Trazimera

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Trastuzumab
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about TRAZIMERA. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking TRAZIMERA against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.

What TRAZIMERA is used for

TRAZIMERA contains an active ingredient called trastuzumab.
TRAZIMERA belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of antineoplastic agents. TRAZIMERA belongs to a class called monoclonal antibodies.
Monoclonal antibodies are proteins made in a laboratory. These proteins are designed to recognise and bind to other unique proteins in the body.
TRAZIMERA binds selectively to a protein called human epidermal growth factor receptor 2 (HER2).
HER2 is found in large amounts on the surface of some cancer cells.
When TRAZIMERA binds to HER2 it stops the growth and spread of the cancer cells.
TRAZIMERA is used to treat breast and gastric cancer. It is only used in patients whose tumour has tested positive to HER2.
TRAZIMERA may be used alone or with other medicines that treat breast cancer, such as an aromatase inhibitor (hormone receptor positive breast cancer) or a taxane (e.g. paclitaxel or docetaxel).
For the treatment of gastric cancer TRAZIMERA is used with chemotherapy medicines cisplatin and capecitabine (or 5FU).
For further information about the other medicines you are receiving with TRAZIMERA, please ask your doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) leaflet.
Ask your doctor if you have any questions about why TRAZIMERA has been prescribed for you.
This medicine is available only with a doctor's prescription.

Before you are given TRAZIMERA

When you must not be given it

Do not use TRAZIMERA if:
you have had an allergic reaction to;
any medicine containing trastuzumab
any of the ingredients listed at the end of this leaflet.
any protein of Chinese hamster origin
Some of the symptoms of an allergic reaction may include: shortness of breath; wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
you have breast cancer that has not spread (non-metastatic) and
you have had an LVEF test result (which measures how well your heart can pump blood) of less than 45% or
you have symptoms of heart failure
Symptoms of heart failure may include:
shortness of breath or tire easily after light physical activity (such as walking)
shortness of breath at night, especially when lying flat
swelling of the hands or feet due to fluid build up
abnormal or irregular heartbeat
If you are not sure whether you should start receiving this medicine, talk to your doctor.

Before you are given it

Tell your doctor if:
you have a history of heart disease with:
angina (chest pain)
cardiac arrhythmias (abnormal beating of the heart)
heart failure (where the heart cannot pump blood normally)
coronary artery disease (also known as CAD, a condition where plaque builds up inside the arteries)
poorly controlled high blood pressure
you have previously been treated with chemotherapy medicines known as anthracyclines (e.g. doxorubicin); these medicines can damage heart muscle and increase the risk of heart problems with TRAZIMERA
Your doctor will monitor your heart function closely before and during your treatment with TRAZIMERA. Your heart function may also be monitored for years after ceasing TRAZIMERA treatment.
if you have any breathing or lung problems
you are allergic to any other medicines or any other substances such as foods, preservatives or dyes
Allergic or anaphylactic reactions can occur with TRAZIMERA treatment (known as infusion or administration related reactions). Your doctor or nurse will monitor you for side effects during treatment. See "side effects" for symptoms to look out for.
you are pregnant or intend to become pregnant
TRAZIMERA may be harmful to an unborn baby. If there is a need for TRAZIMERA treatment when you are pregnant your doctor will discuss the risks and benefits to you and the unborn baby.
You should use effective contraception to avoid becoming pregnant while you are being treated with TRAZIMERA and for 7 months after stopping treatment.
you are breast-feeding or plan to breast-feed
It is not known if TRAZIMERA passes into breast milk. It is recommended that you discontinue breast-feeding while you are being treated with TRAZIMERA and not restart breast-feeding until 7 months after completing TRAZIMERA treatment.
If you have not told your doctor about any of the above, tell him/her before you start taking TRAZIMERA.

Use in children

The safety and effectiveness of TRAZIMERA in children under 18 years of age have not been established.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
TRAZIMERA treatment with gemcitabine, vinorelbine, a taxane or radiation therapy can increase the chance of lung problems (interstitial lung disease).
Your doctor and pharmacist have more information on medicines to be careful with or avoid while receiving TRAZIMERA.
Tell your doctor or pharmacist that you have had TRAZIMERA if you start any new medication in the seven months after stopping treatment.
It may take up to seven months for TRAZIMERA to be removed from your body

How TRAZIMERA is given

Follow all directions given to you by your doctor or nurse carefully.
They may differ from the information contained in this leaflet.
TRAZIMERA must be prepared by a healthcare professional and will be given in a hospital or clinic by a doctor or nurse.
TRAZIMERA is given by "drip" into a vein (intravenous (IV) infusion).
The first TRAZIMERA infusion is given over 90 minutes. If the first infusion is well tolerated, your drip time may be shortened to 30 minutes.
For the treatment of breast cancer, TRAZIMERA is given either once a week or once every three weeks. It may be given alone or in combination with other medicines used to treat breast cancer.
For the treatment of gastric cancer TRAZIMERA is given every three weeks in combination with other medicines used to treat gastric cancer.
Your doctor will decide how long you should receive TRAZIMERA, this will depend on your response to the medicine and the state of your disease.

If you miss a dose

As TRAZIMERA is given under the supervision of your doctor, you are unlikely to miss a dose. However, if you forget or miss your appointment to receive TRAZIMERA, make another appointment as soon as possible.
Your doctor will decide when and how much your next dose of TRAZIMERA will be.

If you are given too much (overdose)

As TRAZIMERA is given to you under the supervision of your doctor it is unlikely that you will be given too much. However, if you experience any side effects after being given TRAZIMERA, tell your doctor immediately.

While you are receiving TRAZIMERA

Things you must do

Tell your doctor or nurse immediately if you have any signs and symptoms of an allergic or anaphylactic reaction
Some signs and symptoms include;
swelling of your face, lips, tongue or throat with difficulty breathing,
swelling of other parts of your body
shortness of breath, wheezing or trouble breathing
rash, itching or hives on the skin
feeling sick (nausea)
fever, chills
feeling tired
headache
Tell your doctor or nurse immediately if you have any signs and symptoms of heart problems.
Some signs and symptoms of heart problems are
shortness of breath or getting tired easily after light physical activity (such as walking)
shortness of breath at night, especially when lying flat
swelling of the hands or feet due to fluid build up
cough
abnormal or irregular heartbeat
Please follow all your doctors' instructions if any of these symptoms require medication.
Tell any other doctors, dentists, and pharmacists who treat you that you are receiving TRAZIMERA.
Tell your doctor if you become pregnant or intend to start a family while receiving TRAZIMERA.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may perform regular tests.

Things you must not do

Do not stop your TRAZIMERA treatment without checking with your doctor.
Tell your doctor if you feel that
TRAZIMERA is not helping your condition.
Do not take any other medicines, whether they require a prescription or not, without first telling your doctor or consulting with a pharmacist.

Things to be careful of

Be careful driving or operating machinery until you know how TRAZIMERA affects you.
If you have experienced symptoms during your treatment with TRAZIMERA you should not drive or operate machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking TRAZIMERA.
This medicine helps most people with HER2 positive breast and gastric cancer but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Because TRAZIMERA may be used with other medicines that treat breast and gastric cancer, it may be difficult for your doctor to tell whether the side effects are due to TRAZIMERA or due to the other medicines.
For further information about the side effects of any other medicines you are receiving, please ask your doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) leaflets for these medicines

During an infusion

Tell your doctor or nurse immediately if you notice any of the following while receiving an infusion (particularly during the first infusion):
swelling of your face, lips, tongue or throat with difficulty breathing
swelling of other parts of your body such as your hands or feet
shortness of breath, wheezing or trouble breathing
abnormal or irregular heartbeat
rash, itching or hives on the skin
feeling sick (nausea) or vomiting, diarrhoea
pain or discomfort (including stomach pain, back pain, chest or neck pain)
fever or chills
headache
fatigue or tiredness
cough
These may be serious side effects. You may require urgent medical attention.
Your doctor may prescribe medication to stop the side effects from occurring.

After an infusion

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
swelling of your face, lips, tongue or throat with difficulty breathing
severe shortness of breath, wheezing or trouble breathing
severe chest pain spreading out to the arms, neck, shoulder and/or back
rash, itching or hives on the skin
fever or chills
abnormal or irregular beating of the heart
severe swelling of the hands, feet or legs
severe coughing
These are serious side effects. You may need urgent medical attention.
Tell your doctor or nurse as soon as possible if you notice any of the following:
any of the side effects listed above
getting tired more easily after light physical activity, such as walking
shortness of breath, especially when lying down or being woken from your sleep with shortness of breath
runny or blocked nose, or nosebleeds
insomnia (difficulty sleeping)
weakness, soreness in muscles and/or joints
increased cough
feeling dizzy, tired, looking pale
flu and/or cold like symptoms, frequent infections such as fever, severe chills, sore throat or mouth ulcers
hot flushes
diarrhoea
changes in weight (gain or loss)
redness, dryness or peeling of the hands or feet (hand-foot syndrome)
pain in hands or feet
unusual hair loss or thinning
nail problems
eye problems such as producing more tears, swollen runny eyes or conjunctivitis (discharge with itching of the eyes and crusty eyelids)
This is not a complete list of all possible side effects. Your doctor or pharmacist has a more complete list.
Others may occur in some people and there may be some side effects not yet known.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.

Product description

Storage

TRAZIMERA will be stored in the pharmacy or on the hospital ward in a refrigerator at a temperature between 2°C and 8°C.

Availability

TRAZIMERA is a powder for intravenous infusion (drip into the vein) and supplied as a single dose vial and available in two strengths, 60 mg and 150 mg.
It is important to check the product labels to ensure that the medicine is being given as prescribed.

What it looks like

TRAZIMERA is a white powder which is dissolved in sterile water before use.
After dissolving, the TRAZIMERA solution should appear as a clear, colourless to pale yellow-brown solution.

Ingredients

Each vial of TRAZIMERA contains 60 mg or 150 mg of the active ingredient trastuzumab.
It also contains;
histidine hydrochloride
histidine
polysorbate 20
sucrose
The trastuzumab protein is made using Chinese hamster ovary cells.

Supplier

TRAZIMERA is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free number: 1800 675 229
www.pfizer.com.au

Australian registration numbers

60mg: AUST R 304049
150mg: AUST R 304050
This leaflet was prepared in August 2019.