yoghurt etc.) several times a day

• Avoid fried foods, fatty foods and foods with a strong aroma/flavour

• Eat gentle foods, e.g., toast or crackers

• Drink plenty of water throughout the day as dehydration can contribute to nausea

• Take time for relaxation exercises, e.g. deep breathing

• When you feel nauseous, try to engage in activities that take your mind elsewhere, such as listening to music, watching TV, or visiting with friends

FATIGUE During treatment, you will be subject to a great deal of stress, both mentally and physically. You may feel tired and weak. The following tips can help you increase your energy level: 6,8,10

• Daily light exercise can give you more energy

• Take short rest breaks or longer if needed

• Avoid overexertion, take a break before you feel worn out

• Eat a well-balanced diet and drink plenty of fluids. Tiredness and fatigue can sometimes be caused by dehydration

• Plan important activities at times of the day when you have the most energy

• Ask others for help with household chores

• Take time for relaxing activities, such as reading or listening to music

• Joining a support group can help you manage stress and to better understand what it is that makes you so tired.

• Keep a diary. Over time, you may discover that there is a pattern to your fatigue, e.g., certain activities make you tired, or that your level of fatigue is worse at certain times of the day

10 11

NOTE HOW YOU FEEL WHEN TAKING IBRANCE

When taking IBRANCE, it is important to always pay attention to how you feel.

Always talk to your doctor or nurse if you experience any side effects. There are drugs available to help counteract side effects – or it may be possible to change your cancer treatment.

There is also a side effects diary where you can write a description of all the side effects you experience, when you get them, and how intense they are on a scale of 1 (mild) to 10 (severe).

THE SIDE EFFECTS DIARY covers one IBRANCE treatment cycle (4 weeks), one week per page. You might like to take the diary with you on doctor’s visits to help you talk about side effects you are experiencing during you IBRANCE treatment.

Before beginning treatment, you will receive instructions from your healthcare team on how to take IBRANCE and they can also discuss the potential side effects of IBRANCE treatment with you.

12 13

BLOOD TEST REMINDER CARD DURING IBRANCE TREATMENT

TEST DATE AT

12 13

BLOOD TEST REMINDER CARD DURING IBRANCE TREATMENT

TEST DATE AT

14 15

Notes

14 15

Notes

Literature: 1. IBRANCE product summary. 2. Cancer Research UK. TNM breast cancer staging. http://www.cancerresearchuk.org/about-cancer/type/breast-cancer/treatment/tnm-breast-cancer-staging. Published September 2016. 3. ESMO. Breast Cancer. A guide for patients. http://www.esmo.org/Patients/Patient-Guides/Breast-Cancer. Published September 2016. 4. American Cancer Society Hormone therapy for breast cancer. http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-hormone-therapy. Published September 2016 5. Onitilo A, et al. Breast Cancer Subtypes Based on ER/PR and Her2 Expression: Comparison of Clinicopathologic Features and Survival. Clinical Medicine & Research 2009;7:4-13. 6. Cancer Research UK. Breast cancer. http://www.cancerresearchuk.org/about-cancer/type/breast-cancer/. Published September 2016. 7. Verma S, et al. Oncologist. 1 July 2016. E-publ. Prior to printing. 8. American Cancer Society. Caring for the patient with cancer at home: a guide for patients and families. http://www.cancer.org/treatment/treatmentsandsideeffects/physicalsideeffects/dealingwithsymptomsathome. September 2016. 9. Mayo Clinic. Diarrhoea: cancer-related causes and how to cope. http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/diarrhea/art-20044799. Published September 2016 10. American Cancer Society. Managing cancer-related fatigue. http://www.cancer.org/treatment/treatmentsandsideeffects/physicalsideeffects/fatigue/seven-ways-to-managecancer-related-fatigue. Published September 2016

Pfizer 191 90 SollentunaTel +46 08-550 520 00 www.pfizer.se

IBRANCE (palbociclib), 75 mg, 100 mg, 125 mg. Read drug information in the package leaflet.IBRANCE is used to treat patients with a specific type of breast cancer (hormone receptor-positive/human epidermal growth factor receptor 2 negative) that has spread outside the original tumour and/or to other organs. Treatment is given together with aromatase inhibitors or Fulvestrant, which are hormone therapies used to treat cancer.

IBRANCE should not be used to treat those with a hypersensitivity to palbociclib or to any other ingredient in this drug. Use of products containing St. John’s wort should be avoided when taking IBRANCE. IBRANCE may not be used during pregnancy.

Talk with your doctor or nurse if you notice any signs or symptoms of an infection, for example, chills or fever. IBRANCE may decrease your white blood cell count and weaken your immune system, therefore, the risk of infection is increased during IBRANCE treatment. Blood tests will be done regularly during your treatment to determine whether IBRANCE is having an impact on your blood counts (white and red blood cells and platelets). Please tell your doctor or pharmacy staff if you are taking, have recently taken, or may take any other drugs, including non-prescription drugs. IBRANCE can have an effect on the function of other drugs. Date of last review of package leaflet July 2018.Pfizer Innovations AB, Telephone +46 08-550 52 000

 This drug is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects can be found in the end of the section, Side effects in the patient information leaflet.

PP

-IB

R-S

WE

-018

9, S

epte

mb

er 2

018