keeping track of your ph+ cml treatment - novartis · pdf filenewly diagnosed philadelphia...

A useful tool to learn how to set goals and track progress.

Keeping Track of Your Ph+ CML Treatment

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TABLE OF CONTENTS

PH+ CMLWhat is Ph+ CML? ................................................................................................. 6What are the phases of Ph+ CML? ................................................................7

Treatment GoalsHow can I use PCR testing to keep track of my treatment? ........... 9Understanding treatment milestones ........................................................10Keeping track of your milestones ................................................................13

TASIGNA® (nilotinib)TASIGNA—Your Ph+ CML treatment option ..........................................15The goal of treatment with TASIGNA ........................................................17How TASIGNA works .........................................................................................18Taking TASIGNA ................................................................................................. 20Talking to your doctor ......................................................................................24

Resources & SupportHelpful resources and support .....................................................................26Ph+ CML glossary ...............................................................................................28Indications and Important Safety Information about TASIGNA ..32Additional resources..........................................................................................38

Ph+ CML Glossary definitions for terms are highlighted in light purple and can be found on pages 28-31.

Please see Important Safety Information on pages 32-37, including Boxed WARNING, enclosed full Prescribing Information, and the TASIGNA Medication Guide.

TASIGNA® (nilotinib) Indications

TASIGNA is a prescription medicine used to treat adults who have:• Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid

leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular)

• Ph+ CML in chronic phase and accelerated phase who are no longer benefiting from, or did not tolerate, other treatment including GLEEVEC® (imatinib mesylate). The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (hematologic and cytogenetic)

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Ph+ CM

LIMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules

What is the most important information to know about prescription TASIGNA?

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.

• Your doctor should check your heart with a test called an electrocardiogram (ECG):

– Before starting TASIGNA– 7 days after starting TASIGNA– With any dose changes– Regularly during TASIGNA treatment

• Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood

• TASIGNA can interact with many medicines and supplements. This may increase your chance for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so

• Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chance for serious and life-threatening side effects. Take TASIGNA on an empty stomach. Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA

Ph+

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Understanding how Ph+ CML works can help you take an active role in treating it.

Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) is a type of cancer of the bone marrow and blood. Leukemia, which means “white blood,” is caused when your bone marrow makes too many white blood cells.

WHAT IS Ph+ CML?

Normal blood cells Blood cells in person with Ph+ CML

White blood cell Helps your body fight infection and disease

Leukemic cell Diseased white blood cell that grows abnormally

Red blood cell Transports oxygen from the lungs to the body

Platelet A clear, disk-shaped piece of a cell that forms blood clots and controls bleeding

Over time, excess white blood cells crowd out healthy red blood cells and platelets. This has negative health consequences. Note that one of the best ways to know how many leukemic cells are in the body is through a quantitative polymerase chain reaction (PCR) test, which we will review later.

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WHAT ARE THE PHASES OF Ph+ CML?

Most adults living with Ph+ CML are diagnosed in the chronic phase, which is the initial phase of the disease.

of blood cells in the bone marrow samples are blast cells

<10%of blood cells in the bone marrow samples are blast cells

10-19%of blood cells in the bone marrow samples are blast cells

>20%

• Immature white blood cells, called blast cells, begin to appear in the blood and bone marrow

• Symptoms are fairly mild, if present at all

• An increasing number of white blood cells and blast cells are present in the blood and bone marrow, with fewer normal cells present

• Abnormal platelet count (either very high or very low)

• May have fever, poor appetite, and weight loss

• A greater number of blast cells are found in the blood or bone marrow compared with the accelerated phase and begin spreading to other tissues and organs beyond the bone marrow

• Often associated with fever, poor appetite, and weight loss

Chronic Phase Accelerated Phase Blast Crisis

—

What is the International Scale (IS)? The International Scale was developed by researchers to better track treatment progress. By providing a standard for reporting PCR results, the International Scale helps assure your progress is measured consistently.

Ask your doctor about using a lab that reports PCR results based on the International Scale.


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Help guide your treatment plan by following this easy-to-remember, 3-step formula:

UNDERSTAND YOUR NUMBERS

SET YOUR GOAL

TRACK YOUR PROGRESS

Knowledge is important. Understanding your treatment results is an important part of Ph+ CML therapy.

The lower the amount of leukemic cells in your body, the better. Therefore, a major goal of Ph+ CML treatment is getting your numbers as low as possible. When this happens, it’s called a major molecular response (MMR). Only PCR testing can determine if you’ve reached MMR and are staying there.

Shoot for MMR as your main treatment goal. But if you don’t get there, it may be time to talk to your doctor again about another Ph+ CML treatment.

HOW CAN I USE PCR TESTING TO KEEP TRACK OF MY TREATMENT?

Treatment goals

After your baseline measurement, the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®) recommend PCR testing following standardization with the International Scale every 3 months, with the goal of reaching MMR at 12 months.

UNDERSTANDING TREATMENT MILESTONES

Molecular response (most sensitive measure of how much cancer has been destroyed—a PCR test can find 1 cancer cell in 1 million normal cells)

• Uses PCR test (as measured by the International Scale) to determine how many BCR-ABL cells remain in your body

• A PCR test is a very simple and precise test for measuring how many leukemic cells are in your body

• A major molecular response (MMR) means that the amount of BCR-ABL found in the bone marrow sample or blood sample is very low

There are 3 fundamental treatment milestones for Ph+ CML, each signifying a greater reduction of cancer in your body.

MolecularResponse

An MMR is a high standard of treatment success. While MMR at 12 months is an important goal of treatment for most patients, physicians will also test for lower levels of response along the way.

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Hematologic response (least sensitive measure of how much cancer has been destroyed)

• Uses a complete blood count to determine your blood cell levels

• Complete hematologic response means your blood cell levels have returned to normal

Cytogenetic response (less sensitive measure than a PCR test of how many leukemic cells have been destroyed—can find 1 leukemic cell in up to several hundred normal cells)

• Uses traditional karyotype or FISH test to determine the amount of cells containing the Ph chromosome left in the bone marrow sample or blood sample

• Complete cytogenetic response means the test can no longer detect any cells with the Ph chromosome in the bone marrow sample or blood sample

• A major cytogenetic response means that less than 35% of the cells in the bone marrow sample or blood sample have the Ph chromosome

HematologicResponse

CytogeneticResponse

If your doctor hasn’t scheduled an IS PCR test for you, ask to have one scheduled during your next visit.

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How often do I follow up?

MISSING YOURMILESTONE?

Achieving MMR by 12 months is recommended by the NCCN Guidelines. This milestone is measured by a PCR test. If you do not reach this milestone, this may mean your current treatment may not be effective enough, and you may be at risk of resistance.

KEEPING TRACK OF YOUR MILESTONES

The NCCN Guidelines® recommend a PCR test upon diagnosis and every 3 months thereafter. At 12 months of treatment, you will be tested to see if you have achieved major molecular response (MMR).

NCCN Guidelines recommend getting an IS PCR test every 3 months.


TASIGNA® (nilotinib)— YOUR Ph+ CML TREATMENT OPTION

TASIGNA is a prescription medicine used to treat adults who have:

• Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular)


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TASIG

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THE GOAL OF TREATMENT WITH TASIGNA® (nilotinib)

A key goal of treatment is to reduce or eliminate the number of cells that cause Ph+ CML.

If you have switched from another medication, like GLEEVEC® (imatinib mesylate), to TASIGNA, you may have done so because you were resistant to treatment, and may not have been hitting your treatment milestones.

It is important to continue monitoring your numbers to ensure that you maintain your response to therapy and keep the levels of BCR-ABL in your blood and bone marrow low.

Only a PCR test is sensitive enough to detect a molecular response, an important treatment response, and determine if you’re staying there.

TASIGNATASIGNA binds to

the BCR-ABL protein

BCR-ABL ProteinThis process may block the

signal that leads to the production of leukemic cells

Ph+ CMLA reduction of leukemic cells

may help provide room for healthy blood cells to grow

Make sure you take TASIGNA exactly as prescribed by your physician to help block the signal that may cause your body to produce leukemic cells.

HOW TASIGNA® (nilotinib) WORKS

TASIGNA binds to the BCR-ABL protein• May block the signal that leads to the production of leukemic cells

• Blocking the signal may lead to a reduction of leukemic cells and may help provide room for healthy blood cells to grow


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Serious side effects

TASIGNA may cause serious side effects, including:

• Low blood counts. Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include:

° Unexplained bleeding or bruising

° Blood in urine or stool

° Unexplained weakness

• QT prolongation. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation, a possible life-threatening heart problem

• Decreased blood flow to the leg, heart, or brain. People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, the heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms:

• Liver damage. Symptoms include yellow skin and eyes

• Pancreas inflammation (pancreatitis). Symptoms include sudden stomach area pain with nausea and vomiting

• Bleeding in the brain. Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious

• Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:

° Kidney failure and the need for dialysis treatment

° An abnormal heart beatYour doctor may do blood tests to check you for TLS

• Bleeding. Call your doctor right away if you develop signs and symptoms of bleeding

• Fluid Retention. Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling

° Chest pain or discomfort

° Numbness or weakness

° Problems walking or speaking

° Leg pain

° Your leg feels cold

° Change in the skin color of your leg

TAKING TASIGNA® (nilotinib)

You should avoid grapefruit products and other foods that are known to inhibit

CYP3A4

Grapefruit

If you need to take antacids (medicines to treat heartburn) do not take them

at the same time that you take TASIGNA. Take them about 2 hours before or

about 2 hours after you take TASIGNA.

AntacidsWarfarin

A single-dose study did not show a drug interaction between

TASIGNA and warfarin. Exercise caution when coadministering TASIGNA with substrates for

CYP3A4 enzymes that have a narrow therapeutic index

Antacids

Drug Interactions

CYP3A4 is an enzyme that metabolizes many medications, such as

TASIGNA. Do not take TASIGNA with CYP3A4 inhibitors or inducers,

as it may affect its concentration

TASIGNA can interact with many medicines, including prescription and non-prescription vitamins and herbal supplements, and can increase your chance for serious side effects. Know the medicines you take, keep a list of them, and show it to your doctor or pharmacist when you get a new medicine or supplement.


Take 2 capsules in the morning and

2 capsules in the evening

No Food

Missed Dose

2x2

2 2

Water

2x Day

TASIGNA doses should be taken approximately

12 hours apart

12h

If a dose is missed, you should not make up

the dose but take the next dose as scheduled

Capsules should be swallowed whole

with water

Do not take TASIGNA with food.Do not eat 2 hours

before or 1 hour after taking your dose

NO FOOD

Take 2 capsules in the morning and

2 capsules in the evening

No Food

Missed Dose

2x2

2 2

Water

2x Day

TASIGNA doses should be taken approximately

12 hours apart

12h

If a dose is missed, you should not make up

the dose but take the next dose as scheduled

Capsules should be swallowed whole

with water

Do not take TASIGNA with food.Do not eat 2 hours

before or 1 hour after taking your dose

NO FOOD

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TASIGNA should be taken twice a day, 12 hours apart. Do not eat 2 hours before or 1 hour after taking your dose.

Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you. TASIGNA is a long-term treatment. Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it. Take your dose at the same time every day.

You should check with your doctor, nurse, or pharmacist if you have any questions. Review this section in its entirety to be sure you take TASIGNA properly.

If you are unable to swallow capsules, the contents of each capsule may be dispersed in 1 teaspoon of applesauce (puréed apple) and the mixture swallowed right away (within 15 minutes).

The following is an example of a typical dosing schedule. By taking your first dose at 8:00 am, you would wait another 12 hours before taking your next dose at 8:00 pm. To prepare for your dose, you would not eat between 2 hours before and 1 hour after your dose.

FIRST DOSE

8:00AM

SECOND DOSE

8:00PM

NO FOOD:

EXAMPLE OF DOSING SCHEDULE

6:00-9:00AM 6:00-9:00PM

Taking TASIGNA twice a day as prescribed helps to ensure that the medication is always in your system.

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Use a watch with an alarm to help you take it on an empty stomach

Set your cell phone or computer to help

Get the support you need

Take TASIGNA at the same time every day

Put a check mark on your calendar

Ask a loved one to help you remember

If you take TASIGNA at the same time every day, it is likely to become part of your daily routine.

Each day, put a check mark on your calendar when you take TASIGNA. Seeing that you’re on track can help you stay on track.

Enlist a loved one to help you remember certain restrictions. For example, some foods such as grapefruit juice are known to inhibit CYP3A4, an enzyme that metabolizes many drugs, such as TASIGNA, and change the way TASIGNA is absorbed and should be avoided.

Set calendar reminders or the alarm clock function on your cell phone or computer to remind you to take your medication.

Get a stopwatch or a travel clock to count down the 2 hours since you last ate and the 1 hour until you can eat again. Because food increases the blood level of TASIGNA in your body, patients should not eat 2 hours before taking TASIGNA or 1 hour after taking TASIGNA.

To learn more, visit www.Tasigna.com.

TALKING TO YOUR DOCTOR

Good communication with your health care provider is important. The following tips can help your next appointment be productive and informative.

Bring questionsBefore your appointment, take a moment to make a list of questions you would like to discuss with your physician. It’s common to forget what you wanted to ask when you get into the exam room. Bringing a list can help you make sure you don’t leave your physician’s office with lingering concerns or questions.

Ask questionsDon’t hesitate to ask questions. Your health care team is there to help you and wants you to have a good understanding of your condition and treatment. If you feel your physician does not have time to answer questions, speak with the nurse. Nurses are a valuable resource and are there to help.

Take notesBring a pen and paper into your appointment so you can write down what your physician says. Not only can this help you remember important information, but writing things down can often spur additional questions that may help clarify your physician’s instructions.

Take someone with youSometimes it’s easier to talk with your doctor when a spouse, friend, or partner is by your side. This person can also act as the note-taker.


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Share information Chances are you are working with several doctors and health care professionals for your treatment or other health conditions. Speak with the nurse at each health care provider’s office to make sure that all your providers are sharing important information with each other. For example, make sure your primary doctor is getting test results from your specialist and vice versa.

Understand your numbersBe sure to discuss your test results with your physician and that you get a clear understanding of what they mean.

Remember your other health needs Most of your energy right now may be going into managing your Ph+ CML, but try not to neglect your other health needs. Be sure to have your blood pressure and cholesterol checked regularly and stay up-to-date on other regular health exams. Managing your disease is important, and so is managing the rest of you.

Get your questions prepared for a smarter doctor’s visitThe My Doctor Dialogue tool provides common questions and answers to many topics you may want to discuss with your doctor. Check it out at www.us.TASIGNA.com.

HELPFUL RESOURCES AND SUPPORT


The TASIGNA Dual Offer Card was created to help you save money on your TASIGNA prescriptions by providing two financial assistance options for eligible patients: a FREE 3-Month Trial and a $0 Copay Offer.

FREE 3-MONTH TRIALFor all patients who are new to TASIGNA

$O COPAY OFFERFor all commercially insured TASIGNA patients*

TASIGNA Dual Offer Card

* See TASIGNA Dual Offer Card for details. Limitations apply. See Program Terms and Conditions. This offer is not vald under Medicare, Medicaid or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice.

ALL NEW PATIENTS TO TASIGNAPATIENT INSTRUCTIONS: Call 1-877-687-9303 to activate. If you are new to TASIGNA, present this voucher to your participating pharmacist, along with a valid prescription, for a FREE 3-month supply of TASIGNA. The TASIGNA FREE 3-month supply cannot be combined with any existing offers. Follow the dosage instructions provided by your prescriber. Cardholders, please call 1-877-887-9303 with any questions.No purchase required. This free trial is not health insurance. Void where prohibited by law. Product dispensed pursuant to terms and conditions of voucher. Claim shall not be submitted to any public or private third-party payer of any federal or state health care program for reimbursement. Valid in the USA and Puerto Rico. Offer not valid if reproduced or submitted to any other payer. Prescriber ID# required on prescription. It is illegal for any person to sell, purchase or trade, or offer to sell, purchase or trade, or to counterfeit this voucher. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this offer without notice. PHARMACIST INSTRUCTIONS: This card must accompany a valid TASIGNA prescription. Please dispense at no cost to the patient. Submit claim to OPUS Heath only. Do not submit to any other payer, public or private. Direct questions to OPUS Health at 1-800-364-4767.This card is the property of the Novartis Pharmaceuticals Corporation and OPUS Health and must be returned upon request. Both parties retain the right to rescind, revoke, or amend this program without notice. Not valid if reproduced. The product is dispensed pursuant to terms of card. Void where prohibited by law.COMMERCIAL INSURANCETERMS AND CONDITIONS: Valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid or any other federal or state program, for cash-paying patients, where product is not covered by patient’s commercial insurance, or where plan reimburses you for entire cost of your prescription drug. Offer is not valid where prohibited by law. Valid only in the US and Puerto Rico. This program is only valid for those patients 18 years and older. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. This card is the property of Novartis Pharmaceuticals Corporation and must be returned upon request. Novartis reserves the right to rescind, revoke or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer. This offer expires on December 31st, 2015, except for Massachusetts residents, where offer expires on June 30, 2015.

PATIENT INSTRUCTIONS: Present this offer and your insurance card along with a valid prescription for TASIGNA at any participating pharmacy or through mail order. This offer includes a $32000 max annual cap per calendar year paid for by Novartis, not to exceed $9600 per month. If you reach the max annual cap per calendar year of $32000, you will be responsible for the difference. Offer expires 12/31/2015, except for Massachusetts residents where offer expires on 6/30/15. Patient questions should be directed to: 1-877-887-9303. When you use this offer, you are certifying that you understand the program rules, regulations, and terms and conditions, and that you will disclose and report the use of this offer as may be required by your insurer. You are not eligible if prescriptions are paid by any federal or state program, or where prohibited by law; and you will otherwise comply with the terms and conditions above.PHARMACIST INSTRUCTIONS FOR A PATIENT WITH AN ELIGIBLE THIRD PARTY: This card must accompany a valid TASIGNA prescription. Please submit the copay authorized by the patient’s primary insurance as a secondary transaction to OPUS Health. You will receive a processing fee from OPUS Health with your next remittance. Pharmacists with questions, please call OPUS Health at 1-800-364-4767.When you use this offer, you are certifying that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental programs for this prescription. Pharmacist will comply with his/her obligations when processing the prescription for payment. By using this card, you agree to the terms and conditions of this program.

Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936-1080 © 2014 Novartis Printed in USA 12/14 T-AM7-1097999

Offer expires: 12/31/2015

* Limitations apply. See Program Terms and Conditions. Novartis reserves the right to rescind, revoke, or amend this program without notice.

Eligibility: Commercially Insured PatientsBILL PRIMARY INSURANCE FIRST

If you are filling a prescription for commercial insurance patients, use these codes when submitting your claim:

COPAYFOR COMMERCIAL INSURANCE

Commercial insurance patients who are prescribed TASIGNA pay $0 out of pocket per month.*

$0Patients who are new to TASIGNA can use this card to receive a FREE 3-month supply of treatment.*

If you are filling a prescription for a patient who is new to TASIGNA, use these codes when submitting your claim:

Eligibility: Medicare/Medicaid/Cash BILL DIRECT TO OPUSHEALTH ONLY

Please see accompanying full Prescribing Information, including Boxed WARNING, and the TASIGNA Medication Guide.

3-MONTH SUPPLYOF TASIGNAFREE

RxBIN: 601341RxPCN: OHCPRxGRP: XXXXXXXXXRxID: XXXXXXXXXXXXSuf: 01

RxBIN: 601341RxPCN: OHSRxGRP: XXXXXXXXXRxID: XXXXXXXXXXXXSuf: 01

Novartis Offers Comprehensive Support

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Resources

& support

Free PCR tests

Novartis is committed to achieving the highest standard of Ph+ CML care. That’s why we’re offering free PCR testing for eligible patients through December 31, 2015.†

Talk to your doctor about access to labs that report PCR results based on the International Scale.

Take control of monitoring your treatment with IS PCR testing

Achieving a major molecular response (MMR) is a critical milestone in your treatment journey.

To measure molecular response, your doctor will order a PCR test. The National Comprehensive Cancer Network® (NCCN®) recommends that you have a PCR test following standardization with the International Scale upon diagnosis as a baseline measurement. You should then track your progress every 3 months.

To help assure your progress is measured consistently, the International Scale was developed to report PCR results.

Ask your doctor if their lab uses the International Scale when performing your PCR tests.

† Please note that while IS RQ-PCR testing is available to all patients through participating laboratories, non-US residents, patients covered under Medicare, Medicaid, or a similar state or federal program, and residents of Massachusetts and Michigan are not eligible for the Get IS RQ-PCR NOW program.

Res

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Apoptosis: The programmed death of an abnormal cell. When apoptosis is halted, this may lead to uncontrolled cell growth.

BCR-ABL: Refers to both an abnormal gene and a protein that the gene creates. The BCR-ABL gene is formed when 2 specific chromosomes combine. The gene then creates the BCR-ABL protein—the underlying cause of Ph+ CML.

Blast cell: An immature cell that matures into a blood cell.

Bone marrow: The soft, spongy inner part of bones where blood cells are made.

Cell proliferation: A rapid growth of new cells.

Chromosome: Part of the nucleus of the cell that contains the genes.

Complete blood count: A test of the blood that includes red blood cell count, white blood cell count, erythrocyte indices, hematocrit, differential blood count, and sometimes platelet count.

Cytogenetic response: A complete cytogenetic response means that, using currently available tests, no cells with the Philadelphia chromosome are found in the bone marrow sample or blood sample. However, this does not mean that your Ph+ CML is cured.

A major cytogenetic response means that less than 35% of the cells in the bone marrow sample or blood sample have the Philadelphia chromosome.

Cytogenetic testing: Tests done on bone marrow cells or white blood cells to see if they contain the Philadelphia chromosome. There are 2 types of cytogenetic testing: karyotyping and FISH (fluorescence in situ hybridization).

Ph+ CML GLOSSARY


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DNA: The organic compound inside the nucleus of a cell that carries the genetic instructions for making proteins. Genes are made of DNA.

FISH (fluorescence in situ hybridization): A sensitive test done on either blood or bone marrow cells to look for abnormal cells that contain the BCR-ABL gene (which is located on the Philadelphia chromosome). This test can find 1 abnormal cell out of 200 to 500 normal cells.

Gene: The basic unit of heredity passed from parent to child. Genes are made of DNA and carry instructions for making proteins.

Hematologic response: A complete hematologic response means white blood cell, platelet, and red blood cell counts have returned to a normal range. However, this does not mean that your Ph+ CML is cured.

Hematologic testing: A simple blood test to measure levels of white blood cells, red blood cells, and platelets.

Karyotyping: A cytogenetic test to identify chromosome abnormalities as the cause of a disease. This test looks at a small number of cells (about 20).

Major molecular response: A major molecular response means that the amount of BCR-ABL found in the bone marrow sample or blood sample through an IS PCR test is very low.

Molecular testing: The use of PCR (polymerase chain reaction) to find the number of cells expressing BCR-ABL in either blood or bone marrow.

Myelocyte: A large cell of the bone marrow that is an immature granulocyte.

PCR (polymerase chain reaction): A very sensitive test to count the number of cells containing the BCR-ABL gene (which is located on the Philadelphia chromosome). It can be done on either blood or bone marrow cells and can detect the presence of a single abnormal cell within a sample of 1 million cells.

Philadelphia (Ph) chromosome: An abnormal chromosome that is responsible for the constant production of abnormal white blood cells (myeloid cells) that are present in Ph+ CML.

Platelet: Type of blood cell that helps blood to clot.

Promyelocyte: A cell in bone marrow that is in an intermediate stage of development between a myeloblast and a myelocyte.

Protein: An essential component of all living cells that is made up of amino acids.

Red blood cell: Type of blood cell that carries oxygen to other cells in the body.

Remission: A disappearance of evidence of a disease, usually as a result of treatment.

Resistance: A primary resistance means not getting a complete hematologic response within 3 months on treatment, not getting a cytogenetic response within 6 months on treatment, or not getting a major cytogenetic response at 12 months on treatment.

A secondary resistance means that a prior hematologic or cytogenetic response that was obtained while on treatment is lost.

Ph+ CML GLOSSARY (cont)


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Side effects: A side effect, also referred to as an adverse event, is a result of drug therapy that differs from the desired effect.

Spleen: An organ that stores and filters blood.

Stem cell: An early cell that matures into various types of cells.

Stem cell transplant: Procedure used to restore bone marrow after chemotherapy by transplanting blood-forming stem cells into the patient.

Translocation: A process in which 2 or more chromosomes break, and the broken parts of the chromosomes switch places. This forms new hybrid chromosomes, often with abnormal functions.

Tyrosine kinase: A protein that facilitates the growth of Ph+ CML cells. As a treatment for Ph+ CML, medicines called tyrosine kinase inhibitors target this protein and prevent it from signaling additional cell growth.

White blood cell: Type of blood cell that fights infection.

TASIGNA PATIENT INFORMATION

TASIGNA® (nilotinib) Indications

TASIGNA is a prescription medicine used to treat adults who have:

• Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. The effectiveness of TASIGNA in these patients is based on a study that measured two types of response to treatment (cytogenetic and molecular)


INDICATIONS and IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib)

Please see enclosed full Prescribing Information, including the Boxed WARNING, and the TASIGNA Medication Guide.

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Important Safety Inform

ationIMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) Capsules

What is the most important information to know about prescription TASIGNA?

TASIGNA can cause QT prolongation, a possible life-threatening heart problem. QT prolongation causes an irregular heartbeat, which may lead to sudden death. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation.

• Your doctor should check your heart with a test called an electrocardiogram (ECG):

– Before starting TASIGNA– 7 days after starting TASIGNA– With any dose changes– Regularly during TASIGNA treatment

• Do not take TASIGNA if you have long QTc syndrome or low levels of potassium or magnesium in your blood

• TASIGNA can interact with many medicines and supplements. This may increase your chance for serious and life-threatening side effects. Do not take any other medicine while taking TASIGNA unless your doctor tells you it is okay to do so

• Food and grapefruit products increase the amount of TASIGNA in your body. This may increase your chance for serious and life-threatening side effects. Take TASIGNA on an empty stomach. Avoid eating food for at least 2 hours before the dose is taken, and avoid eating food for at least 1 hour after the dose is taken. Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA

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nINDICATIONS and IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) (cont)


Before taking TASIGNA, tell your doctor about all of your medical conditions, including if you:

• Have a heart disorder or are taking medication for the heart

• Have had a stroke or other problems due to decreased blood flow to the brain

• Have problems with decreased blood flow to your legs

• Have an irregular heartbeat

• Have QT prolongation or a family history of it

• Have liver problems

• Have had a pancreas disorder known as pancreatitis

• Know that you suffer from low blood levels of electrolytes, such as potassium or magnesium

• Have had a surgical procedure involving the removal of the entire stomach (total gastrectomy)

• Are lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA

• Have bleeding problems

• Are pregnant or plan to become pregnant. TASIGNA may harm your unborn baby. Women should not become pregnant while taking TASIGNA. Talk to your health care provider right away if you are pregnant or plan to become pregnant

• Are breastfeeding or plan to breastfeed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breastfeed. You should not do both

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

34

TASIGNA may cause serious side effects, including:

• Low blood counts: Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include:

° Unexplained bleeding or bruising

° Blood in urine or stool

° Unexplained weakness

• QT prolongation: Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation, a possible life-threatening heart problem

• Decreased blood flow to the leg, heart, or brain: People who have recently been diagnosed with Ph+ CML and take TASIGNA may develop decreased blood flow to the leg, the heart, or brain. Get medical help right away if you suddenly develop any of the following symptoms:

° Chest pain or discomfort

° Numbness or weakness

° Problems walking or speaking

° Leg pain

° Your leg feels cold

° Change in the skin color of your leg

• Liver damage: Symptoms include yellow skin and eyes

• Pancreas inflammation (pancreatitis): Symptoms include sudden stomach area pain with nausea and vomiting

INDICATIONS and IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib) (cont)

• Bleeding in the brain: Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious

• Tumor Lysis Syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:

° Kidney failure and the need for dialysis treatment

° An abnormal heart beat

Your doctor may do blood tests to check you for TLS

• Bleeding: Call your doctor right away if you develop signs and symptoms of bleeding

• Fluid Retention: Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling

Common side effects

Most patients experience side effects at some time. Some common side effects you may experience include:


° Low blood count

° Nausea

° Rash

° Headache

° Tiredness

° Itching

° Vomiting

° Diarrhea

° Cough

° Constipation

° Muscle and joint pain

° Runny or stuffy nose, sneezing, sore throat

° Fever

° Night sweats

36

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of TASIGNA. For more information, ask your doctor or pharmacist.

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.

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

• Take TASIGNA exactly as your doctor tells you to take it. Do not change your dose or stop taking TASIGNA unless your doctor tells you

• TASIGNA is a long-term treatment

• Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it

If you need to take antacids (medicines to treat heartburn) do not take them at the same time that you take TASIGNA. If you take:

• A medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take TASIGNA, or about 2 hours after you take TASIGNA

• An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take TASIGNA

Please see the full Prescribing Information, including the Boxed WARNING, and the TASIGNA Medication Guide.

ADDITIONAL RESOURCES


Novartis Patient Assistance ProgramIf you are a US resident without prescription drug coverage, you might be eligible for the Novartis Patient Assistance Program. This program helps those in financial need get access to the medications they need for treating Ph+ CML.

Copay Assistance ProgramFinancial support is made available by Independent Charitable Foundations for qualified patients who are unable to afford their copay costs. These groups include the Leukemia & Lymphoma Society and Patient Services, Inc.

To find out more about the Novartis Patient Assistance Program, please call

1-800-282-7630

To find out more about copay assistance, please call 1-866-MyCML4U (1-866-682-6548)

Get more information on these resources at www.TASIGNA.com

The organizations and websites listed under additional resources are maintained by third parties over whom Novartis Pharmaceuticals Corporation has no control. As such, Novartis Pharmaceuticals Corporation makes no representation as to the accuracy or any other aspect of the information supplied by these organizations or contained in these websites.

Other resources

American Cancer Society www.cancer.org 800-ACS-2345 (800-227-2345)

CancerCare www.cancercare.org 800-813-HOPE (800-813-4673)

Leukemia & Lymphoma Society www.LLS.org 800-955-4572

National Cancer Institute (NCI) www.cancer.gov

NCI’s Cancer Information Service www.cancer.gov/aboutnci/cis 800-4-CANCER (800-422-6237)

National Patient Advocate Foundation www.npaf.org 202-347-8009


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.

Novartis Pharmaceuticals CorporationEast Hanover, NJ 07936-1080

© 2015 Novartis Printed in USA 3/15 AM7-1110366 Printed on Recycled Paper

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