G-AFI-1066292 - G 2013 AFI Breast Adv BC AIM Patient Guide

Moving Forward in Metastatic Breast Cancer
With AFINITOR
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.
Please see Important Safety Information on pages 52-55. Please see accompanying Summary of Product Characteristics.
Disease Background
Table of Contents
Section 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 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
Starting AFINITOR
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
Continuing the conversation with your team........................................................ 50
On Treatment Support
Disease Background
This guide, together with conversations with your healthcare team, can help you learn more about Metastatic Breast Cancer (MBC) and the benefits of AFINITOR treatment.
Remember to always be open with your healthcare team about any questions, thoughts, or concerns. You are the central member of your team. Asking questions and talking openly about your concerns will help you understand your options and be confident about your decisions. By partnering with your healthcare team, you can help make sure you are empowered to take control of the next stage of your treatment. Living with metastatic breast cancer (MBC) is a journeya journey filled with many different emotions. You may feel anxious, restless, or uncertain of what to do. While many women have MBC, your journey and your challenges are unique to you and your life.
Starting AFINITOR
It can be overwhelming, but know that you arent alone.
Disease Background
Disease Background
Starting AFINITOR On Treatment Support
Disease Background
Starting a new stage of your journey
understanding metastatic breast cancer

What is metastatic breast cancer (MBC)?
Metastatic breast cancer is cancer that has moved beyond the
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
breast to another part of the body (such as the bones, liver, lungs, or brain)
Metastatic tumors form from the initial
What does it mean that my cancer is hormone receptor-positive (HR+)?

Hormone receptor-positive breast cancer (HR+ BC) relies on the
Starting AFINITOR
tumor found in the breast, known as the primary tumor, and share similar characteristics
MBC is also referred to as stage 4
Brain
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
breast cancer and is different from earlier forms of the disease
Lymph nodes Lung
the cancer from using estrogen to grow
Primary breast tumor
Bone
It is important to understand your type of cancer so you can partner with your healthcare team and be prepared for the next step in your treatment journey.
Liver
Disease Background
Know your disease,
know your options

What are some potential treatment options for breast cancer?
Treatment may involve local or systemic therapies
If the breast cancer has spread and is now metastatic, does hormonal therapy still work?
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 is
Local Therapy
Therapy for problematic tumors that have spread in one part of the body S urgery (such as lumpectomy, mastectomy) Radiation therapy
Systemic Therapy
Therapy given by mouth or directly into the bloodstream Hormonal therapy Targeted therapy Chemotherapy
known as disease progression
Starting AFINITOR
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.
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
Be open with your healthcare team about your experiences and ask them questions to learn more. Your healthcare team will work alongside you to determine the best options for your next stage.
natural hormones
Hormonal therapy is also referred to as endocrine therapy
10
11
Disease Background
AFINITOR
a unique treatment choice

What makes AFINITOR different?
AFINITOR, together with another medicine called exemestane, offers a different treatment path that can extend the benefits of hormonal therapy alone.
AFINITOR plus exemestane
Starting AFINITOR
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
AFINITOR taken with exemestane is proven effective in giving you more time than exemestane alone without the disease progressing, or getting worse.
12
13
Disease Background
Why might AFINITOR be the right choice?

For patients like you with HR+, HER2 metastatic breast cancer,
without your tumors growing or spreading, compared to just

taking exemestane alone
AFINITOR taken together with exemestane
more than doubles your time
Starting AFINITOR
AFINITOR plus exemestane Exemestane

0 2 4 6 8
7.8
In the clinical trial, AFINITOR combined with exemestane lowered the risk of disease progression by more than half compared to exemestane alone*
55%
MONTHS
3.2
MONTHS
Time to disease progression (months)

*
In the 18-month median follow-up analysis of the BOLERO-2 phase 3 clinical trial.
14
15
Disease Background
Starting AFINITOR Therapy
16
17
Disease Background
Preparing for your treatment journey
starting AFINITOR therapy

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 another medication, exemestane.
Set a schedule and take AFINITOR at the same
Starting AFINITOR
time every day
Decide whether or not you will take AFINITOR Once Daily
10 mg
10 mg Once Daily
with food; for example, if you plan to take AFINITOR with a meal or snack, you must continue taking AFINITOR in this way of water
Swallow AFINITOR tablets whole with a glass
By taking AFINITOR every day as directed by your healthcare team, you have the best chance of slowing the progression of the disease.
18
19
10 mg Once Daily
Disease Background
For best results,
take AFINITOR as directed

What should I avoid while taking AFINITOR?
It is important that you do NOT:
Chew or crush AFINITOR tablets; always
Be sure to discuss the following with your healthcare team before starting therapy with AFINITOR:
Other medications you may be taking while taking AFINITOR
swallow AFINITOR tablets whole with a glass of water

Eat grapefruit or drink grapefruit juice
Starting AFINITOR
Other health conditions Any allergies
while taking AFINITOR

Take St. Johns wort while taking AFINITOR Take AFINITOR without exemestane
20
21
Disease Background
Don't forget
set a schedule, stay on track

What can I do to help remember to take AFINITOR?
218 U S MAY, EBY 29
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 staying on track with your treatment journey:
Schedule taking your medication as part of
<
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.
Starting AFINITOR
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
Speaking with a buddy who is on a similar journey can help you stay motivated with your treatment plan.
computer, cell phone, or watch
22
23
Disease Background
Partner with your team
learn how to identify possible side effects early

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.
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 you feel, 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 treatmentrelated side effects early. You may be concerned that talking with your healthcare team about any side effects you may experience means stopping your treatment 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.
<
Starting AFINITOR
Common side effects that have been reported during AFINITOR treatment include:
Mouth ulcers and sores (also called stomatitis) Rash Feeling weak or tired Diarrhea Nausea Loss of appetite
24
25
Disease Background
common side effects

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 AFINITOR saw symptoms within the first 2 weeks of therapy.
In a clinical trial,* about
2 out of every 3 patients experienced mouth sores

during therapy with AFINITOR and exemestane.
Starting AFINITOR
Talk to your healthcare team to learn more. They may offer some tips 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.
26
*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.
27
Disease Background
common side effects

What is noninfectious pneumonitis?
You may experience lung or breathing problems during therapy with AFINITOR, which may be signs of a condition called noninfectious pneumonitis. In a clinical trial,* half of the patients that experienced pneumonitis during treatment with AFINITOR saw symptoms within the first 4 months of therapy.
1 out of every 6 patients experienced pneumonitis

during therapy with AFINITOR and exemestane.
Starting AFINITOR
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.
28
29
Disease Background
common side effects

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
1 out of every 3 patients
experienced rash during treatment

with AFINITOR and exemestane.
Starting AFINITOR
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 your metabolic and blood levels.
This is an example of the type of rash that patients may experience while being treated with AFINITOR.
30
31
Disease Background
Stay in touch with your healthcare team
report serious side effects immediately

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 if you experience any of the following:
Lung or breathing problems, especially cough,
coughing up blood, chest pain, or shortness of breath

Fever, chills, or any other sign you think may
Starting AFINITOR
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
32
33
Disease Background
To protect your medication
follow storage instructions

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 with AFINITOR 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
Starting AFINITOR
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
34
35
Disease Background
36
37
Disease Background
Continuing forward with AFINITOR
on treatment support
What should I do if I miss a dose of AFINITOR?
It is very important to maintain a consistent schedule when taking AFINITOR and to take your medication as prescribed. If you do miss a dose:
Take your next dose as scheduled at your usual time the
Remember, set a schedule and make taking your AFINITOR tablets part of your daily routine.
Be sure to speak with your healthcare team before starting any new medications. Please refer to pages 18-23 for important reminders for your treatment journey with AFINITOR.
Starting AFINITOR
next day
Do not take two doses to make up for a missed dose Call your healthcare team if you are unsure or have
218 U S MAY, EBY 29
additional questions
<
Using a calendar or a daily reminder may help keep you from missing an AFINITOR dose.
38
39
Disease Background
Possible approaches
side effect management

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).
Your healthcare team may use one of the following approaches to 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
Starting AFINITOR
effect gets better

Add another prescription medicine Recommend a nonprescription medicine
It is important to remember that dose changes and management of side effects are part of all cancer therapies.
Often, managing side effects is needed so you can get the most possible benefit from your treatment.
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.
40
41
Disease Background
Management approaches
stomatitis
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.
Depending on the type of mouth sores and how you are feeling, your healthcare team may recommend the following management approaches:
Use a special mouthwash or mouth gel that does not contain
Starting AFINITOR
alcohol, peroxide, iodine, or thyme

Stop taking AFINITOR for a short period of time and then start
again once the mouth sores improve
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.
42
43
Disease Background
Management approaches
noninfectious pneumonitis
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 noninfectious pneumonitis. 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 healthcare team may recommend:

Treatment with a medication called a
corticosteroid
A break in taking AFINITOR for a
Starting AFINITOR
period of time
44
45
Disease Background
Dose modifications
staying on your treatment journey

Will stopping or changing my AFINITOR dose impact the potential benefit of my treatment?
Managing side effects with dose changes is common in many
Starting AFINITOR
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
Of the patients in a clinical trial* who modified their AFINITOR dose and resumed the 10-mg dose, about 3 out of every 4 were able to do so in 2 weeks.
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
46
47
Disease Background
Reach out for
additional support and resources

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.
These groups and organizations are independent from Novartis. Novartis has no control over, and is not responsible for, any information provided by these entities.
48
49
Disease Background
Continue the conversation
questions for your healthcare team

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 your healthcare team and learn more about metastatic breast cancer, your treatment journey, and therapy with AFINITOR.
Why have I been prescribed AFINITOR?
Starting AFINITOR
How long will I need to take AFINITOR?
How is metastatic breast cancer (MBC) different from earlier stages of the disease?
How will I know if the treatment is working? What are the possible treatment options for MBC? How have my goals for therapy changed from my earlier treatment goals? On Treatment Support
50
51
Disease Background
Important Safety Information Patients should not take AFINITOR if they are allergic to AFINITOR 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 their healthcare 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.
Kidney Failure: Patients taking AFINITOR may develop kidney failure. 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
Starting AFINITOR
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 control while 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 Please see accompanying Summary of Product Characteristics.
53
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Disease Background
Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and 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
Common Side Effects: AFINITOR can cause mouth ulcers and sores. Other common side effects include:
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, Headache Nosebleeds or spontaneous
bleeding or bruising
Pain in arms and legs,
mouth and throat, back or joints

High blood cholesterol
Starting AFINITOR
High blood glucose High blood pressure Difficulty sleeping Hair loss Muscle spasms Feeling dizzy Nail disorders
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.
feet, ankles, face or other parts of the body

Abnormal taste Dry mouth Inflammation of the lining of the
digestive system or lung tissue
Tell your healthcare provider if you have any side effect that bothers you or 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.
54
Please see accompanying Summary of Product Characteristics.
55
Novartis Pharma AG CH-4002 Basel Switzerland Novartis2013
9/13
G-AFI-1066292

G-AFI-1066292 - G 2013 AFI Breast Adv BC AIM Patient Guide

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Moving Forward in Metastatic Breast Cancer

Starting AFINITOR Therapy.................................. 17

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

It can be overwhelming, but know that you arent alone.

Starting AFINITOR On Treatment Support

Starting a new stage of your journey

understanding metastatic breast cancer

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

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

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

hormones estrogen and progesterone to live and to grow

to find out whether the cancer is HR+

breast cancer and is different from earlier forms of the disease

Lymph nodes Lung

the cancer from using estrogen to grow

Primary breast tumor

Know your disease,

know your options

return or spread to a new part of the body

known as disease progression

or stop the growth of certain cancers

a unique treatment choice

AFINITOR plus exemestane

can no longer keep disease under control

Why might AFINITOR be the right choice?

without your tumors growing or spreading, compared to just

AFINITOR taken together with exemestane

more than doubles your time

AFINITOR plus exemestane Exemestane

Time to disease progression (months)

Starting AFINITOR Therapy

Starting AFINITOR On Treatment Support

Preparing for your treatment journey

starting AFINITOR therapy

How do I take AFINITOR?

time every day

Decide whether or not you will take AFINITOR Once Daily

Swallow AFINITOR tablets whole with a glass

For best results,

take AFINITOR as directed

swallow AFINITOR tablets whole with a glass of water

Other health conditions Any allergies

while taking AFINITOR

set a schedule, stay on track

your daily routine, like brushing your teeth

each time you take your medication

computer, cell phone, or watch

Partner with your team

learn how to identify possible side effects early

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

Preparing for your treatment journey

common side effects

In a clinical trial,* about

2 out of every 3 patients experienced mouth sores

alcohol, peroxide, iodine, or thyme

Preparing for your treatment journey

common side effects

In a clinical trial,* about

1 out of every 6 patients experienced pneumonitis

Preparing for your treatment journey

common side effects

In a clinical trial,* about