Your Guide To Treatment With IBRANCE® (palbociclib) · are not listed in this guide or the Patient...

Your Guide To Treatment With IBRANCE® (palbociclib)Patient’s name:

Oncologist’s name:

Oncologist’s contact details:

Your treatment: Ibrance

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

with fulvestrant

You have got this information brochure because you are a patient who has been prescribed Ibrance intended to treat metastatic breast cancer. Read the Ibrance package leaflet: patient information which has been provided with the medication because it includes useful information.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pfizer Medical Information on 01304 616161.

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 www.mhra.gov.uk/yellowcard

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Contents

About mBC and its treatment 5

What is Ibrance and how is it taken? 6

Side effects that you may experience with Ibrance 10

Managing possible side effects with Ibrance 12

• Reduction in white and red blood cells and blood platelets

• Infections

• Hair loss

• Diarrhoea

• Nausea

• Fatigue

Recording how you feel with Ibrance 16

Your side effect diary 17

Your Ibrance full blood count reminder card 19

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About mBC and its treatment

What is mBC?Metastatic breast cancer (mBC), also known as stage IV or secondary breast cancer, occurs when your cancer has spread beyond the breast and nearby lymph nodes to other places in the body. Healthcare professionals call this metastatic breast cancer.

Since tumour cells have spread to other parts of the body, metastatic breast cancer is usually treated with therapies that treat the whole body – these are called systemic therapies. The goals of this treatment are to help control the spread of cancer in your body and maintain your quality of life.

HR+/HER2- subtypeAll breast cancers are assessed to find out their subtype. If you have been prescribed Ibrance it is because you have a subtype of mBC known as HR+/HER2-.

Every woman has the hormones oestrogen and progesterone in her body. A subtype which is HR+ means that your cancer cells may grow in response to either or both of these hormones. HR+ is the most common subtype of breast cancer and is present in over 60% of all cases. If you have this subtype you are more likely to respond to endocrine therapies (ET). Endocrine therapies add, block or remove these hormones and include medicines like aromatase inhibitors or fulvestrant.

A subtype which is HER2- means that your cancer cells have normal amounts of HER2, a protein that promotes growth of cancer cells; because of this, you are less likely to respond to therapies that act on HER2, so other treatments are used.

Introduction to this guide

If you are reading this guide it means you have been prescribed Ibrance®, in combination with another therapy, for treating your metastatic breast cancer (mBC). These therapies are described in more detail in this booklet.

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, there are several patient support groups that can offer information, as well as understanding, help and support if you need it.

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What is Ibrance and how is it taken?

Ibrance is used to treat HR+/HER2- locally advanced or metastatic breast cancer,

• in combination with an aromatase inhibitor (AI) or;

• in combination with fulvestrant in patients who have received prior endocrine therapy (ET)

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

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 take the 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

Ibrance should not be taken with products containing St John’s wort (a herbal product used to treat mild depression and anxiety). Tell your healthcare professional if you are taking or have recently taken St John’s wort

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

If you are of childbearing potential, you and/or your partner should use an effective method of contraception. Double-barrier protection is an example of an effective method, e.g. a condom and diaphragm. If you are unsure of what contraception to use, speak to your healthcare team or visit a family planning clinic for more information. Contraception should be used during therapy and for 3 weeks after stopping

Ibrance does not require any special storage conditions

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In order to help you take Ibrance correctly, there is a dosing tracker at the end of this booklet with which you can easily track the days you need to take Ibrance and your endocrine therapy.

Ibrance is taken orally once daily with food over a 4-week cycle

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.

You will also need to take your aromatase inhibitor or fulvestrant on a different schedule to Ibrance. This is shown below.

If you have been prescribed an aromatase inhibitor (AI) to take with Ibrance, e.g. letrozole, anastrozole, exemestane

Your doctor will explain what AI you are on, your dosage and how to take this. You 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.

4-week cycle of Ibrance with letrozole

If you have been prescribed Ibrance in combination with fulvestrant

In the first cycle, your doctor or nurse will give you an injection on the first day and the fifteenth day. In every cycle after this, you will only receive an injection on the first day.

4-week cycle of Ibrance with fulvestrant

4-WEEK CYCLE

IBRANCE 125 mg (once daily with food)

AI, e.g. letrozole 2.5 mg(once daily with food)

WEEK 1

7

3

3

WEEK 4

28

✘

3

WEEK 3

21

3

3

WEEK 2

14

3

3

4-WEEK CYCLE

IBRANCE 125 mg (once daily with food)

Fulvestrant 500 mg(one injection on Day 1*)

WEEK 1

7

3

3

WEEK 4

28

✘

✘

WEEK 3

21

3

✘

WEEK 2

14

3

✘

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

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Side effects that you may experience with Ibrance

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 packaging. We have outlined some of the most frequent side effects in the next few pages, and have included some advice on how to manage these.

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 frequent side effect with Ibrance is a low amount of a certain type of white blood cell called a neutrophil (this is called neutropenia). This can usually be managed effectively by your doctor or nurse. For more information on neutropenia, please see page 12.

Other very frequent side effects include:• Reduction in white blood cells

(leukopenia)• Reduction in red blood cells

(anaemia)• Reduction in blood platelets

(thrombocytopenia)• Infections • Feeling tired/fatigue • Physical weakness/

lack of strength

• Fever• Decreased appetite• Inflammation of the mouth

and lips (stomatitis)• Nausea• Vomiting• Diarrhoea• Rash• Hair thinning

Aromatase inhibitors and fulvestrant can also cause side effects. These side effects can be found in the patient information leaflets for these medicines. Please talk to your doctor or nurse for more information.

Monitoring your therapy

Your doctor will ask you to attend regular appointments to make sure that your treatment is working, to discuss how you are feeling and monitor for possible side effects.

Your doctor or nurse will test your blood before you start taking Ibrance and at the beginning of every 4-week cycle.

It is also important to have a blood test on Day 15 of the first 2 treatment cycles. If your doctor or nurse finds that you have low levels of neutrophils (neutropenia) when you are tested on Day 15, they will also test your blood on Day 22 of the same cycle.

If your blood results indicate that you have low white blood cells, your doctor may pause or adjust your Ibrance dose.

At the end of this guide, you will find an Ibrance full blood count reminder card that will help you remember and keep track of the blood test appointments scheduled by your doctor or nurse.

On this card, you or your doctor or nurse can write down the date and time of each of your appointments. It will be helpful if you can take this card with you on every visit, so that your healthcare provider can schedule your blood tests appropriately and monitor your therapy correctly.

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Managing possible side effects with Ibrance

Reductions in the amount of some blood cell types Ibrance can reduce your blood count, which is a count of the number of blood cells you have in a sample of your blood.

We have three types of blood cell:

• White cells that help you fight infections,

• Red cells that carry oxygen and help with your energy levels,

• Platelets that create blood clots to stop bleeding.

Most frequently Ibrance may cause a low neutrophil white blood cell count (this is called neutropenia).

Typically, a low white blood cell count does not cause any specific symptoms. 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. This pause in treatment does not make your treatment less effective.

Sometimes neutropenia can develop into a fever, this is called febrile neutropenia. The chances of developing this are low. Less than 2% of patients in studies developed febrile neutropenia. However, to prevent this occurring, it is still important to report any side effects and for your doctor to closely monitor your therapy, particularly your blood count.

Symptoms associated with febrile neutropenia

Contact your doctor straight away if you develop any of the following:

• Fever • Shortness of breath

• Chills • Weakness

• Cough • Pain when urinating

InfectionsIt is important to protect yourself against infection throughout your treatment. Here are some of the steps you can take:

• Report signs/symptoms of infection, such as fever or chills as soon as possible

• Avoid crowded places and minimise contact with people who might have infections, coughs or fevers, especially if your doctor tells you your white blood cell count is low

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

• Wash vegetables, salads and fruit well

Hair thinningStudies have shown that patients usually experience hair thinning with Ibrance rather than complete hair loss (alopecia). If hair thinning occurs, these tips may help:

• Use gentle hair products such as baby shampoos

• Be gentle when brushing and washing hair

• Avoid hair accessories or styles that pull on your hair too much (e.g. plaits or ponytails)

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

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

• Try a different hairstyle that covers areas of hair thinning or loss

• You might prefer to wear a wig

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Diarrhoea

If you experience diarrhoea, tell your doctor or nurse immediately. If necessary, they may decide to give you a specific treatment to treat diarrhoea. Certain foods and drinks can make diarrhoea worse or better.

Following these tips may help to alleviate the symptoms of diarrhoea:

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

• Eat small, frequent meals instead of 3 large ones

• It may help to avoid greasy foods, bran, raw fruits and vegetables, caffeine, very hot or spicy foods, milk or milk products

• It may help to eat foods high in potassium (e.g. bananas, potatoes, apricots)

• Alcohol and tobacco can worsen your symptoms so should be avoided

• When the diarrhoea starts to improve, try eating small amounts of foods that are easy to digest such as rice, bananas, apple sauce, yoghurt, mashed potatoes, low-fat cottage cheese, and dry toast

NauseaIf you’re feeling sick or are vomiting, it’s best to talk to your doctor or nurse. 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:

• Eat small, frequent meals instead of 3 large ones

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

• 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, as dehydration may contribute to nausea

• Use relaxation techniques, such as deep breathing

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

Fatigue During treatment you go through a lot, both physically and mentally. Whilst on your treatment you could experience fatigue, which can leave you feeling tired or weak. This could mean that you have to make some adjustments to your lifestyle, but it can be managed very well. There are also several things you can do which may increase your energy levels.

Here are some tips: • You may want to talk to your doctor or nurse to build a schedule

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 and 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

• You may want to ask others for help with more strenuous activities, for example 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

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Recording how you feel with Ibrance

It is important to keep track of how you feel while on treatment with Ibrance.

Always tell your doctor or nurse about any side effects that you experience. There may be additional treatments that can help with the side effects, or they may want to adjust the cancer treatment.

On the next page, you will find a side effect diary that will help you record any possible side effects that you may experience.

The side effect diary covers 1 cycle (28 days) of Ibrance treatment, 1 week per page.

Use a new diary for each week that you receive Ibrance treatment, and take the weekly sheet(s) with you when you visit your doctor or nurse. This can help to accurately assess how you are getting on and can allow your doctor or nurse to help with your therapy.

Before you start treatment, your doctor or nurse will give you instructions on how to take Ibrance with an aromatase inhibitor or fulvestrant and may also discuss potential side effects with you.

If they don’t and you would still like further information, please contact your doctor or nurse.

Your side effect diaryREGIMEN: Ibrance + (add in the name of endocrine therapy (ET) prescribed)

Week 1Date Time Side effect Severity

on a scale of 1 (mild) to 10 (severe)

How I felt this week (overall summary)




Points to discuss with my doctor

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Points to discuss with my doctor

Your Ibrance full blood count reminder card

DATE OF TEST TIME LOCATION

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NotesNotes

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Along with this booklet, you should find:

Dosing card

To help you track your treatment

Medical alert card

Please show this card to all healthcare professionals involved in yourcare and in case of side effects or any unexpected medical problems.Ensure your family and friends know to give this card to a doctor ifyou become ill.

You will need regular appointments with your doctor to:

• check how well you are responding to Ibrance treatment• talk about any issues that you may have experienced• receive ongoing support

These visits are your opportunity to ask your doctor any questionsyou may have.

Try writing a list of questions you want to ask before you go tosee your doctor.

It may help you to keep a note of any issues as you experience them.Take your list of side effects and questions to your next appointment,so you don’t forget to discuss them with your doctor or nurse.

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