Download SEARCHING FOR A GI NET TREATMENT? LOOK TO AFINITOR

GI NET
SEARCHING FOR A
GI NET TREATMENT?
LOOK TO AFINITOR
AFINITOR is a prescription medicine used to treat adults with a
type of cancer known as neuroendocrine tumor (NET) of the stomach
and intestine (gastrointestinal) or lung that has progressed and
cannot be treated with surgery.
AFINITOR is not for use in people with carcinoid tumors that actively
produce hormones.
Please see Summary of Important Information on pages 12-16,
and click here for full Prescribing Information for AFINITOR,
including Patient Information.
1
2
CONTENTS
What Is Progressive GI NET?
3
What Is AFINITOR?
4
SHINE A LIGHT
ON YOUR PROGRESSIVE
GI NET TREATMENT
How Does AFINITOR Work?
4
Your path has led you to AFINITOR® (everolimus) Tablets.
Why Look to AFINITOR?
5
As you begin your treatment, understanding your condition and learning more
How Should I Take AFINITOR?
6
about AFINITOR, including its benefits and risks, how to take it, how it works
What Are the Side Effects of AFINITOR?
7
Patient Support
10
Summary of Important Information
12
in the body, and where to go for support, can help you take control of your
care and better communicate with your health care team.
Continue to work with your doctor, learn what to expect from AFINITOR,
and remember that you are not alone in the fight.
For more information on treatment and support, visit www.AFINITOR.com
Sincerely,
The AFINITOR Team
IMPORTANT SAFETY INFORMATION
AFINITOR can cause serious side effects such as lung or breathing problems,
infections, or kidney failure. Some of these side effects can be severe and can
even lead to death.
Please see Summary of Important Information on
pages 12-16, and click here for full Prescribing Information
for AFINITOR, including Patient Information.
3
4
WHAT IS AFINITOR?
Gastrointestinal (GI) NET is a rare form of cancer that starts in different parts of the
AFINITOR® (everolimus) Tablets is a prescription medicine for adults that is used
GI tract. The GI tract is a part of the body’s digestive system, and is made up of the
to treat NET of the stomach and intestine (gastrointestinal) or lung that has
stomach, small intestine, colon, and rectum.
progressed and cannot be treated with surgery.
AFINITOR is not for use in people with carcinoid tumors that actively
Understanding progression
Progression means that the tumor has become worse or spread from where it
produce hormones.
have no noticeable symptoms. By the time most patients are diagnosed, their GI
HOW DOES AFINITOR WORK?
NET has progressed. At this point, if removing the tumor through surgery is no
AFINITOR works by blocking the mammalian target of rapamycin (mTOR)
longer possible, your doctor will recommend another treatment.
protein*. In doing so, AFINITOR helps slow blood vessels from feeding
started in the GI tract. GI NET tumors tend to be slow growing and patients may
GI NET is often detected during procedures for
other GI-related issues
2
3
4
The GI tract
includes:
tei
By blocking the mTOR protein,
AFINITOR may help slow
the growth of some
types of cancer cells.
*Although AFINITOR
has been studied in
patients with
progressive GI NET, how
AFINITOR works has
been demonstrated only
in laboratory studies.
1
pro
that your tumor does not release hormones that cause specific symptoms.
healthy, nontumor cells.
mT
OR
You may hear your doctor describe your GI NET as “nonfunctional”. This means
n
oxygen and nutrients to the tumor. AFINITOR may also affect
Nonfunctional NET
AF
IN
IT
OR
Cancer Cell
IMPORTANT SAFETY INFORMATION
In some patients, lung or breathing problems may be severe and can even lead
1
Stomach
to death. Patients should tell their health care provider right away if they have any
2
Small Intestine
of these symptoms: new or worsening cough, shortness of breath, chest pain,
3
Colon
4
Rectum
difficulty breathing, or wheezing.
Please see Summary of Important Information on
pages 12-16, and click here for full Prescribing Information
for AFINITOR, including Patient Information.
GI NET & AFINITOR
WHAT IS PROGRESSIVE GI NET?
5
6
WHY LOOK TO AFINITOR?
HOW SHOULD
I TAKE AFINITOR?
In a clinical trial, patients with progressive GI or
lung NET lived for 7 months longer without the
disease getting worse.
Once a day at the same time each day
AFINITOR® (everolimus) Tablets is a prescription medicine that is a once-daily
oral tablet. Your doctor will prescribe the dose of AFINITOR that is right for
MEDIAN
PROGRESSIONFREE SURVIVAL
PERIOD
you. Take AFINITOR exactly as prescribed by your doctor. Your doctor may
7-month improvement in
progression-free survival
sugar pill
3.9 months
When taking AFINITOR tablets:
AFINITOR
11 months
DO
00
MONTHS
12
12
Use scissors
to open the
blister packs.
205 patients received AFINITOR® (everolimus) Tablets*
97 patients received sugar pills*
During the clinical trial, 2% of patients who took AFINITOR had their tumor size
reduced, compared with 1% of patients who took a sugar pill.
Data has not shown a statistically significant increase in overall survival
compared to a sugar pill.
Take it
whole - not
crushed, chewed,
or broken.
Take at the same
time each day
with a glass
of water.
Always take
with food or
always take
without food.
If you take too much AFINITOR: Contact your health care
provider or go to the nearest hospital emergency room right
away. Take the pack of AFINITOR with you.
If you miss a dose of AFINITOR: You may still take it up to
Number includes patients with either lung or GI NET.
*
6 hours after the time you normally take it. If it is more than
6 hours after you normally take your AFINITOR, skip the dose
IMPORTANT SAFETY INFORMATION
AFINITOR may make patients more likely to develop an infection, such as pneumonia,
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 health care provider right
away if they have a temperature of 100.5˚F or above, have 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 stools or
dark urine, yellowing of the skin, or pain in the upper right side of the stomach.
for that day. The next day, take AFINITOR at your usual time. Do
not take 2 doses to make up for a missed dose. If you are not
sure about what to do, call your health care provider.
DO
NOT
You should not drink grapefruit juice or eat grapefruit
during your treatment. It may make the amount of
AFINITOR in your blood increase to a harmful level.
Please see Summary of Important Information on
pages 12-16, and click here for full Prescribing Information
for AFINITOR, including Patient Information.
STARTING AFINITOR
(how long a patient
lives without the
disease getting
worse)
change your dose or tell you to temporarily interrupt dosing if needed.
7
8
WHAT ARE
THE SIDE EFFECTS OF AFINITOR?
in people who take an Angiotensin-Converting Enzyme (ACE) inhibitor, a type of
blood pressure medication, during treatment with AFINITOR® (everolimus) Tablets.
It is important to tell your doctor as soon as possible about any side effects
Talk with your health care provider before taking AFINITOR if you are not sure
you have while taking AFINITOR (everolimus) Tablets. Don’t delay reporting
if you take an ACE inhibitor medicine. Get medical help right away if you have
®
symptoms, as they may worsen. Your doctor may have to reduce the dose of
AFINITOR or stop AFINITOR until symptoms get better.
AFINITOR can cause serious side effects that include:
1 You may develop lung or breathing problems. In some people lung or
breathing problems may be severe, and can even lead to death. Tell your
2
3 Possible increased risk for a type of allergic reaction called angioedema
trouble breathing or develop swelling of your tongue, mouth, or throat during
treatment with AFINITOR.
4 You may develop kidney failure. In some people this may be severe and can
even lead to death. Your health care provider should do tests to check your kidney
function before and during your treatment with AFINITOR.
health care provider right away if you have any of these symptoms:
If you have any of the serious side effects listed above, you may need to stop
New or worsening cough
Chest pain
taking AFINITOR for a while or use a lower dose. Follow your health care
Shortness of breath
Difficulty breathing or
wheezing
provider’s instructions.
You may be more likely to develop an infection, such as pneumonia, or a
bacterial, fungal or viral infection. Viral infections may include active hepatitis B
SIDE EFFECTS
in people who have had hepatitis B in the past (reactivation). In some people
these infections may be severe, and can even lead to death. You may need to
be treated as soon as possible.
Tell your health care provider right away if you have a temperature of 100.5˚F
or above, chills, or do not feel well.
Symptoms of hepatitis B or infection may include the following:
• Fever
• Nausea
• Chills
• Pale stools or dark urine
• Skin rash
• Yellowing of the skin
• Joint pain and inflammation
• Pain in the upper right side of
the stomach
• Tiredness
• Loss of appetite
Please see Summary of Important Information on
pages 12-16, and click here for full Prescribing Information
for AFINITOR, including Patient Information.
9
10
Common side effects of AFINITOR include:
Common side effects include mouth ulcers. AFINITOR® (everolimus) Tablets
can cause mouth ulcers and sores. Tell your health care provider if you have
pain, discomfort, or open sores in your mouth. Your health care provider may
tell you to use a special mouthwash or gel that does not contain alcohol,
hydrogen peroxide, iodine, or thyme.
Other common side effects include:
• Infections
• Fever
• Diarrhea
• Weight loss or loss
of appetite
• Swelling of the arms, hands, feet, ankles,
face or other parts of the body
PATIENT SUPPORT
$25 CO-PAY CARD
YOU MAY BE ELIGIBLE FOR IMMEDIATE
CO-PAY SAVINGS ON YOUR NEXT PRESCRIPTION:
• Commercially insured patients pay no more
than $25 per month
• Annual maximum of $15,000 per calendar year
To find out if you are eligible to save on your
next prescription, call 1-877-577-7756
or visit us on www.copay.novartisoncology.com
• Vomiting
• Feeling weak or tired
• Abnormal taste
• Rash, dry skin, and itching
• Nose bleeds
• Cough, shortness of breath
• High blood glucose
• Nausea
Limitations apply. See program terms and conditions below. This offer is not valid under
Medicare, Medicaid, or any federal or state program. Novartis reserves the right to rescind, revoke,
or amend this program without notice.
For full Terms and Conditions go to www.copay.novartisoncology.com.
Other side effects that may occur with AFINITOR:
• Absence of menstrual periods (menstruation). You may miss 1 or more
menstrual periods. Tell your health care provider if this happens.
• AFINITOR may affect fertility in females and males and may affect your ability
to become pregnant if you are female or your ability to father a child if you
are male. Talk to your health care provider if this is a concern for you.
Tell your health care provider if you have any side effects that bother you or
do not go away.
You are encouraged to report negative side effects of prescription drugs to
the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
PATIENT SUPPORT
Please see Summary of Important Information on
12 and click here for full Prescribing Information
pages 12-16,
for AFINITOR, including Patient Information.
11
12
PATIENT SUPPORT (CONT)
Patient Assistance
Now Oncology
Novartis Oncology is committed to helping patients who are living with cancer receive
the medicines they need. Patient Assistance Now Oncology (PANO) offers quick and
easy access to information about our wide range of resources.
You can get information about our PANO support programs in 2 ways:
• Call 1-800-282-7630 to speak with a member of our knowledgeable staff dedicated to making access to therapy as simple and convenient as possible; or
• Visit our website at www.OncologyAccessNow.com/patient
Here are some of the ways we can help:
• Offer support with insurance verification to help you understand your financial responsibilities and where to get your medicine
• Assist with changes in your insurance plan when your coverage changes
• Help you find a pharmacy covered by your plan, and get medication based on your plan guidelines
• Provide Medicare education
• Provide information about financial assistance that may be available SUMMARY OF
IMPORTANT INFORMATION
What is AFINITOR used for?
AFINITOR® (everolimus) Tablets is a prescription medicine used to treat adults with a
type of cancer known as neuroendocrine tumor (NET) of the stomach and intestine
(gastrointestinal) or lung that has progressed and cannot be treated with surgery.
AFINITOR is not for use in people with carcinoid tumors that actively
produce hormones.
What is the most important information I should know about AFINITOR?
AFINITOR can cause serious side effects that 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 health care provider’s 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 health care 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, 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 health care provider right away if they have a temperature of 100.5˚F or above, have 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 stools or dark urine, yellowing of the skin, or pain in the upper right side of the stomach.
13
14
SUMMARY OF
IMPORTANT INFORMATION (CONT) Angioedema: Patients who take an angiotensin-converting enzyme (ACE) inhibitor medicine during treatment with AFINITOR® (everolimus) Tablets are at a possible increased risk for a type of allergic reaction called angioedema. Talk with your
health care provider before taking AFINITOR if you are not sure if you take an ACE inhibitor medicine. Get medical help right away if you have trouble breathing or develop swelling of your tongue, mouth, or throat during treatment with AFINITOR.
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.
Delayed Wound Healing: AFINITOR can cause incisions to heal slowly or not heal
well. Call your health care provider right away if your incision is red, warm, or painful;
if you have blood, fluid, or pus in your incision; if your incision opens up; or if your
incision swells.
Who should not take AFINITOR?
Do not take AFINITOR if you are allergic to everolimus or to any of the ingredients in
AFINITOR. Talk to your doctor or pharmacist before taking this medicine if you are allergic
to sirolimus, also known as Rapamune® or temsirolimus, also known as Torisel®.
What should I tell my health care provider before taking AFINITOR?
Before taking AFINITOR, tell your health care provider about all your medical conditions,
including if you:
•
Have or have had kidney problems
•
Have high blood cholesterol levels
•
Have or have had liver problems
•
Have any infections
•
Have diabetes or high blood sugar
•
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 health care provider
•
Have other medical conditions
•
Are pregnant or could become pregnant. AFINITOR can cause harm to your unborn baby. If you are able to become pregnant, you should use effective birth control while using AFINITOR and for 8 weeks after your last dose. Talk to your health care provider about birth control options while taking AFINITOR
•
Are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 2 weeks after your last dose
What other medications might interact with AFINITOR?
Tell your health care provider about all of the medicines you take, including prescription
and nonprescription medicines, vitamins, and herbal supplements. AFINITOR may
affect the way other medicines work, and other medicines can affect how AFINITOR
works. Using AFINITOR with certain other medicines can cause serious side effects.
Keep a list of medicines you take and show it to your health care provider when you
get a new medicine. Especially tell your health care provider if you take St John’s wort
(Hypericum perforatum), medicines that weaken your immune system (your body’s
ability to fight infections and other problems), or medicines for:
•
Fungal infections
• Tuberculosis
•
HIV-AIDS
•
Bacterial infections
•
•
Heart conditions or high blood pressure
Seizures
If you are taking any medicines for the conditions listed above, your health care provider
might need to prescribe a different medicine or your dose of AFINITOR may need to be
changed. Tell your health care provider before you start taking any new medicine.
What laboratory tests do I need when taking AFINITOR?
Your doctor should do laboratory and blood tests to check your kidney and liver function,
blood sugar, cholesterol, and blood count before you start AFINITOR and periodically
during your treatment with AFINITOR.
15
16
SUMMARY OF
IMPORTANT INFORMATION (CONT)
What are other side effects of AFINITOR?
Common Side Effects: Common side effects include mouth ulcers.
AFINITOR® (everolimus) Tablets can cause mouth ulcers and sores. Tell your health care
provider if you have pain, discomfort, or open sores in your mouth. Your health care
provider may tell you to use a special mouthwash or gel that does not contain alcohol,
hydrogen peroxide, iodine, or thyme.
Other common side effects include:
•
Infections
•
Diarrhea
•
Swelling of arms, hands, feet, ankles,
or other parts of the body
•
Feeling weak or tired
•
Rash, dry skin, and itching
•
Cough, shortness of breath
•
Nausea
•
Fever
• Weight loss or loss of appetite
• Vomiting
•
Abnormal taste
•
Nose bleeds
•
High blood glucose
Other side effects that may occur with AFINITOR:
• Absence of menstrual periods (menstruation). You may miss 1 or more menstrual periods. Tell your health care provider if this happens
• AFINITOR may affect fertility in females and males and may affect your ability to become pregnant if you are female or your ability to father a child if you are male.
Talk to your health care provider if this is a concern for you.
Tell your health care provider if you have any side effect that bothers you or does not
go away.
General information about the safe and effective use of AFINITOR
Do not use AFINITOR for a condition for which it was not prescribed. Do not give
AFINITOR to other people, even if they have the same symptoms that you have. It may
harm them. You can ask your health care provider or pharmacist for information about
AFINITOR that is written for health care professionals.
These are not all of the possible side effects of AFINITOR. For more information, talk
with your health care provider or pharmacist or call 1-888-669-6682. The FDA-approved
product labeling or prescribing information can be found at www.us.afinitor.com.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
17
NOTES
18
For more information,
visit www.AFINITOR.com
Please see Summary of Important Information on
pages 12-16, and click here for full Prescribing Information
for AFINITOR, including Patient Information.
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936-1080
© 2016 Novartis
8/16
AGN-1144778