HERZUMA®
Powder for Injection for Intravenous (IV) Infusion

Contains the active ingredient trastuzumab (rch)


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about HERZUMA. 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 being given HERZUMA against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What HERZUMA is given for

HERZUMA contains the active ingredient called trastuzumab.

HERZUMA belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of anti-neoplastic agents. HERZUMA 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.

HERZUMA 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 HERZUMA binds to HER2 it stops the growth and spread of the cancer cells.

HERZUMA is used to treat breast and gastric cancer. It is only used in patients whose tumour has tested positive to HER2.

HERZUMA 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 HERZUMA is used with chemotherapy medicines cisplatin and capecitabine (or 5FU).

For further information about the other medicines you are receiving with HERZUMA, please ask your doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) leaflet.

Ask your doctor if you have any questions why HERZUMA has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you are given HERZUMA

When you must not be given it

Do not use HERZUMA if:

  • you have had an allergic reaction to;
    – HERZUMA
    – any ingredients listed at the end of this leaflet or
    – any protein of Chinese hamster origin

    Some symptoms of an allergic reaction may include shortness of breath; wheezing or difficulty breathing; rash, itching or hives on the skin or swelling of the face, lips, tongue or other parts of the body.
  • 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 if you should start receiving HERZUMA, 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 HERZUMA
    Your doctor will monitor your heart function closely before and during your treatment with HERZUMA. Your heart function may also be monitored for years after ceasing HERZUMA treatment.
  • If you 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 HERZUMA 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
    HERZUMA may be harmful to an unborn baby. If there is a need for HERZUMA 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 HERZUMA and for 7 months after stopping treatment.
  • you are breast feeding or plan to breast feed.
    It is not known if HERZUMA passes into breast milk. It is recommended that you discontinue breast feeding while you are treated with HERZUMA and not restart breast-feeing until 7 months after completing HERZUMA treatment. .

If you have not told your doctor about any of the above, tell them before you are given HERZUMA.

Use in children

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

Taking other medicines

Tell your doctor if you are taking any other medicines including any that you have bought without a prescription from a pharmacy, supermarket or health food shop.

HERZUMA 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 HERZUMA.

Tell your doctor or pharmacist that you have had HERZUMA if you start any new medication in the seven months after stopping treatment. It may take up to seven months for HERZUMA to be removed from your body.

How HERZUMA is given

Follow all directions given to you by your doctor or nurse carefully. They may differ from the information contained in this leaflet. HERZUMA must be prepared by a healthcare professional and will be given in a hospital or clinic by a doctor or nurse.

HERZUMA is given by "drip" into a vein (intravenous (IV) infusion).

The first HERZUMA 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, HERZUMA 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 HERZUMA is given every three weeks in combination with other medicines used to treat gastric cancer.

Your doctor will decide how long you should receive HERZUMA, this will depend on your response to the medicine and the state of your disease.

If you miss a dose

As HERZUMA 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 HERZUMA, make another appointment as soon as possible.

Your doctor will decide when and how much your next dose of HERZUMA will be.

If you are given too much (overdose)

As HERZUMA 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 HERZUMA, tell your doctor immediately.

While you are receiving HERZUMA

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 all doctors, dentists and pharmacists who are treating you that you are receiving HERZUMA.

Tell your doctor if you become pregnant or intend to start a family while receiving HERZUMA.

Be sure to keep all of your appointments with your doctor so that your progress can be checked. Your doctor may perform regular tests.

Things you must not do

Do not stop your HERZUMA treatment without talking to your doctor first.

Tell your doctor if you feel that HERZUMA 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 HERZUMA affects you. If you experienced symptoms during your treatment with HERZUMA 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 receiving HERZUMA.

HERZUMA helps most people with HER2 positive breast and gastric cancer but it may have some 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 treatment if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Because HERZUMA 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 HERZUMA 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, diarrhea
  • pain or discomfort (including stomach pain, back pain, chest or neck pain)
  • fever or chills
  • headache
  • fatigue or tiredness
  • cough

These may be serious 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 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
  • sever swelling of the hands, feet or legs
  • severe coughing

These may be 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
  • hot flushes
  • diarrhea
  • 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

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

Availability

HERZUMA is available in one type (formulation);

  • Powder for intravenous infusion (drip into the vein). Supplied as a single dose vial and available in one strength 150mg.

What HERZUMA looks like

HERZUMA is a white to pale yellow power which is dissolved in sterile water before use.

After dissolving, the HERZUMA solution should appear as a clear, colourless to yellow solution.

Ingredients

Each vial of HERZUMA contains 150 mg of the active ingredient trastuzumab.

It also contains;

  • Histidine hydrochloride
  • Histidine
  • trehalose dehydrate
  • polysorbate 20

The trastuzumab protein is made using Chinese hamster ovary cells.

Sponsor

Celltrion Healthcare Australia Pty Ltd
Suite 205, Level 2, 1 York Street
SYDNEY NSW 2000
02 9241 6341

Please check with your pharmacist for the latest Consumer Medicine Information (CMI)

HERZUMA powder for injection for intravenous infusion:

150 mg: AUST R 289146

This leaflet was prepared on August 2019.

Published by MIMS January 2020