100276 004 tbtrz downloadable patient brochure v15 · 2020-01-29 · (anthracycline). in a study of...

UNDERSTANDING TREATMENT

A G U I D E F O R G E T T I N G S TA R T E D

WITH HERZUMA

Please see Important Safety Information throughout and full Prescribing Information, including BOXED WARNINGS, to discuss with your doctor.

https://herzuma.com/globalassets/herzuma-consumer/pdfs/herzuma-prescribing-information.pdf

HER2+ = Human Epidermal growth factor Receptor 2-positive.

APPROVED USES (continued)ntPatients are selected for therapy with HERZUMA based on an FDA-approved test.

Metastatic Breast CancerHERZUMA has 2 approved uses in metastatic breast cancer: • HERZUMA in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer • HERZUMA alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

IMPORTANT SAFETY INFORMATIONHERZUMA can cause serious side effects, including:

• HEART PROBLEMS: Trastuzumab products can cause heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both a trastuzumab product and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your healthcare provider will check for signs of heart problems before, during, and after treatment with HERZUMA

APPROVED USESPatients are selected for therapy with HERZUMA based on an FDA-approved test.

Adjuvant Breast Cancer

HERZUMA is a prescription medicine used for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature. HERZUMA can be used in several different ways: • As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC TH” • With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH” • Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy)

See Approved Uses statement continued on next page.

B E I N G D I A G N O S E D W I T H C A N C E R C A N B E

O V E R W H E L M I N G . L E A R N I N G M O R E A B O U T

W H AT C A N B E D O N E T O T R E AT I T M AY

H E L P Y O U B E P R E PA R E D.

WHAT IS HERZUMA?

HERZUMA is a prescription drug used in adults to treat HER2+ breast cancer. HERZUMA is not chemotherapy, though it is sometimes used with chemotherapy. HERZUMA is a type of treatment called an antibody therapy. This means HERZUMA is able to treat HER2+ breast cancer cells, which can multiply rapidly.

GET TO KNOW

HERZUMAH E R Z U M A M AY W O R K T O T R E AT H E R 2 + B R E A S T C A N C E R I N T H E F O L L O W I N G W AY S :

B I O L O G I C S A N D B I O S I M I L A R SBiologics are complex drugs produced from living cells.

Biosimilars are FDA-approved biological products that are highly similar to and have no clinically meaningful differences from existing FDA-approved biologic drugs.

HERZUMA is a biosimilar to Herceptin® (trastuzumab) for HER2+ breast cancer.

HERZUMA may also harm some healthy cells in the body. Talk to your doctor about any concerns you may have.

– By telling the immune system it’s okay to destroy cancer cells

– By binding to the HER2 receptor on cancer cells


Whether you are getting ready to start treatment for HER2+ breast cancer with HERZUMA or you are considering it, this guide can help you:

GET THE FACTS about HERZUMA and how it may help

UNDERSTAND why your doctor may prescribe HERZUMA

LEARN what to expect from treatment with HERZUMA

F IND OUT about helpful resources

– By destroying cancer cells on its own




YOUR DOCTOR MAY PRESCRIBE HERZUMA TO TREAT YOUR HER2+ BREAST CANCER


ABOUT HER2+ BREAST CANCER

APPROVED USESntHERZUMA is used for the treatment of adjuvant breast cancer and metastatic breast cancer in patients selected for therapy based on an FDA-approved test.

See complete indication on pages 2-3.

IMPORTANT SAFETY INFORMATION (continued)HERZUMA can cause serious side effects, including:

• INFUSION REACTIONS: Infusion reactions, sometimes serious or fatal, have occurred. Symptoms may include: fever, chills, feeling sick to your stomach (nausea), throwing up (vomiting), pain (in some cases at tumor site), headache, dizziness, and shortness of breath. These symptoms usually happen within 24 hours after receiving HERZUMA

TREATMENT GOALS

WHAT IS HER2+ BREAST CANCER?Breast cancer happens when cells in the breast grow out of control. These cells often form a tumor that can be felt as a lump. The tumor can be benign (not cancerous) or malignant (cancerous).

When you are diagnosed with breast cancer, your doctor will order tests to learn more about how the cancer should be treated. One of those tests will assess the HER2 status of your tumor.

HER2 is a protein on the outside of all cells in the breast. HER2+ cancer cells have higher than normal levels of HER2. HER2+ cancer cells tend to grow and spread faster (metastasize) than other types of breast cancer.

A N E S T I M AT E D 1 I N 5 W O M E N W I T H B R E A S T C A N C E R W I L L B E H E R 2 +


TREATMENT OPTIONS

THE APPROPRIATE TREATMENT FOR YOU DEPENDS ON:

H E R 2+ B R E A S T C A N C E RTreatments for breast cancer can include surgery, radiation, chemotherapy, hormone therapy, or immunotherapy. However, for HER2+ breast cancer, a therapy called targeted therapy is often recommended. Treatments for HER2+ breast cancer target the HER2+ protein.

P L E A S E TA L K W I T H Y O U R D O C T O R A B O U T T H E S E A N D O T H E R T R E AT M E N T O P T I O N S

H O W FA S T T H E C A N C E R I S G R O W I N G

T H E S TA G E O F T H E C A N C E R

Y O U R P E R S O N A L C H A R A C T E R I S T I C S S U C H A S A G E A N D O V E R A L L H E A LT H

SYMPTOMS OF HER2+ BREAST CANCER

GOALS FOR TREATMENT

When treatment is needed, your healthcare team will talk with you about options and come up with a treatment plan that’s right for you. Some goals when treating HER2+ breast cancer may be to help:

– Keep the disease from advancing

– Put the disease into remission

WHAT IS HER2+ BREAST CANCER?Breast cancer happens when cells in the breast grow out of control. These cells often form a tumor that can be felt as a lump. The tumor can be benign (not cancerous) or malignant (cancerous).

When you are diagnosed with breast cancer, your doctor will order tests to learn more about how the cancer should be treated. One of those tests will assess the HER2 status of your tumor.

HER2 is a protein on the outside of all cells in the breast. HER2+ cancer cells have higher than normal levels of HER2. HER2+ cancer cells tend to grow and spread faster (metastasize) than other types of breast cancer.

A N E S T I M AT E D 1 I N 5 W O M E N W I T H B R E A S T C A N C E R W I L L B E H E R 2 +

A new lump or mass on the breast is the most common symptom of breast cancer. They can be hard, irregular, and painless, or soft, round, and painful. Other possible symptoms include:

• Swelling in the breast

• Skin changes on the breast or nipple including irritation, dimples, redness, scaliness, or thickening

• Painful breast or nipples

• Nipple turning inward

• Fluid discharge from the nipple

• Lump or swelling around lymph nodes under the arm or around the collar bone


TREATMENT OPTIONS

THE APPROPRIATE TREATMENT FOR YOU DEPENDS ON:



HERZUMA is a prescription medicine used for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature. HERZUMA can be used in several different ways:

• As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC TH”

• With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH”• Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based

therapy (a type of chemotherapy)

H E R 2+ B R E A S T C A N C E RTreatments for breast cancer can include surgery, radiation, chemotherapy, hormone therapy, or immunotherapy. However, for HER2+ breast cancer, a therapy called targeted therapy is often recommended. Treatments for HER2+ breast cancer target the HER2+ protein.

P L E A S E TA L K T O Y O U R D O C T O R A B O U T T H E S E A N D O T H E R T R E AT M E N T O P T I O N S

H O W FA S T T H E C A N C E R I S G R O W I N G

T H E S TA G E O F T H E C A N C E R

Y O U R P E R S O N A L C H A R A C T E R I S T I C S

S U C H A S A G E A N D O V E R A L L H E A LT H

STARTING HERZUMA

STA R T I N G T R E AT M E N T F O R H E R 2 + B R E A ST C A N C E R

C A N L E AV E YO U W O N D E R I N G W H AT Q U E ST I O N S

TO A S K N E X T. T H E I N F O R M AT I O N I N T H I S S E C T I O N

M AY H E L P YO U G E T T H E A N S W E R S YO U N E E D.



B E F O R E R E C E I V I N G H E R Z U M A T E L L Y O U R D O C T O R I F Y O U :


• SEVERE LUNG PROBLEMS: Trastuzumab product use can result in serious and fatal lung problems. Symptoms may include: severe shortness of breath, fluid in or around the lungs, weakening of the valve between the heart and lungs, not enough oxygen in the body, swelling of the lungs, and scarring of the lungs. Your healthcare provider may check for signs of severe lung problems

WHAT YOU SHOULD TELL YOUR DOCTOR BEFORE STARTING HERZUMA

– Have trouble with your heart. HERZUMA can cause heart problems in some patients

– Are pregnant or plan to become pregnant. Trastuzumab products can cause fetal harm when administered to a pregnant woman. Because trastuzumab stays in the body for a long time, you should avoid becoming pregnant for 7 months after discontinuing HERZUMA

– Are taking any other medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements

– Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine. Do not take any new medicine without speaking with your doctor

APPROVED USES (continued)Patients are selected for therapy with HERZUMA based on an FDA-approved test.

Metastatic Breast Cancer

HERZUMA has 2 approved uses in metastatic breast cancer:

• HERZUMA in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer

• HERZUMA alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease










Your healthcare team will monitor your heart for potential cardiac issues to catch them early on so they can be properly treated.

Your heart will be monitored at the start of treatment, every 3 months while on HERZUMA therapy, and every 6 months for at least 2 years following completion of HERZUMA as a component of adjuvant therapy. Heart function will be tested with an ECHO or MUGA scan.*†

D U R I N G H E R Z U M A T H E R A P Y

– Pausing HERZUMAIn case of reduced heart function, your doctor may hold HERZUMA therapy up to 3 times

– Restarting HERZUMAYour doctor may restart HERZUMA therapy up to 3 times if your heart function improves and returns to normal limits after HERZUMA has been held

– Discontinuing HERZUMAHERZUMA will be discontinued if you experience congestive heart failure or significantly reduced heart function (when the heart can’t keep up with the amount of blood flowing through it)

A F T E R H E R Z U M A T H E R A P Y

Your heart should be monitored every 6 months for at least 2 years

*ECHO scan is an ultrasound image of the heart.† MUGA scan takes a moving picture of your heart pumping blood following an injection of a nontoxic radioactive substance.

WHY IS HEART MONITORING NECESSARY WHILE RECEIVING HERZUMA THERAPY?



• HARM TO UNBORN BABIES OR BIRTH DEFECTS: Trastuzumab products may result in birth defects or the death of an unborn baby. Contraception should be used while receiving HERZUMA and for 7 months after your last dose of HERZUMA. If you are or become pregnant while receiving HERZUMA or within 7 months after your last dose of HERZUMA, you should immediately contact your doctor. Patients should contact their healthcare professional with a known or suspected pregnancy


Use this list to help prepare yourself before every infusion:

P L A N T R A N S P O R TAT I O N T O A N D F R O M Y O U R I N F U S I O N A P P O I N T M E N T

You may feel exhausted after your infusion, so having someone else drive you home after treatments is a good idea.

B R I N G S O M E T H I N G T O PA S S T H E T I M E

A day at the clinic can be long. Reading magazines, completing a word search, or enjoying a similar activity can help you occupy the time.

B R I N G F O O D A N D B E V E R A G E S

You may be at the clinic for most of the day, so pack some snacks or a light meal and bring a water bottle.

T E L L Y O U R D O C T O R O R N U R S E A B O U T M E D I C I N E S Y O U A R E TA K I N G

If you take any other medicines, tell your doctor or nurse. Do not start any new medications without talking to your doctor. Your doctor may give you special instructions for your infusion day.

S P E A K U P

Tell your doctor or nurse about any concerns you have.

1

2

3

4

5

H O W C A N Y O U G E T R E A DY F O R Y O U R H E R Z U M A I N F U S I O N ?



• LOW WHITE BLOOD CELL COUNTS: Low white blood cell counts (which may be life-threatening) were seen more often in patients receiving trastuzumab plus chemotherapy than in patients receiving chemotherapy alone. Your healthcare provider may check for signs of low white blood cell counts

WILL YOU HAVE TO TAKE ANY MEDICINE BEFO RE YOU RECEIVE HERZUMA?

– Your healthcare provider may prescribe medicines before each infusion of HERZUMA to reduce infusion side effects such as fever and chills

– Taking the suggested medication before treatment may reduce the chance of having a severe reaction during the first HERZUMA infusion

– Be sure to ask your doctor or nurse about what you should take before HERZUMA treatment

H O W W I L L YO U R D O C TO R C H E C K U P O N YO U D U R I N G T R E AT M E N T ?

– Your doctor should do blood tests and monitor your heart regularly to check for side effects to HERZUMA

– Before each HERZUMA treatment, your healthcare provider will ask you questions about your general health. Tell your healthcare provider about any new symptoms

H O W W I L L YO U R E C E I V E H E R Z U M A?

– HERZUMA is given by infusion through a needle placed in a vein (intravenous infusion) in your arm, or through a port

– Talk to your doctor to find out whether you will receive HERZUMA in an infusion center or in your doctor’s office

– The first dose of HERZUMA takes about 90 minutes. After that, the other doses of HERZUMA only take about 30 minutes


IT CAN BE DIFFICULT TO KNOW THE RIGHT QUESTIONS to ask your doctor after being diagnosed with HER2+ breast cancer or being prescribed HERZUMA. While you may have already talked with your doctor about some of these topics, the questions that follow can be a good way to start or continue those conversations.

QUESTIONS FOR YOUR DOCTOR


IMPORTANT SAFETY INFORMATION (continued)Your healthcare provider will stop treatment with HERZUMA if you have severe, serious, or life-threatening side effects.

The most common side effects for patients receiving HERZUMA for breast cancer include: headache, diarrhea, feeling sick to your stomach (nausea), chills, fever, infection, weakened heart muscle, unable to sleep, cough, and rash.

These are not all of the possible side effects with HERZUMA.

Please see the HERZUMA full Prescribing Information, including BOXED WARNINGS.

Talk to your doctor about any side effects you may experience.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Teva at 1-888-483-8279.


WHAT STAGE OF HER2+ BREAST CANCER DO I HAVE?

WHAT ARE MY TREATMENT OPTIONS?

WHAT ARE THE POSSIBLE RISKS AND SIDE EFFECTS OF

HER2+ BREAST CANCER TREATMENT OPTIONS?

WHAT IS MY TREATMENT PL AN?

WHERE CAN I GET MORE INFORMATION ABOUT MY

TREATMENT OPTIONS AND HER2+ BREAST CANCER?

WH Y HAV E I BEEN PRESCRIBED HER ZUMA?

WHAT ARE S IDE EFFEC TS OF HER ZUMA?

WHAT ARE POSSIBLE R ISKS AND BENEFITS

OF HER ZUMA?

HOW LONG WILL I NEED TO TAK E HER ZUMA?

WHICH PROGR AMS C AN HELP ME SAV E ON

THE COS T OF HER ZUMA?

QUESTIONS ABOUT HER2+ BREAST CANCER: QUESTIONS ABOUT HERZUMA:

EXAMPLE QUESTIONS TO ASK YOUR DOCTOR










HAVING AN ILLNESS IS HARD.

Figuring out insurance benefits and financial assistance can make it harder. With our Comprehensive Oncology Reimbursement Expertise (CORE) program, we can help you understand your insurance benefits and may be able to help you find financial assistance for your treatment.


• SEVERE LUNG PROBLEMS: Trastuzumab product use can result in serious and fatal lung problems. Symptoms may include: severe shortness of breath, fluid in or around the lungs, weakening of the valve between the heart and lungs, not enough oxygen in the body, swelling of the lungs, and scarring of the lungs. Your healthcare provider may check for signs of severe lung problems

• HARM TO UNBORN BABIES OR BIRTH DEFECTS: Trastuzumab products may result in birth defects or the death of an unborn baby. Contraception should be used while receiving HERZUMA and for 7 months after your last dose of HERZUMA. If you are or become pregnant while receiving HERZUMA or within 7 months after your last dose of HERZUMA , you should immediately contact your doctor. Patients should contact their healthcare professional with a known or suspected pregnancy

• LOW WHITE BLOOD CELL COUNTS: Low white blood cell counts (which may be life-threatening) were seen more often in patients receiving trastuzumab plus chemotherapy than in patients receiving chemotherapy alone. Your healthcare provider may check for signs of low white blood cell counts

SUPPORT AND SAVINGS

FOR HERZUMAO U R C O R E P R O G R A M C A N

H E L P Y O U G E T S TA R T E D


APPROVED USES (continued)Patients are selected for therapy with HERZUMA based on an FDA-approved test.

Metastatic Breast Cancer

HERZUMA has 2 approved uses in metastatic breast cancer:

• HERZUMA in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer

• HERZUMA alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease

IMPORTANT SAFETY INFORMATIONHERZUMA can cause serious side effects, including:

• HEART PROBLEMS: Trastuzumab products can cause heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both a trastuzumab product and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your healthcare provider will check for signs of heart problems before, during, and after treatment with HERZUMA

• INFUSION REACTIONS: Infusion reactions, sometimes serious or fatal, have occurred. Symptoms may include: fever, chills, feeling sick to your stomach (nausea), throwing up (vomiting), pain (in some cases at tumor site), headache, dizziness, and shortness of breath. These symptoms usually happen within 24 hours after receiving HERZUMA





THE CORE PROGRAMT E V A O F F E R S A R A N G E O F S E R V I C E S

T H R O U G H T H E C O M P R E H E N S I V E O N C O L O GY

R E I M B U R S E M E N T E X P E R T I S E ( C O R E ) P R O G R A M .

– Benefits verification and coverage determination

– Support for precertification and prior authorization

– Teva Cares Foundation patient assistance program referrals

H E L P I N G PAT I E N T S I S AT T H E C O R E O F W H AT W E D O

See if you are eligible to save on HERZUMA, and get insurance and reimbursement information.

To learn more

VISIT TevaCORE.com

CALL 1-888-587-3263

Monday–Friday, 9 AM–6 PM (EST)

HELPFUL RESOURCESCANCER ORGANIZATIONS

AMERICAN CANCER SOCIETY 1-800-ACS-2345 (1-800-227-2345) www.cancer.org

CANCERCARE 1-800-813-HOPE (1-800-813-4673) www.cancercare.org

NATIONAL CANCER INSTITUTE 1-800-4-CANCER (1-800-422-6237) www.cancer.gov

BREAST CANCER ORGANIZATIONS

LIVING BEYOND BREAST CANCER 1-855-807-6386 www.lbbc.org

METASTATIC BREAST CANCER NETWORK 1-888-500-370 www.mbcn.org

SUPPORT ORGANIZATIONS

CANCER HOPE NETWORK 1-877-HOPENET (1-877-467-3638) www.cancerhopenetwork.org

PATIENT ADVOCATE FOUNDATION 1-800-532-5274 www.patientadvocate.org

This is a list of sources that you may find helpful. Please note that this information was accurate at the time of publication, but is subject to change without notice. Ask your healthcare team to recommend additional resources.

TERMS AND CONDITIONS

The HERZUMA Cost Support Program helps commercially insured patients in the United States (including the United States territories) who are prescribed HERZUMA pay for their eligible out-of-pocket costs for the drug. The Program does not cover the costs of physician office visits or evaluations, blood work or other testing, or transportation. See complete Terms and Conditions at HERZUMASavingsOffer.com. Eligible Patients must have commercial insurance coverage for HERZUMA. Uninsured and cash-paying patients are NOT eligible for this Program. Patients enrolled in any state or federally funded healthcare program are NOT eligible for this Program, nor are patients with commercial insurance coverage that does not provide coverage for HERZUMA. Call for more information: 1-888-587-3263.

UP TO $25,000 PER YEAR*

* The HERZUMA Cost Support Program helps commercially insured individuals.$0

ELIGIBLE PATIENTS PAY AS

LITTLE AS

IMPORTANT SAFETY INFORMATION (continued)Your healthcare provider will stop treatment with HERZUMA if you have severe, serious, or life-threatening side effects.

The most common side effects for patients receiving HERZUMA for breast cancer include: headache, diarrhea, feeling sick to your stomach (nausea), chills, fever, infection, weakened heart muscle, unable to sleep, cough, and rash.


https://www.tevacore.com/

https://herzuma.com/globalassets/herzuma-consumer/pdfs/herzuma-cost-support-program-terms-and-conditions.pdf

HERZUMA® is a registered trademark of Celltrion Inc., used under license. Herceptin® is a registered trademark of Genentech USA, Inc.©2020 Teva Pharmaceuticals USA, Inc. TRA-40068 January 2020

IMPORTANT SAFETY INFORMATION (continued)These are not all of the possible side effects with HERZUMA.

Please see the HERZUMA full Prescribing Information, including BOXED WARNINGS.

Talk to your doctor about any side effects you may experience.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Teva at 1-888-483-8279.

Models appearing in all images within this brochure depict an actor portrayal.


T H I S B R O C H U R E C O N TA I N S I M P O R TA N T I N F O R M AT I O N F O R YO U R T R E AT M E N T. B E S U R E TO :

- Check out TevaCORE.com for potential savings on HERZUMA and get information about insurance and reimbursement

YOUR GUIDE TO TREATMENT WITH HERZUMA


https://www.tevacore.com/

100276 004 tbtrz downloadable patient brochure v15 · 2020-01-29 · (anthracycline). in a study of...

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