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Getting started on my TRAZIMERA treatment

Starting any new treatment can be a challenge – which is why it’s important for you to reach out for support. This TRAZIMERA site has been designed with exactly that in mind: to help support and inform you about the medicine you’ve been prescribed.

Be sure to read through this site to learn the basics about TRAZIMERA and remember to refer to it to help you better understand your treatment and how to cope with your condition. Also, be honest with yourself and your healthcare team about how you’re doing and speak to them when you have any questions or concerns about your treatment plan.

What is TRAZIMERA used for?

TRAZIMERA is a cancer medicine that is used to slow down the growth of specific breast cancer cells that produce large amounts of HER2 protein. It is used only for patients whose tumours are growing more rapidly than normal because of a genetic problem in the cells. This occurs in about 25 to 30% of breast cancer tumours.

If your doctor has prescribed Perjeta^® (pertuzumab) and the chemotherapy drug docetaxel in combination with TRAZIMERA, you should also read the leaflets for these medications.

Perjeta® is a registered trademark of F. Hoffmann-La Roche AG, used under license

Patients whose breast cancer tumour cells produce large amounts of the HER2 protein can use TRAZIMERA.
TRAZIMERA is used for:

• certain patients with early breast cancer:
• following surgery and after chemotherapy; or
• following surgery and with taxane and carboplatin chemotherapy
• and patients whose breast cancer has spread to other parts or organs of the body

When should TRAZIMERA be used?

Patients whose breast cancer tumour cells produce large amounts of the HER2 protein can use TRAZIMERA.

TRAZIMERA is used for:
• certain patients with early breast cancer:

• following surgery and after chemotherapy; or
• following surgery and with taxane and carboplatin chemotherapy

• patients whose breast cancer has spread to other parts or organs of the body

Patients whose breast cancer tumour cells produce large amounts of the HER2 protein can use TRAZIMERA.
TRAZIMERA is used for:

• certain patients with early breast cancer:
• following surgery and after chemotherapy; or
• following surgery and with taxane and carboplatin chemotherapy
• and patients whose breast cancer has spread to other parts or organs of the body

How does TRAZIMERA work?

TRAZIMERA is part of a family of medicines called monoclonal antibodies. Monoclonal antibodies have the ability to attach to proteins on cancer cells.

TRAZIMERA attaches to the HER2 receptor on the cancer cell, and it works to help stop the growth of the cancer cells and possibly destroy them.

What formats are available for TRAZIMERA?

TRAZIMERA is available as sterile powder to be reconstituted with a diluent.

• 150 mg vial of TRAZIMERA
• 440 mg vial of TRAZIMERA
The vial stopper is not manufactured with natural rubber latex.

How will I receive TRAZIMERA?

TRAZIMERA is given as an intravenous (IV) infusion (through a needle placed in a vein in the arm or hand).

How often will I receive TRAZIMERA?

Your registered nurse will give your dose of TRAZIMERA at regular intervals determined by your physician (usually every 3 weeks). The first time your TRAZIMERA infusion is given, it will take about 90 minutes. If you tolerate this infusion well, the following infusions after that may require less time, usually about 30 minutes. Your TRAZIMERA treatment period and how long it takes will depend on your response. Your physician will monitor your response and decide how many rounds of treatments you will receive.

How often will I receive TRAZIMERA?

Your TRAZIMERA treatment period and how long it takes will depend on your response. Your physician will monitor your response and decide how many rounds of treatments you will receive.

Serious Warnings and Precautions

MEDICATION ERRORS
There is a risk of medication errors between TRAZIMERA (trastuzumab) and Kadcyla® (trastuzumab emtansine). Verify with the healthcare provider that the recommended TRAZIMERA (trastuzumab) dose and NOT Kadcyla (trastuzumab emtansine) dose is used.

CARDIOTOXICITY (HARM TO THE HEART)
TRAZIMERA can result in the development of heart problems including heart failure.
The appearance of heart failure can be delayed and can occur after treatment with TRAZIMERA is completed. In early breast cancer, the incidence of cardiac dysfunction was higher in patients who received trastuzumab plus chemotherapy versus chemotherapy alone, with higher risk when trastuzumab was administered together with a taxane following an anthracycline and cyclophosphamide. In patients with breast cancer that has spread to other parts or organs of the body, the incidence and severity of cardiac dysfunction was particularly high in patients who received trastuzumab at the same time as anthracyclines and cyclophosphamide.
You should have your heart function evaluated by your doctor before and during treatment with TRAZIMERA.

INFUSION REACTIONS; LUNG PROBLEMS
Some patients have had serious infusion reactions and lung problems; infusion reactions causing death have been reported. In most cases, these reactions occurred during or within 24 hours of receiving trastuzumab. Your TRAZIMERA infusion should be temporarily stopped if you have shortness of breath or very low blood pressure. Your doctor will monitor you until these symptoms go away. If you have a severe allergic reaction, swelling, lung problems, inflammation of the lung, or severe shortness of breath, your doctor may need to completely stop your TRAZIMERA treatment.

TOXICITY TO FETUS (UNBORN BABY)
TRAZIMERA can cause harm to the fetus (unborn baby), in some cases death of the fetus, when taken by a pregnant woman. Women who could become pregnant need to use effective birth control methods during TRAZIMERA treatment and for at least 7 months after treatment with TRAZIMERA. Nursing mothers treated with TRAZIMERA should discontinue nursing or discontinue TRAZIMERA.

What should I know before I take TRAZIMERA?

Important safety information

What should I know before I take TRAZIMERA?

Do not use TRAZIMERA if you are allergic to trastuzumab, Chinese Hamster Ovary cell proteins, or any of its ingredients. If your doctor has prescribed Perjeta® (pertuzumab) and the chemotherapy drug docetaxel in combination with TRAZIMERA, you should also read the leaflets for these medications.

TRAZIMERA has a minor influence on the ability to drive and use machines. Dizziness and sleepiness may occur during treatment with TRAZIMERA. If you experience unwanted effects related to the infusion (such as itching, wheezing, dizziness, or racing heart) you should not drive or operate machinery until symptoms resolve completely.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRAZIMERA. Talk about any health conditions or problems you may have, including if you:

• have ever had a bad reaction to TRAZIMERA, benzyl alcohol, or any of the inactive ingredients
• are allergic to other medicines, food and dyes
• are taking any other medicines, including those not prescribed by your doctor
•have any other illness or diseases, such as heart problems, heart disease, breathing problems or lung disease; the risk of heart problems may be increased in geriatric patients in both early breast cancer and breast cancer that has spread to other parts or organs of the body; the risk of lung disease may increase if you have taken chemotherapy drugs which are toxic for the lungs
•have already been treated with chemotherapy drugs (especially anthracyclines such as doxorubicin, epirubicin or related drugs such as mitoxantrone) or radiation therapy
•are pregnant, plan to become pregnant or are breast-feeding a child. Please note that a reduction in the amount of amniotic fluid has been observed in pregnant women receiving trastuzumab
•have difficulty breathing at rest

What are the possible side effects of TRAZIMERA?

Important safety information

What are the possible side effects of TRAZIMERA?

These are not all the possible side effects that you may feel when taking TRAZIMERA. If you experience any side effects not listed here, contact your healthcare professional.

Unwanted effects are possible with all medicines. Talk to your doctor, nurse or pharmacist if you are worried about side effects or find them very bothersome, and report any new or continuing symptoms to your doctor immediately. Your doctor will be able to tell you what to do and may be able to help you with these side effects.

Some unwanted effects happen during the first infusion or shortly after it is completed. The effects usually do not last long but may need treatment. The infusion may be stopped, and may be restarted and/or given over a longer time.

These unwanted effects related to the infusion may include:

• Itching
• Wheezing
• Dizziness
• Racing heart

Giving certain medications before the next infusion of TRAZIMERA may prevent these unwanted effects.

In clinical studies, the most common unwanted effects were fever and chills, nausea, vomiting, diarrhea, pain, and headache. The symptoms can easily be treated. Giving certain medications before TRAZIMERA can prevent some unwanted effects.

Less common unwanted effects are:

• Shortness of breath and water retention, which are symptoms of heart problems. These are caused by an effect on the heart muscle that reduces the strength of the pumping action of the heart. This unwanted effect is more common in women who have previously had anthracycline chemotherapy (e.g. doxorubicin, epirubicin). Heart failure as a result of TRAZIMERA treatment can vary in severity and may require treatment with heart medications and/or TRAZIMERA treatment may need to be stopped.
• Shortness of breath, fatigue, or a racing heart, which are symptoms of anemia. This is caused by a temporary decrease in the number of red blood cells.
• A temporary decrease in the number of white blood cells may increase your risk of infection and diarrhea.

Difficulty breathing, fatigue and weight loss are commonly seen with lung disease.

Call your doctor immediately if you notice any of the following:

• Shortness of breath
• Increased cough
• Swelling of the legs as a result of water retention
• Diarrhea – if you have an extra four bowel movements each day or any diarrhea at night
• Symptoms of infection that include:
• Fever (a temperature of 38°C or greater)
• Sore throat
• Cough
• Any redness or swelling
• Pain when you pass urine
• Symptoms of an allergic reaction that include:
• Closing of the throat
• Swelling of lips and tongue
• Hives
• Rash
• Dizziness
• Fast heartbeat

For more information on possible side effects of TRAZIMERA, please refer to the Package Insert provided by your healthcare team.

Preparing for my next appointment

It’s important to ask questions and let your healthcare team know if you have any concerns about your treatment.

It’s always good to keep a notebook handy so you can write down any questions or concerns that you would like to talk to your healthcare team about.

Support may help

Support may help you navigate your treatment experience. If you’d like to join a support group, ask your healthcare team if there’s one in your area.

Additional resources
Canadian Cancer Society
The Canadian Cancer Society (CCS) is a national, community-based organization that provides information and support services to patients and families affected by cancer. The CCS’ online community – Cancerconnection.ca – is a place where patients and families affected by cancer can share their experiences and build supportive relationships. No matter where you are, you can connect with others online and know that you are not alone. Visit www.cancerconnection.ca or www.cancer.ca, or call 1-888-939-3333

Breast Cancer Society of Canada
The Breast Cancer Society of Canada is a registered national non-profit charity dedicated to saving lives through research for the diagnosis, treatment and prevention of breast cancer.

Visit www.bcsc.ca or call 1-800-567-8767

Rethink Breast Cancer
Rethink Breast Cancer brings bold, relevant awareness to foster a new generation of young and influential breast cancer supporters and, most importantly, respond to the unique needs of young women living with breast cancer.

Visit www.rethinkbreastcancer.com or call 416-220-0700

Canadian Breast Cancer Network
The Canadian Breast Cancer Network strives to voice the views and concerns of breast cancer patients through education, advocacy activities, and the promotion of information sharing.

Visit www.cbcn.ca or call 1-800-685-8820

The suggested resources on this page do not imply an endorsement of or association with third-party organizations and are provided for information purposes only. Pfizer is not responsible for content of non-Pfizer sites.

Support may help

Support may help you navigate your treatment experience. If you’d like to join a support group, ask your healthcare team if there’s one in your area.

Pfizer Liaison Patient Support Program

Connecting you to resources that support your treatment and complement the care provided by your healthcare team

• Reimbursement navigation and assessment
• Coordination of insurance benefits
• Financial assistance*
• Treatment information

To enroll into Pfizer Liaison, contact us by phone, 1-844-533-0150; fax, 1-844-533-1151; or email, [email protected].

* Financial assistance cannot be guaranteed.

Pfizer Liaison Patient Support Program

Connecting you to resources that support your treatment and complement the care provided by your healthcare team

• Reimbursement navigation and assessment
• Coordination of insurance benefits
• Financial assistance*
• Treatment information

To enrol into Pfizer Liaison, contact us by: phone,
1-844-616-6888 (toll-free); fax, 1-844-636-6888; or
email, [email protected].

* Financial assistance cannot be guaranteed.

Additional resources

Canadian Cancer Society
The Canadian Cancer Society (CCS) is a national, community-based organization that provides information and support services to patients and families affected by cancer.

The CCS’ online community – Cancerconnection.ca – is a place where patients and families affected by cancer can share their experiences and build supportive relationships. No matter where you are, you can connect with others online and know that you are not alone.

Visit www.cancerconnection.ca or www.cancer.ca or call 1-888-939-3333.

Breast Cancer Society of Canada
The Breast Cancer Society of Canada is a registered national non-profit charity dedicated to saving lives through research for the diagnosis, treatment, and prevention of breast cancer.

Visit www.bcsc.ca or call 1-800-567-8767.

Rethink Breast Cancer
Rethink Breast Cancer brings bold, relevant awareness to foster a new generation of young and influential breast cancer supporters and, most importantly, respond to the unique needs of young women living with breast cancer.

Visit www.rethinkbreastcancer.com or call 416-220-0700.

Canadian Breast Cancer Network
The Canadian Breast Cancer Network strives to voice the views and concerns of breast cancer patients through education, advocacy activities, and the promotion of information sharing.

Visit www.cbcn.ca or call 1-800-685-8820.

The suggested resources on this page do not imply an endorsement of or an association with third-party organizations and are provided for information purposes only. Pfizer is not responsible for content of non-Pfizer sites.

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