g-afi-1066292_g 2013 afi breast adv bc aim patient guide

8/12/2019 G-AFI-1066292_G 2013 AFI Breast Adv BC AIM Patient Guide

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Moving Forwardin MetastaticBreast Cancer

With AFINITOR

Please see Important Safety Information on pages 52-55.

Please see accompanying Summary of Product Characteristics.

AFINITOR is a prescription medicine used to treat advanced hormone receptor-positive,HER2-negative breast cancer, along with the medicine exemestane, in postmenopausal

women who have already received certain other medicines for their cancer.


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Please see Important Safety Information on pages 52-55 .Please see accompanying Summary of Product Characteristics.

Table of ContentsSection 1 Disease Background ..............................................7

What is metastatic breast cancer (MBC)? ............................................................ 8

Can I be diagnosed with MBC if Ive never had breast cancer? ........................... 9

What does it mean that my cancer is hormone receptor-positive (HR+)? ........... 9

What are some potential treatment options for breast cancer? ........................... 10

If the breast cancer has spread and is now metastatic,

does hormonal therapy still work? ...................................................................11

What makes AFINITOR different? ........................................................................12

Why might AFINITOR be the right choice? ..........................................................14

Section 2 Starting AFINITOR Therapy .................................17

How do I take AFINITOR? ....................................................................................19

What should I avoid while taking AFINITOR?...................................................... 20

What can I do to help remember to take AFINITOR? ......................................... 22

What possible side effects should I be aware of during AFINITOR therapy? .... 24 - 31

Are there any serious side effects I should be aware of? ................................... 32

How should I store my AFINITOR tablets? ......................................................... 34

Section 3 On Treatment Support ..........................................37

What should I do if I miss a dose of AFINITOR? ........... ............ ............ ............ .. 38

How might my healthcare team manage any side effects

that I may experience while taking AFINITOR? ............................................. 40

What management approaches might my healthcare team recommend

if I experience mouth sores? .......................................................................... 42

What should I do if I experience lung or breathing problems

during treatment? ........... ............ ............. ............ ............ ............ ............ ........ 44

Will stopping or changing my AFINITOR dose impact the potential benefit

of my treatment?............................................................................................. 46

Where can I find additional support and resources? ........................................... 48

Continuing the conversation with your team ....................................................... 50

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Starting a new stage of your journeyunderstanding metastaticbreast cancer

What is metastatic breast cancer (MBC)?

Metastatic breast cancer is cancer that has moved beyond thebreast to another part of the body (such as the bones, liver, lungs,

or brain)

Metastatic tumors form from the initial

tumor found in the breast, known as

the primary tumor, and share

similar characteristics

MBC is also referred to as stage 4

breast cancer and is different from

earlier forms of the disease

It is important to understand your type of cancer so you can partnerwith your healthcare team and be prepared for the next step in your

treatment journey.Bone

Liver

Lung

Lymphnodes

Primarybreasttumor

Brain

Can I be diagnosed with MBC if Ive never

had breast cancer? Yes, it is possible to be diagnosed with MBC without a prior diagnosis

of primary breast cancer if the breast cancer metastasized, or spread

beyond the breast, before the disease was detected

It is also possible for previously diagnosed and treated breast cancer

to return, or recur, after a period of being inactive

What does it mean that my canceris hormone receptor-positive (HR+)? Hormone receptor-positive breast cancer (HR+ BC) relies on the

hormones estrogen and progesterone to live and to grow

You may have had a biopsy, a test given by your healthcare team,

to find out whether the cancer is HR+

Most breast cancers are HR+

HR+ BC is often treated with certain medicines made to help prevent

the cancer from using estrogen to grow

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What are some potential treatment options

for breast cancer?

Local Therapy

Therapy for problematic

tumors that have spread

in one part of the body

Surgery (such as

lumpectomy, mastectomy)

Radiation therapy

Systemic Therapy

Therapy given by mouth or

directly into the bloodstream

Hormonal therapy

Targeted therapy

Chemotherapy

Over time, hormonal treatment may stop working, allowing cancer to

return or spread to a new part of the body

When cancer returns or spreads to a new part of the body, this isknown as disease progression

Tumors can change, and sometimes taking just one medicine isnt

enough to treat them

If you've been living with breast cancer for a while, you may be familiar

with chemotherapy and hormonal therapy. You may have been treated

with hormonal therapy, chemotherapy, or both, earlier in your journey.

Metastatic breast cancer is different from earlier forms of disease and

may require new types of medication.

If the breast cancer has spread and is now

metastatic, does hormonal therapy still work?

Hormonal therapy is the most common treatment choice

for postmenopausal women with HR+ MBC.

Hormonal therapy adds, blocks, or removes hormones to help slow

or stop the growth of certain cancers

Synthetic hormones or other drugs may be given to block the bodys

natural hormones

Hormonal therapy is also referred to as endocrine therapy

Treatment may involve local or systemic therapies

Be open with your healthcare team about your experiences and askthem questions to learn more. Your healthcare team will work

alongside you to determine the best options for your next stage.

Know your disease,know your options

StartingAFINITOR

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AFINITOR taken with exemestane is proven effective in giving you

more time than exemestane alone without the disease progressing,or getting worse.

AFINITOR, together with another medicine called exemestane,

offers a different treatment path that can extend the benefits

of hormonal therapy alone.

AFINITOR:

Is different from both conventional hormonal therapy and

chemotherapy

Enhances hormonal therapy when hormonal therapy alone

can no longer keep disease under control

Works together with another medicine called exemestane to

target disease, and may help you stay on hormonal treatment

longer before considering other therapies

Is taken once a day by mouth, whenever it is most convenient

for you

What makes AFINITOR different?AFINITOR exemestaneplus

AFINITORa unique treatment choice

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Why might AFINITOR be the right choice?

AFINITOR taken together with exemestane

more than doubles your time

without your tumors growingor spreading,compared to justtaking exemestane alone

For patients like you with HR+, HER2 metastatic breast cancer,

In the clinical trial, AFINITOR combined with

exemestane lowered the risk of disease

progression by more than half compared to

exemestane alone*55%

7.8MONTHS

3.2MONTHS

Exemestane

AFINITOR plus exemestane

2 4 6 80

Time to disease progression (months)

*In the 18-month median follow-up analysis of the BOLERO-2 phase 3 clinical trial.

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StartingAFINITORTherapy

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Starting a new stage of metastatic breast cancer (MBC) therapy

can be challenging. As you begin treatment with AFINITOR, it is

important to be prepared, understand what to expect during therapy,

and continue to speak openly with your healthcare team.

Through education prior to starting therapy and a continued

partnership with your healthcare team, you can move confidently to

this next stage and regain control of your journey.

How do I take AFINITOR?

Just like any previous medications you have taken, it is critical that

AFINITOR is taken as your healthcare team directs. AFINITOR is a

tablet, taken by mouth once a day, and must be taken with anothermedication, exemestane.

Set a schedule and take AFINITOR at the same

time every day

Decide whether or not you will take AFINITOR

with food; for example, if you plan to take

AFINITOR with a meal or snack, you must

continue taking AFINITOR in this way

Swallow AFINITOR tablets whole with a glass

of water

By taking AFINITOR every day as directed by your healthcareteam, you have the best chance of slowing the progression of

the disease.

10 mgOnce Daily

Preparing for your treatment journey

starting AFINITOR therapy

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What can I do to help remember

to take AFINITOR?

Taking AFINITOR and exemestane consistently and regularly, as

directed by your healthcare team, will give you a stronger chance

of controlling disease progression.

The following suggestions may be helpful reminders to stayingon track with your treatment journey:

Schedule taking your medication as part of

your daily routine, like brushing your teeth

Use a treatment journal and write down

each time you take your medication

Set a daily reminder alarm with your

computer, cell phone, or watch

You may also want to consider joining a local support group and

pairing with someone else who is also undergoing treatment

for metastatic breast cancer. Please refer to pages 48-49 of

this guide for a list of resources for additional support.

Speaking with a buddy who is on a similar

journey can help you stay motivated with

your treatment plan.

Don't forgetset a schedule, stay on track

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What possible side effects should I be

aware of during AFINITOR therapy?Just like other medications that treat metastatic breast cancer,

treatment with AFINITOR may cause side effects. The side

effects that you may experience while being treated with

AFINITOR may be different from other cancer treatments.

Remember that each patients experience with AFINITOR will

be different.

Common side effects that have been reported duringAFINITOR treatment include:

Mouth ulcers and sores (also called stomatitis)

Rash

Feeling weak or tired

Diarrhea

Nausea

Loss of appetite

Weight loss

Lung or breathing problems (may be a sign of a condition

called pneumonitis)

High blood sugar levels (also called hyperglycemia)

If you experience any changes in how youfeel, reach out to your healthcare team.

Using a daily journal or log can help you note changes

in how you feel and record any potential side effects

you may experience. Partner with your healthcare

team to learn more and identify possible treatment-

related side effects early.

You may be concerned that talking with your healthcare team

about any side effects you may experience means stopping yourtreatment with AFINITOR, but that isn't always the case. Open

communication helps your healthcare team to better help you in

properly managing your side effects.

Partner with your teamlearn how to identifypossible side effects early

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What is stomatitis?Mouth sores, or stomatitis, are a very common side effect

of AFINITOR. In a clinical trial,* half of the patients that

experienced mouth sores during treatment with AFINITORsaw symptoms within the first 2 weeks of therapy.

Talk to your healthcare team to learn more. They may offer sometips to help prevent or manage mouth sores, such as:

Using a special mouthwash or mouth gel that does not contain

alcohol, peroxide, iodine, or thyme

This is an example of mild stomatitis.

Preparing for your treatment journeycommon side effects

In a clinical trial,*about 2 out of every3 patients experienced mouth sores

during therapy with AFINITOR and exemestane.

*BOLERO-2, a phase 3 clinical trial of AFINITOR, along with the medicine exemestane, for the treatment of

advanced hormone receptor-positive, HER2- negative breast cancer in postmenopausal women who have

already received certain other medicines for their cancer.

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What is noninfectious pneumonitis?

You may experience lung or breathing problems

during therapy with AFINITOR, which may

be signs of a condition called noninfectiouspneumonitis. In a clinical trial,* half of the

patients that experienced pneumonitis during

treatment with AFINITOR saw symptoms within

the first 4 months of therapy.

In a clinical trial,*about 1 out of every 6 patients

experienced pneumonitisduring therapy with AFINITOR and exemestane.

Share any changes in how you feel with your healthcare team

as soon as possible. Maintaining open communication during

your treatment journey is important to help identify and manage

potential side effects appropriately.





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How can I identify rash that may be

associated with AFINITOR treatment?

Another common side effect during AFINITOR therapy is rash.

The rash associated with treatment may appear as:

Dry or itching skin

Red elevated bumps on skin

Blackheads

Acne

Changes in metabolic and blood values

You may experience changes in your bodys normal glucose

(a type of sugar) or lipid (such as cholesterol) levels while

taking AFINITOR. These types of changes may be referred

to as metabolic events. You may also experience changes in

your blood levels (such as white blood cell and platelet counts)

while taking AFINITOR. During therapy, your healthcare team

will give you regular tests to watch for any changes in yourmetabolic and blood levels.

In a clinical trial,*about 1 out of every 3 patients

experienced rash during treatmentwith AFINITOR and exemestane.

This is an example of the type of rash that patients mayexperience while being treated with AFINITOR.





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Are there any serious side effects

I should be aware of?

Serious side effects may occur, including some that could

be life-threatening. Immediately report any bothersome side

effects or changes in how you feel to your healthcare team.

Speak to your healthcare team immediately ifyou experience any of the following:

Lung or breathing problems, especially cough,

coughing up blood, chest pain, or shortness ofbreath

Fever, chills, or any other sign you think may

be from infection

Swelling of the feet or ankles, blood in your

urine, vomiting, nausea, or diarrhea; these

could be signs of developing kidney failure

Your healthcare team will do tests to check

your kidney function throughout your

treatment with AFINITOR

Stay in touch with your healthcare teamreport serious side effectsimmediately

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How should I store my AFINITOR tablets?

Proper storage of your AFINITOR tablets is important. Following

storage instructions and taking AFINITOR as directed gives

you the best chance to control disease progression withAFINITOR treatment.

AFINITOR should be stored and handled carefully; be sure you:

Store in the original package; this will help protect your medication

from light and moisture

Use scissors to open the foil package just before taking your tablet

Do not store above 25C

Do not take AFINITOR after the expiry date noted on the carton

and blister foil; throw away all AFINITOR tablets that are out of

date or no longer needed

Do not use any pack that appears damaged

To protect your medicationfollow storage instructions

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OnTreatmentSupport

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Using a calendar or a daily reminder may help

keep you from missing an AFINITOR dose.

What should I do if I miss a dose of

AFINITOR?

Take your next dose as scheduled at your usual time the

next day

Do not take two doses to make up for a missed dose

Call your healthcare team if you are unsure or have

additional questions

It is very important to maintain a consistent schedule when taking

AFINITOR and to take your medication as prescribed. If you domiss a dose:

Remember, set a schedule and make taking your AFINITOR tabletspart of your daily routine.

Be sure to speak with your healthcare team before starting any newmedications. Please refer to pages 18-23 for important reminders for

your treatment journey with AFINITOR.

Continuing forward with AFINITOR

on treatment support

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How might my healthcare team manage

any side effects that I may experience

while taking AFINITOR?

Your healthcare team has many approaches to help you manage

side effects and to stay on therapy for as long as possible. The

approach used depends on the type of side effect as well as

the grade (the degree of severity).

Often, managing side effects is needed so you can get themost possible benefit from your treatment.

Your healthcare team may use one of the following approachesto help you best manage possible side effects :

Temporary break in taking AFINITOR until your side effect

gets better

Temporary change to a lower AFINITOR dose until your side

effect gets better

Add another prescription medicine

Recommend a nonprescription medicine

Review the list of common possible side effects on pages 24-25 of

this guide and speak with your healthcare team to learn more about

the management strategies for each.

It is important to remember that dose changes

and management of side effects are part of all

cancer therapies.

Possible approachesside effect management

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What management approaches might my

healthcare team recommend if I experience

mouth sores?

During treatment, some patients may experience mouth sores,

also called stomatitis, a very common side effect of AFINITOR.

In a clinical trial,*half of the patients that experienced

mouth sores during treatment with AFINITOR saw

symptoms within the first 2 weeks of therapy.

Products containing alcohol, peroxide, iodine, or thyme

may worsen mouth sores. Talk to your healthcare team

to learn more about ways to help improve symptoms

of stomatitis.

Depending on the type of mouth sores and how you arefeeling, your healthcare team may recommend the following

management approaches: Use a special mouthwash or mouth gel that does not contain

alcohol, peroxide, iodine, or thyme

Stop taking AFINITOR for a short period of time and then start

again once the mouth sores improve

Management approaches

stomatitis




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What should I do if I experience lung or

breathing problems during treatment?

If you experience lung or breathing problems while taking

AFINITOR, it may be related to a condition called noninfectiouspneumonitis. In a clinical trial,*half of the patients that

experienced pneumonitis during treatment with AFINITOR

saw symptoms within the first 4 months of therapy.

Speak to your healthcare team if you feel changes in your lungs

or breathing, including a cough, coughing up blood, chest pain, or

shortness of breath. These symptoms may be a sign of a serious

side effect.

To help manage noninfectious pneumonitis, your healthcareteam may recommend:

Treatment with a medication called acorticosteroid

A break in taking AFINITOR for a

period of time


noninfectious pneumonitis




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Will stopping or changing my AFINITOR

dose impact the potential benefit of my

treatment?

Managing side effects with dose changes is common in many

different types of cancer treatments and is an approach that

may allow patients to stay on treatment longer

Often, temporary changes in your medication dose is the best

approach to help you stay on AFINITOR for as long as possible

and get the most from your therapy

Speak with your healthcare team to learn more about changes

in your AFINITOR dose as well as other management

strategies for potential side effects

Of the patients in a clinical trial* who modified their

AFINITOR dose and resumedthe 10-mg dose, about3 out of every 4were able to do so in 2 weeks.

Dose modifications staying on yourtreatment journey




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Where can I find additional support

and resources?

In addition to this guide, Novartis offers a variety of tools and

resources to help you learn more about metastatic breast cancer

and move through your treatment journey, including programs to

help keep AFINITOR affordable.

The below list of support groups and national organizations may

also be helpful to you and your family to learn more about living

with breast cancer.

Reach out for additional supportand resources

These groups and organizations are independent from Novartis. Novartis has no control over,and is not responsible for, any information provided by these entities.

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Continue the conversation

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Open communication with your healthcare team is key to

overcoming many of the challenges you may encounter during your

journey. Use these questions to help start a conversation with yourhealthcare team and learn more about metastatic breast cancer,

your treatment journey, and therapy with AFINITOR.

How is metastatic breast cancer (MBC) dif ferent from earlierstages of the disease?

What are the possible treatment options for MBC? How havemy goals for therapy changed from my earlier treatment goals?

Why have I been prescribed AFINITOR?

How long will I need to take AFINITOR?

How will I know if the treatment is working?

questions for yourhealthcare team

seBackground

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Patients should not take AFINITOR if they are allergic to AFINITORKidney Failure:Patients taking AFINITOR may develop kidney failure.

In some people this may be severe and can even lead to death.

Important Safety Information

Disease


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52 53Please see accompanying Summary of Product Characteristics.

or to any of its ingredients. Patients should tell their healthcare

provider before taking AFINITOR if they are allergic to sirolimus

(Rapamune) or temsirolimus (Torisel).

AFINITOR can cause serious side effects, which can even lead to

death. If patients experience these side effects, they may need

to stop taking AFINITOR for a while or use a lower dose. Patients

should follow their healthcare providers instructions. Serious side

effects include:Lung or Breathing Problems: In some patients, lung or breathing

problems may be severe and can even lead to death. Patients

should tell their healthcare provider right away if they have any of

these symptoms: new or worsening cough, shortness of breath,

chest pain, difficulty breathing, or wheezing.

Infections: AFINITOR may make patients more likely to develop an

infection, such as pneumonia, sepsis, or a bacterial, fungal, or viral

infection. Viral infections may include reactivation of hepatitis B in

people who have had hepatitis B in the past. In some people these

infections may be severe and can even lead to death. Patients may

need to be treated as soon as possible. Patients should tell theirhealthcare provider right away if they have a temperature of 38.1C

or above, chills, or do not feel well. Symptoms of hepatitis B or

infection may include the following: fever, chills, skin rash, joint

pain and inflammation, tiredness, loss of appetite, nausea, pale

stool or dark urine, yellowing of the skin, or pain in the upper right

side of the stomach.

In some people this may be severe and can even lead to death.

Patients should have tests to check their kidney function before and

during their treatment with AFINITOR.

Before taking AFINITOR, tell your healthcare provider about all your

medical conditions, including if you:

Have or have had kidney problems

Have or have had liver problems

Have diabetes or high blood sugar Have high blood cholesterol levels

Have any infections

Previously had hepatitis B

Are scheduled to receive any vaccinations. You should not receive

a live vaccine or be around people who have recently received a

live vaccine during your treatment with AFINITOR. If you are not

sure about the type of vaccine, ask your healthcare provider

Have other medical conditions

Are pregnant or could become pregnant. AFINITOR can cause

harm to your unborn baby. You should use effective birth controlwhile using AFINITOR and for 8 weeks after stopping treatment

Are breast-feeding or plan to breast-feed. You and your healthcare

provider should decide if you will take AFINITOR or breast-feed.

You should not do both

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Tell your healthcare provider about all of the medicines you take,

including prescription and nonprescription medicines, vitamins, and

Common Side Effects:AFINITOR can cause mouth ulcers and sores.

Other common side effects include:

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54 55Please see accompanying Summary of Product Characteristics.

herbal supplements. Using AFINITOR with certain other medicines

can cause serious side effects. Keep a list of medicines you take

and show it to your healthcare provider when you get a new

medicine. Especially tell your healthcare provider if you take St.

Johns wort (Hypericum perforatum), medicines that weaken your

immune system (your bodys ability to fight infections and other

problems), or medicines for:

Fungal infections Bacterial infections

Tuberculosis

Seizures HIV-AIDS

Heart conditions or high

blood pressure

If you are taking any medicines for the conditions listed above,

your healthcare provider might need to prescribe a different

medicine or your dose of AFINITOR may need to be changed. Tell

your healthcare provider before you start taking any new medicine.

Infections

Feeling weak or tired

Cough, shortness of breath

Diarrhea and constipation

Rash, dry skin, and itching

Nausea and vomiting

Fever

Loss of appetite, weight loss

Swelling of arms, hands,

feet, ankles, face or other

parts of the body

Abnormal taste

Dry mouth

Inflammation of the lining of the

digestive system or lung tissue

Headache

Nosebleeds or spontaneous

bleeding or bruising

Pain in arms and legs,

mouth and throat,

back or joints

High blood cholesterol High blood glucose

High blood pressure

Difficulty sleeping

Hair loss

Muscle spasms

Feeling dizzy

Nail disorders

Tell your healthcare provider if you have any side effect that bothers youor does not go away.

These are not all the possible side effects of AFINITOR. For more

information, ask your healthcare provider or pharmacist. Call your

healthcare team for medical advice about side effects.

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Novartis Pharma AG

CH-4002 Basel Switzerland Novartis 2013 9/13 G-AFI-1066292

Please see Important Safety Information on pages 52-55.

Please see accompanying Summary of Product Characteristics.

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