Herceptin (trastuzumab) Drug / Medicine Information

Contains the active ingredient trastuzumab (rch)

Consumer Medicine Information

What HERCEPTIN is given for

HERCEPTIN contains an active ingredient called trastuzumab.

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

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

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

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

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

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

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

Before you are given HERCEPTIN

When you must not be given it

Do not use HERCEPTIN if:

you have had an allergic reaction to;

HERCEPTIN,

any ingredient 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 HERCEPTIN, 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 HERCEPTIN

Your doctor will monitor your heart function closely before and during your treatment with HERCEPTIN.

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 HERCEPTIN treatment (known as infusion related reactions). Your doctor or nurse will check for side effects during your infusion. See "side effects" for symptoms to look out for.

you are pregnant or intend to become pregnant

HERCEPTIN may be harmful to an unborn baby. If there is a need for HERCEPTIN 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 HERCEPTIN and for 6 months after stopping treatment.

you are breast-feeding or plan to breast-feed

It is not known if HERCEPTIN passes into breast milk. It is recommended that you discontinue breast-feeding while you are being treated with HERCEPTIN and not restart breast-feeding until 6 months after completing HERCEPTIN treatment.

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

Use in children

The safety and effectiveness of HERCEPTIN 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.

HERCEPTIN 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 HERCEPTIN.

Tell your doctor or pharmacist that you have had HERCEPTIN if you start any new medication in the six months after stopping treatment.

It may take up to six months for HERCEPTIN to be removed from your body

How HERCEPTIN is given

Follow all directions given to you by your doctor or nurse carefully.

They may differ from the information contained in this leaflet.

HERCEPTIN must be prepared by a healthcare professional and will be given in a hospital or clinic by a doctor or nurse.

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

The first HERCEPTIN infusion is given over 90 minutes. If the first infusion is well tolerated, your drip time may be shortened to 30 minutes.

Your doctor will decide the HERCEPTIN dose and treatment regimen that is right for your condition.

For the treatment of breast cancer, HERCEPTIN 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 HERCEPTIN is given every three weeks in combination with other medicines used to treat gastric cancer.

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

If you miss a dose

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

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

If you are given too much (overdose)

As HERCEPTIN 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 HERCEPTIN, tell your doctor immediately.

While you are receiving HERCEPTIN

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 HERCEPTIN.

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

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 HERCEPTIN treatment without talking to your doctor first.

Tell your doctor if you feel that HERCEPTIN 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 HERCEPTIN affects you.

HERCEPTIN does not generally cause any problems with your ability to drive or operate machinery.

Side effects

Tell your doctor as soon as possible if you do not feel well while you are receiving HERCEPTIN.

HERCEPTIN 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 HERCEPTIN 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 HERCEPTIN 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 while receiving your HERCEPTIN infusion.

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)

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

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

Availability

HERCEPTIN is supplied as a single dose vial and is available in two strengths, 60 mg and 150 mg.

What HERCEPTIN looks like

HERCEPTIN is a white to pale yellow powder which is dissolved in sterile water before use.

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

Ingredients

Each vial of HERCEPTIN contains 60 mg or 150 mg of the active ingredient trastuzumab.

It also contains;

histidine hydrochloride

histidine

trehalose dihydrate

polysorbate 20

The trastuzumab protein is made using chinese hamster ovary cells.

Distributor

HERCEPTIN is distributed by:

Roche Products Pty Limited

ABN 70 000 132 865

4-10 Inman Road

Dee Why NSW 2099

AUSTRALIA

Customer enquiries: 1800 233 950

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

Australian Registration Numbers:

60 mg: AUST R 171014

150 mg: AUST R 73229

This leaflet was prepared on 5 December 2012