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Please see Important Safety Information throughout this brochure and the Summary of Important Information on pages 19 to 21.

INDICATION for RYDAPT® (midostaurin) capsules RYDAPT is an oral prescription medicine used in combination with certain chemotherapy medicines to treat adults with newly diagnosed acute myeloid leukemia (AML) who have a defect in a gene called FLT3. Your doctor will perform a test to make sure RYDAPT is right for you. RYDAPT should not be used alone to induce remission in people with AML.It is unknown if RYDAPT is safe and effective in children.

23% Reduction in the risk of death compared with standard-of-care chemotherapy alone— A specific median overall survival (the time point at which half

the patients were still alive) could not be reliably estimated

IMPORTANT SAFETY INFORMATION for RYDAPTAllergic Reactions• Do not take RYDAPT if you are allergic to midostaurin or any of the ingredients in RYDAPT • If you develop signs of an allergic reaction, seek medical help immediately • Signs of an allergic reaction include trouble breathing, flushing, chest pain, throat tightness, and

swelling of the face, lips, tongue, or throat

People depicted throughout this brochure

are not actual patients.

A guide to combination treatment with RYDAPT

THAT TREATING NEWLY DIAGNOSED FLT3-POSITIVE AML HAS CHANGED

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UNDERSTANDING AML

What is AML?AML is a type of blood cancer that primarily affects your white blood cells. In AML, the myeloid stem cells usually become a type of immature white blood cell called myeloblasts (or myeloid blasts). The myeloblasts in AML are abnormal and do not become healthy white blood cells.

Leukemia cells often reproduce quickly, but in most cases the problem is that they don’t die when they should. Acute leukemias, like AML, are fast growing because normal blast cells divide quickly. The leukemia cells don’t divide any more often than normal blast cells do. However, they don’t stop dividing when normal blast cells would.

Being diagnosed with AML can be an overwhelming experience. You may feel like your whole life has been turned upside down. At Novartis, we understand that you’re facing new challenges, but we want you to know that we’re committed to providing you with support.

Understanding AML and how it’s managed is an important first step. The information in this brochure is meant to help you and those close to you learn more about AML and what you might expect throughout your journey. You’ll also learn about your treatment with RYDAPT® (midostaurin) capsules and how it may play an essential role in the overall plan that your health care team has created for you.

IMPORTANT SAFETY INFORMATION (CONTINUED)

Pregnancy, Breastfeeding, Fertility• RYDAPT should not be used during pregnancy since it may harm an unborn baby

• If you become pregnant, think you may be, or are planning to be, tell your doctor right away

• If you are able to become pregnant, your doctor should perform a pregnancy test within 7 days before you start RYDAPT. Effective birth control should be used during treatment and for at least 4 months after the last RYDAPT dose

• Men taking RYDAPT who have female partners who are able to become pregnant should use effective birth control during treatment with RYDAPT and for at least 4 months after the last dose

• Pregnancy registry: There is a pregnancy registry that monitors the health of females and their babies exposed to RYDAPT during pregnancy. Females who have taken RYDAPT during pregnancy, or who have been exposed to RYDAPT during pregnancy through a male partner taking RYDAPT, should contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or at https://psi.novartis.com

• Do not breastfeed during treatment with RYDAPT and for at least 4 months after the final dose

• RYDAPT may impair fertility in males and females. You should discuss this with your doctor before starting treatment


DIAGNOSING AML

How is AML diagnosed?Your doctor uses blood tests and a bone marrow biopsy to determine if you have AML. The table on the next page illustrates the different blood cell counts that can be found in patients with AML. Changes may be seen in the white blood cells, red blood cells, and platelets. The lab may also identify changes in blasts.


Lung Problems• RYDAPT may cause serious lung problems that may lead to death when used alone or in combination with other

chemotherapy medicines

• If you develop a new or worsening cough, shortness of breath, or chest discomfort, contact your doctor immediately. These may be signs of serious lung problems

AML is the most common type of acute leukemia affecting adults. In 2017, an estimated 21,380 people

in the United States will be diagnosed with AML.

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White blood cells

Blasts circulating in the blood

Red blood cells

Platelets

Can be low or high

Variable number

Low

Low

High white blood cell count may represent an excess of immature white blood cells

Blood cell type Count

About 3 out of 10 of patients with AML have the mutated FLT3 gene

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• If side effects including nausea, vomiting, and diarrhea occur, get worse, or do not go away during treatment with RYDAPT, you should contact your doctor immediately. Your doctor may need to decrease your dose, temporarily stop, or completely stop your treatment with RYDAPT

• These are not all of the possible side effects of RYDAPT. For more information, ask your doctor or pharmacist

DIAGNOSING AML (CONTINUED)

Blood-test results that may lead to a diagnosis of AMLYour health care provider may also order additional tests to identify the specific type of AML that you have.

One test that your doctor is likely to use is genetic screening. AML is linked with mutations of certain types of genes. Genetic screening may identify genes that have mutated, including one of the most common AML-related mutations, FLT3. Approximately 30% of patients with AML harbor some form of FLT3 mutation. Identifying such mutations may help your health care provider determine a tailored plan for treating your AML.


Side EffectsMost common side effects reported during RYDAPT treatment for acute myeloid leukemia (AML) included:

• low level of white blood cells with fever (febrile neutropenia)

• nausea

• redness, pain, or ulcers inside the mouth (mucositis)

• vomiting

• headache

• bruising

• muscle or bone pain

• nose bleeds

• device-related infection

• high blood sugar levels (hyperglycemia)

• upper respiratory infection

WHAT IS FLT3-POSITIVE AML, AND HOW DOES IT AFFECT MY TREATMENT OPTIONS?

Approximately 3 out of 10 patients with AML have the mutated FLT3 gene

Your FLT3 status can help you understand why RYDAPT may be a treatment option for you.

Your doctor may have mentioned that you have a specific type of AML known as FLT3-positive AML. FLT3 is a gene that can help determine which AML treatments may be most appropriate for you, allowing your health care provider to design a tailored treatment plan. The DNA in your cells can become altered (or mutated), and when the FLT3 gene is affected, it can play a major role in your cancer’s development.

If your doctor has found that your FLT3 gene is mutated, he or she may have told you that you are positive for FLT3. This is one of the reasons you have been prescribed RYDAPT® (midostaurin) capsules, a medicine to treat this type of AML.

It is unknown if RYDAPT is safe and effective in children.

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5Please see Important Safety Information throughout this brochure and the Summary of Important Information on pages 19 to 21.

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RYDAPT CAN BE AN EFFECTIVE OPTION IN YOUR FLT3-POSITIVE AML TREATMENT PLAN

How is AML treated?Following your initial AML diagnosis, your doctor will order a test to determine your FLT3 status. If you test positive for FLT3, you may receive at least one of the following treatments:

RYDAPT plus chemotherapy

Chemotherapy

Stem cell transplantation

RYDAPT® (midostaurin) capsules is an oral medicine approved by the FDA to treat newly diagnosed FLT3-positive AML. RYDAPT belongs to a group of therapies called protein kinase inhibitors. Protein kinases are enzymes that send signals to help cells grow and divide. Blocking them may help prevent leukemia cells from growing. RYDAPT is thought to block the action of several kinases of leukemia cells, which may help prevent these cells from dividing and growing.

At the start of your newly diagnosed FLT3-positive AML treatment, RYDAPT is always used together with chemotherapy. We will look more closely at possible paths on the following page.


RYDAPT is the first therapy for newly diagnosed FLT3-positive AML approved by the FDA in over 25 years.

YOUR TREATMENT PLAN WILL MOST LIKELY INCLUDE SEVERAL STAGES

INDUCTION (1 to 2 cycles*) CONSOLIDATION (up to 4 cycles)

Chemotherapy: Days 1 to 7Because AML is a disease that can get worse quickly, it’s important that you start treatment for AML right after your diagnosis. This initial stage of treatment, which is given during your stay in the hospital, is called induction therapy and will most likely include chemotherapy. The goals of induction therapy are to:

Kill as many AML cells as possible Get blood counts back to normal Get rid of all signs of the disease for an extended

period of time

During your induction with chemotherapy as part of the diagnostic workup, you may be tested to determine your FLT3 status.

RYDAPT: Days 8 to 21If you have tested positive for FLT3 and your health care provider has prescribed RYDAPT, you will receive it following the first 7 days of induction chemotherapy treatment.

Chemotherapy: Days 1, 3, and 5Because there may be AML cells remaining after the first phase of your treatment (the induction phase), you may need additional therapy. This may include additional rounds of chemotherapy, which can be given while you are in the hospital or as outpatient therapy. Your doctor will discuss what the best treatment plan for you may be.

RYDAPT: Days 8 to 21 Similar to the induction phase, you may receive RYDAPT following your consolidation chemotherapy treatment.†


Please follow your health care provider’s instructions for treatment with RYDAPT


Taking Other Medicines With RYDAPT• Before taking RYDAPT, you should tell your doctor about all the medicines you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements. RYDAPT may affect how these medicines work, or these other medicines may affect how RYDAPT works

• You should also tell your doctor if you are already taking RYDAPT and are prescribed a new medicine that you have not taken previously during RYDAPT treatment

* The number of induction cycles is based on the clinical trial. Your health care provider may choose to adjust this number depending on your individual treatment plan.†In a clinical study, RYDAPT was given on Day 8 of treatment following chemotherapy.

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357patients received

placebo plus chemotherapy

717patients were studied to

determine whether adding RYDAPT® (midostaurin) capsules

to chemotherapy would help them live longer

360patients received

RYDAPT plus chemotherapy

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More patients taking RYDAPT plus chemotherapy (59%) received stem cell transplant (SCT) than patients taking chemotherapy alone (55%).

At the time of SCT, study medication was stopped in these patients.

In addition, patients who received RYDAPT with chemotherapy in the trial went longer

without certain complications (failure to achieve complete remission within 60 days of starting treatment, progression of leukemia,

or death) than patients who received chemotherapy alone.

• Median 8.2 months vs median 3 months


Pregnancy, Breastfeeding, Fertility• RYDAPT should not be used during pregnancy since it may harm an unborn baby

• If you become pregnant, think you may be, or are planning to be, tell your doctor right away

• If you are able to become pregnant, your doctor should perform a pregnancy test within 7 days before you start RYDAPT. Effective birth control should be used during treatment and for at least 4 months after the last RYDAPT dose

• Men taking RYDAPT who have female partners who are able to become pregnant should use effective birth control during treatment with RYDAPT and for at least 4 months after the last dose

• Pregnancy registry: There is a pregnancy registry that monitors the health of females and their babies exposed to RYDAPT during pregnancy. Females who have taken RYDAPT during pregnancy, or who have been exposed to RYDAPT during pregnancy through a male partner taking RYDAPT, should contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or at https://psi.novartis.com

• Do not breastfeed during treatment with RYDAPT and for at least 4 months after the final dose

• RYDAPT may impair fertility in males and females. You should discuss this with your doctor before starting treatment

A specific median overall survival (the time point at which half the patients were still alive) could not be reliably estimated.

Reduction in the risk of death compared with standard-of-care chemotherapy alone

23%Patients who received treatment with RYDAPT plus chemotherapy lived longer than patients receiving chemotherapy alone

RYDAPT HAS BEEN PROVEN TO HELP PATIENTS WITH NEWLY DIAGNOSED FLT3-POSITIVE AML LIVE LONGER



Allergic Reactions• Do not take RYDAPT if you are allergic to midostaurin or any of the ingredients in RYDAPT

• If you develop signs of an allergic reaction, seek medical help immediately

• Signs of an allergic reaction include trouble breathing, flushing, chest pain, throat tightness, and swelling of the face, lips, tongue, or throat

In a clinical trial of adult patients with newly diagnosed FLT3-positive AML:

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INDUCTION (1 to 2 cycles) CONSOLIDATION (up to 4 cycles)

ChemotherapyDays 1 to 7

ChemotherapyDays 1, 3, and 5

RYDAPT 2x/dayDays 8 to 21*

After testing positive for FLT3

RYDAPT 2x/dayDays 8 to 21*

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How long will I need to stay on RYDAPT?

What should I know about taking RYDAPT while sexually active?

What if I’m pregnant or lactating, or plan on becoming pregnant?

How will taking RYDAPT at home be different than taking it in the hospital?

QUESTIONS TO ASK YOUR DOCTOR

Communicate regularly with your health care provider so informed decisions can be made regarding your treatment. Following are a few questions that you may want to ask your doctor about treatment. Be sure to bring up any additional questions that may help you better understand how to get the most out of your treatment, as all of your questions are important.

What symptoms or side effects should I tell my doctor about right away?

How will I know if my treatment with RYDAPT® (midostaurin) capsules is working?

What if I forget to take RYDAPT?

Do I need to change my diet during treatment with RYDAPT?

Is monitoring required while I’m taking RYDAPT?

What if I stop taking RYDAPT?

What if I take too much RYDAPT?


TAKING RYDAPT TO TREAT NEWLY DIAGNOSED FLT3-POSITIVE AML

A twice-daily oral medicineDuring your stay in the hospital, clinic staff will give you RYDAPT at the recommended dose of 50 mg (two 25-mg capsules) twice a day—taken 12 hours apart—in addition to your regular chemotherapy. RYDAPT comes in a soft, orange capsule and is taken by mouth with food. RYDAPT is only available in 25-mg capsules.

Your doctor will likely begin to give you RYDAPT the day after your first 7 days of induction chemotherapy.

Your doctor may tell you to decrease your dose, temporarily stop, or completely stop taking RYDAPT if you develop certain side effects during treatment with RYDAPT.

* In a clinical study, RYDAPT was given on Day 8 of treatment following chemotherapy.


Lung Problems• RYDAPT may cause serious lung problems that may lead to death when used alone or in combination with other

chemotherapy medicines

• If you develop a new or worsening cough, shortness of breath, or chest discomfort, contact your doctor immediately. These may be signs of serious lung problems

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Taking RYDAPT at the same time each day will help you remember when to take your medicine.

Your doctor may prescribe additional medicines to help with nausea, if necessary.

TWICE A DAYTwo 25-mg capsules

50 mg, 2x/day


Capsules not actual size

How to take RYDAPT

Always take RYDAPT® (midostaurin) capsules exactly as your doctor or pharmacist has told you to. Your doctor or pharmacist will tell you exactly how many capsules of RYDAPT you need to take. Do not change the dose without talking to your doctor.

TIPS FOR TAKING RYDAPT







• nausea


• vomiting

• headache

• bruising


• nose bleeds




The usual dosage is 50 mg (2 capsules), twice daily (4 capsules total per day)

Take RYDAPT every 12 hours and at approximately the same time each day (for example, once in the morning and once in the evening)

Swallow RYDAPT capsules whole with a glass of water. Do not open, crush, or chew the capsules. Take RYDAPT with food

RYDAPT is administered according to a dosage regimen together with chemotherapy treatments. It is very important to follow your doctor’s recommendation

If you miss a dose of RYDAPT, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose

If you vomit after taking a dose of RYDAPT, do not take an extra dose. Take your next dose at your scheduled time

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Keep a notebook with treatment-related information.

Be sure to ask questions and take notes during medical appointments so that you can review them later. Keep track of the contact information for your loved one’s health care team, as well as important information about medicines, dosages, symptoms, and side effects of treatments.

Learn about insurance and/or financial resources that may be available.

Navigating insurance issues can be challenging, but it’s possible to get help. A doctor and his or her office staff can help you sort out some of the details, and if your loved one is prescribed RYDAPT® (midostaurin) capsules, Novartis has a patient support program for eligible patients. Learn more about RYDAPT NOW, brought to you by Novartis Patient Assistance Now Oncology, on the following pages and visit www.RYDAPT-NOW.com to learn how to enroll.


When someone learns that they have FLT3-positive AML, there is suddenly a lot of information that needs to be processed, as well as practical considerations about going to the hospital and taking care of things at home. It may be difficult for a patient to absorb all of these details, especially at a time when they’re not feeling well and are experiencing a wide range of emotions.

Your role as a caregiver is an important one—you are not only a source of support and comfort, but also an advocate for your loved one with newly diagnosed FLT3-positive AML. You become their eyes and ears, and are there at doctor’s visits to listen and record information about what can be expected during the treatment journey. You are also the person who helps them stay on track with their treatments and medicines and helps them to meet their basic needs.

As a caregiver, we understand that you’re also dealing with your own emotions, as well as the day-to-day considerations that accompany caring for someone with newly diagnosed FLT3-positive AML. Following are some tips that may be useful while you’re helping your loved one through this time.

CAREGIVERS PLAY AN ESSENTIAL ROLE IN THE LIVES OF PATIENTS WITH AML TIPS FOR CAREGIVERS

Try to stay positive.

Your outlook can make a big difference in the life of your loved one with newly diagnosed FLT3-positive AML. Of course, remaining positive isn’t always easy, so seek out advice and support from family members, friends, professional counselors, and doctors. Patient advocacy groups can put you in touch with others who are going through a similar situation.

Make time for yourself.

It can be easy to neglect yourself while you’re caring for someone with newly diagnosed FLT3-positive AML. Be sure to continue to eat right and exercise, and take some time to relax.


Taking Other Medicines With RYDAPT• Before taking RYDAPT, you should tell your doctor about all the medicines you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements. RYDAPT may affect how these medicines work, or these other medicines may affect how RYDAPT works

• You should also tell your doctor if you are already taking RYDAPT and are prescribed a new medicine that you have not taken previously during RYDAPT treatment

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10CO-PAY

$

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Care Coordinators at RYDAPT NOW can help you gain access to your medicine and provide the following support:

For appropriate patients with AML

Assisting you with access to RYDAPT® (midostaurin) capsules as you transition between inpatient and outpatient settings

Helping you find a pharmacy based on your insurance plan, and get your medicine according to your plan’s guidelines

Providing information about financial assistance that may be available

Offering support with insurance verification to help you understand how to get your medicine and what your financial responsibilities are

Providing information about prior authorization requirements

Initiating a benefits investigation in the inpatient setting in preparation for transitioning to the outpatient setting

RYDAPT NOW—YOUR PARTNER FOR ACCESS AND FINANCIAL SUPPORT

Novartis cannot guarantee that patients who enroll in RYDAPT NOW will be successful in obtaining insurance coverage for treatment or will receive financial assistance.

Call 1-800-282-7630 or visit www.RYDAPT-NOW.com for information on how to enroll in RYDAPT NOW and to learn more about the ways we can help.

To find out if you are eligible for the Novartis Oncology Universal Co-pay Program, call 1-877-577-7756 or visit www.CoPay.NovartisOncology.com.


If your doctor prescribes RYDAPT for newly diagnosed FLT3+ AML based on the approved label and there is a delay in your insurance coverage as you transition out of the hospital, you may be eligible to receive a free 14-day supply of RYDAPT shipped directly to your home to avoid disruption in your treatment.

No purchase of RYDAPT is required. Novartis cannot guarantee that every patient who enrolls in RYDAPT NOW will be successful in obtaining insurance coverage for treatment.

Novartis Oncology Universal Co-Pay Program

* Limitations apply. This offer is only available to patients with private insurance. The program is not available for patients that are enrolled in Medicare, Medicaid, or any other federal or state health care program. Novartis reserves the right to rescind, revoke, or amend this program without notice. For full Terms and Conditions, visit www.CoPay.NovartisOncology.com or call 1-877-577-7756.

You may be eligible for immediate co-pay savings on your next prescription of RYDAPT.

Eligible patients with private insurance may pay $10 per month*

Novartis will pay the remaining co-pay, up to $15,000 per calendar year

Terms and Conditions: The Novartis Oncology Universal Co-pay Program includes the co-pay card, payment card, or rebate with a combined annual limit of $15,000. Patient is responsible for any costs once the limit is reached in a calendar year. This offer is only available to patients with private insurance. The program is not available for patients who: (i) are enrolled in Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program; (ii) are not using insurance coverage at all; (iii) are enrolled in an insurance plan that reimburses for the entire cost of the drug; or (iv) where product is not covered by patient’s insurance. The value of this program is exclusively for the benefit of enrolled patients and is intended to be credited toward patient out-of-pocket obligations, including applicable co-payments, coinsurance, and deductibles. Proof of purchase may be required. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of his/her health plan related to the use of the program. Program is not valid where prohibited by law. Valid only in the United States and Puerto Rico. Offer is not valid for California or Massachusetts residents for certain medications. This program is not health insurance. This program may not be combined with any third-party rebate, coupon, or offer. Novartis reserves the right to rescind, revoke, or amend the program and discontinue support at any time without notice.

Patient Instructions: After enrollment in the program, present this card and your insurance card along with a valid prescription at any participating pharmacy or through mail order. Patients are responsible for up to the first $25 (specific offer varies by brand) and Novartis pays up to $15,000 per calendar year. If patient reaches the maximum annual cap per calendar year of $15,000, patient will be responsible for the difference.

When you use this card, you are certifying that you understand and agree to comply with the program Terms and Conditions above.

Direct patient questions to: 1-877-577-7756.

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SUMMARY OF IMPORTANT INFORMATION

What is RYDAPT?

RYDAPT® (midostaurin) capsules is a prescription medicine used to treat adults:

newly diagnosed with a certain type of acute myeloid leukemia (AML), in combination with certain chemotherapy medicines— Your health care provider will perform a test to make

sure RYDAPT is right for you

It is not known if RYDAPT is safe and effective in children.

Before you take RYDAPT, tell your health care provider about all of your medical conditions, including if you:

Do not take RYDAPT if you are allergic to midostaurin or any of the ingredients in RYDAPT. See page 21 for a complete list of ingredients in RYDAPT.

Signs and symptoms of an allergic reaction to RYDAPT have included trouble breathing, flushing, chest pain, throat tightness, and swelling of your lips, mouth, or throat. Get medical help right away if you have any of these signs or symptoms

have any lung or breathing problems

are pregnant or plan to become pregnant. RYDAPT may cause harm to your unborn baby. Tell your health care provider right away if you become pregnant during treatment with RYDAPT or think you may be pregnant

Pregnancy Registry: There is a pregnancy registry that monitors the health of females and their babies exposed to RYDAPT during pregnancy. Females who have taken RYDAPT during pregnancy, or who have been exposed to RYDAPT during pregnancy through a male partner taking RYDAPT, should contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or at https://psi.novartis.com

— If you are able to become pregnant, your health care provider may perform a pregnancy test within 7 days before you start RYDAPT

— Females who are able to become pregnant should use effective birth control (contraception) during treatment with RYDAPT and for at least 4 months after the last dose of RYDAPT

— Males who have female partners that are able to become pregnant should use effective birth control during treatment with RYDAPT and for at least 4 months after the last dose of RYDAPT

are breastfeeding or plan to breastfeed. It is not known if RYDAPT passes into your breast milk. You should not breastfeed during treatment with RYDAPT and for at least 4 months after the last dose of RYDAPT

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

HOW TO ENROLL IN RYDAPT NOW

RYDAPT NOW Care Coordinators are able to provide information in more than 160 languages.

Complete the Service Request Form with your health care provider and fax it to 1-888-891-4924

Call 1-800-282-7630 from 9 to 8 ET, Monday

through Friday, to begin the enrollment process

Access RYDAPT NOW online at www.RYDAPT-NOW.com and download the Service

Request Form

OR

Please see Important Safety Information throughout this brochure.

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What are the possible side effects of RYDAPT?

RYDAPT may cause serious side effects, including: Lung problems. RYDAPT may cause lung problems that may lead to death when used alone or in combination with other chemotherapy medicines. Get medical help right away if you have any new or worsening lung symptoms, including cough, chest discomfort, or shortness of breath

Call or inform your health care provider if nausea, vomiting, or diarrhea occurs, gets worse, or does not go away.

RYDAPT may cause fertility problems in females and males, which may affect your ability to have children. Talk to your health care provider if you have concerns about fertility.

Your health care provider may tell you to decrease your dose, temporarily stop, or completely stop taking RYDAPT if you develop certain side effects during treatment with RYDAPT.

Your health care provider will do blood tests to check you for side effects during treatment with RYDAPT.

These are not all of the possible side effects of RYDAPT. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The most common side effects of RYDAPT in people with AML include: low white blood cell counts with fever (febrile neutropenia)

nausea redness, pain, or ulcers on the inside of your mouth (mucositis)

vomiting headache bruising muscle or bone pain

nose bleeds device-related infection high blood sugar levels (hyperglycemia) upper respiratory tract infection

SUMMARY OF IMPORTANT INFORMATION (CONTINUED)

How should I take RYDAPT? Take RYDAPT® (midostaurin) capsules exactly as your health care provider tells you

Your health care provider will tell you how many capsules of RYDAPT you need to take. Do not change your dose unless your health care provider tells you to

Your health care provider will prescribe medicines to help prevent the nausea and vomiting during treatment with RYDAPT

Take RYDAPT 2 times a day (about every 12 hours apart)

Take RYDAPT with food

Do not open or crush RYDAPT capsules

If you miss a dose of RYDAPT, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose

If you vomit after taking a dose of RYDAPT, do not take an extra dose. Take your next dose at your scheduled time

How should I store RYDAPT? Store RYDAPT at room temperature between 68°F to 77°F (20°C to 25°C) Keep RYDAPT in the original package to protect from moisture

Keep RYDAPT and all medicines out of the reach of children.

General information about the safe and effective use of RYDAPTMedicines are sometimes prescribed for conditions not listed in the Patient Information. Do not take RYDAPT for a condition for which it was not prescribed. Do not give RYDAPT to other people, even if they have the same condition or symptoms you have. It may harm them. You can ask your pharmacist or health care provider for information about RYDAPT that is written for health care professionals.

What are the ingredients in RYDAPT?Active ingredient: midostaurin

Inactive ingredients: polyoxyl 40 hydrogenated castor oil, gelatin, polyethylene glycol 400, glycerin 85%, dehydrated alcohol, corn oil mono-di-triglycerides, titanium dioxide, vitamin E, ferric oxide yellow, ferric oxide red, carmine, hypromellose 2910, propylene glycol, and purified water

Please see Important Safety Information throughout this brochure.

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Understanding AML AML is the most common type of acute leukemia

affecting adults. In 2017, an estimated 21,380 people in the United States will be diagnosed with AML

It’s important that you know your FLT3 status, as being FLT3 positive affects what treatment options may be available for you

INDICATION for RYDAPT® (midostaurin) capsulesRYDAPT is an oral prescription medicine used in combination with certain chemotherapy medicines to treat adults with newly diagnosed acute myeloid leukemia (AML) who have a defect in a gene called FLT3. Your doctor will perform a test to make sure RYDAPT is right for you. RYDAPT should not be used alone to induce remission in people with AML.


SUMMARY






• RYDAPT may cause harm to your unborn baby. Tell your health care provider right away if you become pregnant during treatment with RYDAPT or think you may be pregnant. See page 19 for additional information

• RYDAPT may cause lung problems that may lead to death when used alone or in combination with other chemotherapy medicines. Get medical help right away if you have any new or worsening lung symptoms, including cough, chest discomfort, or shortness of breath. See page 20 for additional information


• nausea


• vomiting

• headache

• bruising


• nose bleeds




RYDAPT has been proven to help people with newly diagnosed FLT3-positive AML live longer 23% reduction in the risk of death compared with standard-of-care chemotherapy alone

— A specific median overall survival (the time point at which half the patients were still alive) could not be reliably estimated

RYDAPT is a capsule used to treat newly diagnosed FLT3-positive AML The usual dosage is 50 mg (2 capsules), twice daily (4 capsules total per day)

Take RYDAPT every 12 hours and at approximately the same time each day (for example, once in the morning and once in the evening)

PROOFLIVINGMy

THAT TREATING NEWLY DIAGNOSED FLT3-POSITIVE AML HAS CHANGED


INDICATION for RYDAPT® (midostaurin) capsules RYDAPT is an oral prescription medicine used in combination with certain chemotherapy medicines to treat adults with newly diagnosed acute myeloid leukemia (AML) who have a defect in a gene called FLT3. Your doctor will perform a test to make sure RYDAPT is right for you. RYDAPT should not be used alone to induce remission in people with AML.


IMPORTANT SAFETY INFORMATION for RYDAPTAllergic Reactions• Do not take RYDAPT if you are allergic to midostaurin or any of the ingredients in RYDAPT • If you develop signs of an allergic reaction, seek medical help immediately • Signs of an allergic reaction include trouble breathing, flushing, chest pain, throat tightness,

and swelling of the face, lips, tongue, or throat

23% Reduction in the risk of death compared with standard- of-care chemotherapy alone— A specific median overall survival

(the time point at which half the patients were still alive) could not be reliably estimated

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080 © 2019 Novartis 1/19 MID-1203298

Complete the Service Request Form with your health care provider and fax it to 1-888-891-4924

Call 1-800-282-7630 from 9 to 8 ET, Monday

through Friday, to begin the enrollment process

Access RYDAPT NOW online at www.RYDAPT-NOW.com and download the Service

Request Form

For information on retail and/or specialty pharmacies that can fill your prescription for RYDAPT, call RYDAPT NOW at 1-800-282-7630.

OR

How to enroll in RYDAPT NOW

my living proof - rydapt...proof living my please see important safety information throughout this...

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