YOUR GUIDE TO TREATMENT WITH IBRANCE® (PALBOCICLIB)Patient’s name:

Oncologist’s name:

Contact details:

IBRANCE regimen

with aromatase inhibitor (e.g. letrozole, anastrozole)

with fulvestrant

This brochure is intended for patients who have been prescribed IBRANCE by their doctor. Please read the package leaflet before use.

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INTRODUCTION TO THIS GUIDE

If you are reading this guide it means you have been prescribed IBRANCE, a new therapy for treating hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally advanced or metastatic breast cancer (mBC).

IBRANCE is taken in combination with hormonal (or endocrine) anticancer therapy,1 so you will have also been prescribed either an aromatase inhibitor (AI, e.g. letrozole, anastrozole) or fulvestrant as part of your treatment regimen.

The aim of this guide is to:

• provide you with information about treating mBC with IBRANCE

• explain clearly how to take IBRANCE

• help you manage possible side effects with IBRANCE

If you would like to learn more about mBC, visit www.spriddbröstcancerochdu.se. There you can find information about yout diagnosis, available treatment options and advice and support that you might find valuable. Your local patient support group can also offer understanding, help and support if you need it. Ask your contact nurse or doctor for more information.

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CONTENTS

About mBC and its treatment 4

How to take IBRANCE 5

Side effects that you may experience with IBRANCE 7

Managing possible side effects with IBRANCE 8

• Reduction in white and red blood cells and blood platelets

• Infections

• Hair loss

• Diarrhoea

• Nausea

• Feeling tired

RECORDING HOW YOU FEEL WITH IBRANCE 11

Your IBRANCE Complete Blood Count Reminder Card 14

Notes 15

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ABOUT mBC AND ITS TREATMENT

WHAT IS mBC?mBC, also known as stage IV breast cancer, occurs when your cancer has spread beyond the breast and nearby lymph nodes to other organs, like the lungs, bones, liver or brain.2 These distant cancer sites are called metastases.3

Since tumour cells have spread to other parts of the body, systemic therapy – which treats the whole body – is the mainstay of treatment. The goals of this treatment are to help control the spread of cancer in your body and maintain your quality of life.3

HR+/HER2- mBCTesting for hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status is assessed on all breast cancers.

If your subtype is HR+, your cancer cells may grow in response to either the hormone estrogen or progesterone, or both, and you are more likely to respond to endocrine therapies (ET) such as aromatase inhibitors or fulvestrant. HR+ is the most common subtype of breast cancer, representing over 60% of all cases.3,4

If your subtype is HER2-, your cancer cells have normal amounts of the growth-promoting protein HER2, and you are, therefore, less likely to respond to anti-HER2 therapies.5

BRAIN

LUNGS

BONES

LIVER

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HOW TO TAKE IBRANCE1

IBRANCE is used to treat HR+/HER2- locally advanced/mBC

• in combination with an AI

• in combination with fulvestrant in patients who have received prior ET

If you have not had the menopause, you may also be prescribed a treatment called a luteinising hormone blocker to stop the ovaries producing estrogen.

It is important that you take IBRANCE exactly as prescribed by your healthcare team. Here are a few helpful reminders:

Ensure you always take IBRANCE with food, preferably a meal

Take IBRANCE at approximately the same time every day

Swallow your IBRANCE capsules whole with a glass of water (do not chew, crush, or open them prior to swallowing). Do not ingest a capsule if it is broken, cracked or otherwise not intact

If you vomit or miss a dose, do not take an additional dose. Take your next prescribed dose as scheduled

Avoid grapefruit and grapefruit juice while taking IBRANCE as it may increase the side effects

Tell your healthcare professional if you are taking, have recently taken, or might take any other medicines, including complementary supplements like vitamins, as IBRANCE may affect the way some medicines work

This medicinal product does not require any special storage conditions.

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IBRANCE IS TAKEN ORALLY ONCE DAILY WITH FOOD OVER A 4-WEEK CYCLE1

For the first 3 weeks (21 days), you take one IBRANCE pill every day.

Then for the last week (7 days), you won’t take IBRANCE.

At the end of 4 weeks, the cycle will start over again.

IF YOU TAKE IBRANCE WITH AN AI, e.g. LETROZOLE, ANASTROZOLEYou take an AI pill every day throughout the entire 4-week cycle – even during the last week when you stop taking IBRANCE. Take the AI pill even if your healthcare team stops your treatment with IBRANCE or adjusts your IBRANCE dose.

IF YOU TAKE IBRANCE WITH FULVESTRANTYou will receive an injection from your healthcare provider on the first day of every cycle. Additionally, for the first cycle only, you will also receive a second injection on Day 15 of your therapy.

4-WEEK CYCLE

*For the first cycle only, you will also receive a fulvestrant injection on Day 15.

IBRANCE 125 mg (once daily with food)

aromatase inhibitoror

Fulvestrant 500 mg(one injection on Day 1*)

WEEK 1

7

3

33

WEEK 4

28

✘

3✘

WEEK 3

21

3

3✘

WEEK 2

14

3

3✘

6 7

• Nausea

• Vomiting

• Diarrhoea

• Rash

• Hair loss

SIDE EFFECTS THAT YOU MAY EXPERIENCE WITH IBRANCE1

Like all medicines, IBRANCE can cause side effects, although not everybody gets them. A list of side effects that could occur while taking IBRANCE can be found in the Patient Information Leaflet contained in your IBRANCE pack.*

Talk to your doctor if you experience side effects of any kind, even if they are not listed in this guide or the Patient Information Leaflet.

The most common side effect with IBRANCE is a low white blood cell count (this is called neutropenia).

Other very common side effects include:

• Reduction in red blood cells and blood platelets

• Infections

• Feeling tired

• Decreased appetite

• Inflammation of the mouth and lips (stomatitis)

MONITORING YOUR THERAPYYour doctor will ask you to attend regular visits to make sure that your treatment is working, discuss with you how you are feeling and monitor for possible side effects.

Your healthcare team will test your blood before you start taking IBRANCE and at the beginning of every 4-week cycle.

Additionally, your blood will be tested on Day 14 of the first 2 treatment cycles. If your blood results indicate that you have low white blood cells, your healthcare team may pause or adjust your IBRANCE dose.

At the end of this guide, you will find an IBRANCE Complete Blood Count Reminder Card that will help you remember and keep track of the blood test appointments your healthcare team will schedule during your IBRANCE treatment.

*For ET-related side effects, please refer to the Patient Information Leaflet of your respective ET.

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MANAGING POSSIBLE SIDE EFFECTS WITH IBRANCE*

REDUCTIONS IN WHITE AND RED BLOOD CELLS AND BLOOD PLATELETSIBRANCE can reduce your blood count, which is a count of the number of blood cells you have in a sample of your blood. Of the three types of blood cells we have (white cells help you fight infections, red cells carry oxygen and help with your energy levels, and platelets create blood clots to stop bleeding), IBRANCE most commonly may cause a low white cell blood count.1,6

Typically, a low white blood cell count does not cause any specific symptoms, and is rarely associated with fever. However, if your blood test results show that your white blood cell count is low, your doctor may pause your treatment with IBRANCE or reduce the dose of IBRANCE to help your white blood cell counts recover,1 without this compromising its efficacy.7

Contact your doctor straight away if you develop any of the following, which might be associated with a low blood cell count:1,6

• Fever

• Chills

• Weakness

INFECTIONSIt’s important to take steps to protect yourself against infection throughout your treatment:

• Promptly report signs/symptoms of infection, such as fever or chills1,6,8

• Avoid crowded places and do not visit people who might have infections, coughs or fevers, especially if your doctor tells you your white blood cell count is low6,8

• Maintain good hygiene, e.g. wash your hands often, particularly before preparing food or eating6,8

• Wash vegetables, salads and fruit well

*This section of the guide does not include management tips for all the most common side effects that you may experience with IBRANCE.

• Shortness of breath

• Bleeding

• Easy bruising

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HAIR LOSSObvious hair loss with IBRANCE is rare, although hair thinning may occur.7 If hair thinning occurs, these tips may help:6,8

• 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)

• Avoid using hair dryers, curling tongs and curlers on thinning hair, and pat your hair dry

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

DIARRHOEA

If you experience diarrhoea, tell your healthcare team immediately. They may decide to give you a specific treatment to treat diarrhoea if necessary. But also take a closer look at your diet. Certain foods and drinks can make diarrhoea worse or better. Following these tips may help to alleviate diarrhoea symptoms:6,8,9

• Drink plenty of clear liquid (e.g. water, weak tea, apple juice, 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

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NAUSEAIf you’re feeling sick or are vomiting, it’s best to talk to your healthcare team. They can give you instructions on how to deal with your symptoms or may prescribe you medication that can help. In addition to your healthcare team’s instructions, following these tips may help you feel better:6,8

• Eat small, frequent meals instead of 3 large ones

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

• Avoid fried foods, fatty foods or foods with a strong aroma

• 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

FEELING TIRED During treatment you go through a lot, both physically and mentally. This could leave you feeling tired or weak. By following these tips, you may be able to increase your energy:6,8,10

• 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

• Keep a diary. Over time you might discover patterns, for instance that you get tired after a certain activity or that your tiredness bothers you more at a certain time of the day

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RECORDING HOW YOU FEEL WITH IBRANCE

While on IBRANCE therapy, it is important to keep track of how you feel at all treatment points.

Always tell your doctor or nurse about any side effects you may be experiencing. There are supplemental treatments available that can help with the side effects – or they may want to adjust the cancer treatment.

There is also a SIDE EFFECT DIARY that will help you record any possible side effects you may experience, when they happen, and how bad they are on a scale of 1 (mild) to 10 (severe).

The SIDE EFFECT DIARY covers 1 cycle (28 days) of IBRANCE treatment – 1 week per page.

Take the weekly worksheet(s) with you when you visit your healthcare provider sas a basis for a discussion about your tretament with IBRANCE.

Before you start treatment, your healthcare team will give you instructions on how to take IBRANCE and may also discuss potential IBRANCE side effects with you.

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YOUR IBRANCE COMPLETE BLOOD COUNT REMINDER CARD

DATE OF TEST TIME

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YOUR IBRANCE COMPLETE BLOOD COUNT REMINDER CARD

DATE OF TEST TIME

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Notes

14 15

Notes

PP

-IB

R-S

WE

-03

28, F

EB

-20

20

References: 1. IBRANCE® Summary of Product Characteristics. 2. Cancer Research UK. TNM breast cancer staging. http://www.cancerresearchuk.org/about-cancer/type/breast-cancer/treatment/tnm-breast-cancer-staging. Accessed September 2016. 3. ESMO. Breast Cancer: A guide for patients. http://www. esmo.org/Patients/Patient-Guides/Breast-Cancer. Accessed September 2016. 4. American Cancer Society. Hormone therapy for breast cancer. http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-treating-hormone-therapy. Accessed 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/. Accessed September 2016. 7. Verma S, et al. Oncologist. 2016;21:1165–1175. 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. Diarrhea: cancer-related causes and how to cope. http://www.mayoclinic.org/diseases-conditions/cancer/in-depth/diarrhea/art-20044799. Accessed September 2016. 10. American Cancer Society. Managing cancer-related fatigue. http://www.cancer.org/treatment/treatmentsandsideeffects/physicalsideeffects/fatigue/seven-ways-to-managecancer-related-fatigue. Accessed September 2016.

IBRANCE (palbociklib), hard capsules, 75 mg, 100 mg, 125 mg. Read the information in the package leaflet of the medical product.IBRANCE is used to treat patients with certain types of breast cancer (hormone receptor-positive, human epidermal growth factor receptor 2-negative) which have spread beyond the original tumor and/or other organs. It is given together with aromatase inhibitors or fulvestrant, which is used as hormonal anticancer therapies.

Do not take IBRANCE if you are allergic to palbociclib or any of the other ingredients of this medicine. Use of preparations containing St. John´s Wort should be avoided while you are taking IBRANCE. You should not use IBRANCE if you are pregnant. Tell your doctor or nurse if you experience signs or symptoms of any infection, such as chills or fever. IBRANCE may reduce the number of your white blood cells and weaken your immune system. Therefore, you may be at greater risk of getting an infection during your treatment. IBRANCE may cause severe or life-threatening inflammation of the lungs. Tell your doctor or nurse immediately if you are experience new or worsening symptoms such as difficulty breathing, shortness of breath, dry cough or chest pain. You will have regular blood tests during treatment to check wheatear IBRANCE affects your blood cells (white blood cells, red blood cells and platelets). Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. IBRANCE may affect the way some other medicines work.

This leaflet was last revised in Nov 2019Pfizer Innovations AB, Phone: 08-550 52 000 www.pfizer.se This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 in the package leaflet for how to report side effects.

Pfizer Innovations AB 191 90 SollentunaTel 08-550 520 00 www.pfizer.se