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Perjeta

Contains the active ingredient pertuzumab (rch)
Consumer Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Perjeta. It does not contain all the information that is known about Perjeta. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What PERJETA is given for

PERJETA contains an active ingredient called pertuzumab.
PERJETA belongs to a group of medicines known as anti-neoplastic (or anti-cancer) agents. There are many different classes of anti-neoplastic agents. PERJETA 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.
PERJETA recognises and attaches 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 PERJETA attaches to HER2 cancer cells it may kill them or slow/stop the cancer cells from growing.
PERJETA is used to treat the following stages of breast cancer;
metastatic (spreading) breast
cancer
inflammatory or locally advanced breast cancer before surgery
It is only used for patients whose tumour has tested positive to HER2.
PERJETA is used with HERCEPTIN and the chemotherapy medicine, docetaxel. When PERJETA is used before surgery it is also used with or following other chemotherapy medicines. While HERCEPTIN treatment is continued after your surgery, PERJETA is not continued after your operation.
For further information about HERCEPTIN and other chemotherapy medicines please ask your doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) leaflets for these medicines.
Ask your doctor if you have any questions why PERJETA has been prescribed for you.
This medicine is available only with a doctor's prescription.

Before you are given PERJETA

If you are not sure if you should start receiving PERJETA, talk to your doctor.

Before you are given it

Tell your doctor if:
you have a history of heart problems such as;
heart failure (where the heart muscle cannot pump blood strongly enough)
cardiac arrhythmias (abnormal beating of the heart)
poorly controlled high blood pressure or
recent heart attack
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 PERJETA
you have ever had heart
problems during previous treatment with HERCEPTIN
Your doctor will monitor your heart function closely before, and during your treatment with PERJETA.
you have inflammation of the digestive tract, for e.g. sore mouth or diarrhoea
When PERJETA is given with other cancer treatments the number of white blood cells may drop and fever may develop. If you have inflammation of the digestive tract (e.g sore mouth or diarrhoea) you may be more likely to develop this side effect
you are allergic to any other medicines or any other substances such as foods, preservatives or dyes
Allergic or anaphylactic (more severe allergic) reactions can occur with PERJETA treatment (known as infusion related reactions). Your doctor or nurse will check for side effects during your infusion and for 30 - 60 minutes afterwards. If you get any serious reactions, your doctor may stop treatment with PERJETA. See "Side effects" for symptoms to look out for.
you are pregnant or intend to become pregnant
Do not use PERJETA if you are pregnant. PERJETA may be harmful to your unborn baby.
Your doctor will advise you about using effective contraception to avoid becoming pregnant while you are being treated with PERJETA and for 6 months after stopping treatment.
you are breast-feeding or plan to breast-feed
It is not known if PERJETA passes into breast milk. You should talk to your doctor about whether you can breast feed while you are being treated with PERJETA.
If you have not told your doctor about any of the above, tell them before you are given PERJETA.

Use in children

The safety and effectiveness of PERJETA in children and adolescents 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.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while receiving PERJETA.

How PERJETA is given

Follow all directions given to you by your doctor or nurse carefully.
They may differ from the information contained in this leaflet.
PERJETA must be prepared by a healthcare professional and will be given in a hospital or clinic by a doctor or nurse.
PERJETA is given by a drip into a vein (intravenous (IV) infusion) once every three weeks.
The amount of medicine you are given, and how long the infusion will last, are different for the first and following doses.
The number of infusions you will be given depends on how you respond to treatment.
PERJETA is given with other anti-cancer medicines.
The first infusion:
you will be given 840 mg (two vials) of PERJETA by IV drip over 60 minutes. You will also be given HERCEPTIN and docetaxel.
For following infusions:
if the first infusion was well tolerated, you will be given 420 mg (one vial) of PERJETA by IV drip over 30 - 60 minutes. You will also be given HERCEPTIN and docetaxel.
For further information about the dose of other anti-cancer medicines given, please ask your doctor, nurse or pharmacist for the Consumer Medicine Information (CMI) leaflets for these medicines.

If you miss a dose

As PERJETA 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 PERJETA, make another appointment as soon as possible.
If it has been 6 weeks or more since your last PERJETA treatment, the high dose of PERJETA (840 mg) will be given. You will also be given HERCEPTIN and docetaxel.
Your doctor will decide when and how much your next dose of PERJETA will be.

If you are given too much (overdose)

As PERJETA is given 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 PERJETA, tell your doctor immediately.

While you are receiving PERJETA

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 PERJETA.
Tell your doctor if you become pregnant or intend to start a family while receiving PERJETA or within 6 months after your last PERJETA treatment.
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 PERJETA treatment without talking to your doctor first.
Tell your doctor if you feel that PERJETA 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 PERJETA affects you.
It is not known whether PERJETA may impair 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 PERJETA.
PERJETA 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 PERJETA may be used with other medicines that treat breast cancer, it may be difficult for your doctor to tell whether the side effects are due to PERJETA or due to the other medicines.
For further information about the side effects of HERCEPTIN and docetaxel, 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)
diarrhoea
fever or chills
headache
fatigue or tiredness
cough
These may be serious side effects. You may need medical attention.

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 swelling of your hands or feet
severe shortness of breath, wheezing or trouble breathing
severe chest pain, spreading out to the arms, neck, shoulder or back
abnormal or irregular heartbeat
rash, itching or hives on the skin
fever or chills
severe coughing
Tell your doctor or nurse as soon as possible if you notice any of the following:
any of the side effects listed above
diarrhoea or constipation
sore mouth, throat or gut
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
nail problems especially inflammation where the nail meets the skin
hair loss
feeling dizzy, tired, looking pale
frequent infections such as fever, severe chills, sore throat or mouth ulcers
eye problems such as producing more tears
insomnia (trouble sleeping)
weak, numb, tingling or prickling sensations mainly affecting the feet and legs
loss of appetite, loss of or altered taste
joint or muscle pain, muscle weakness
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, nurse 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

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

Availability

PERJETA is supplied as a single-dose glass vial containing 14 mL of solution for intravenous infusion (30 mg/mL). It is diluted before infusion into a vein.

What PERJETA looks like

PERJETA is a clear to pearly (opalescent), colourless to slightly brownish solution.

Ingredients

Each vial of PERJETA contains 420 mg of the active ingredient pertuzumab
It also contains:
glacial acetic acid
histidine
sucrose
polysorbate 20
The pertuzumab protein is made using chinese hamster ovary cells.

Distributor

PERJETA 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
Distributed in New Zealand by:
Roche Products (New Zealand) Limited
PO Box 109113 Newmarket
Auckland 1149
NEW ZEALAND
Customer enquiries: 0800 656 464
Please check with your pharmacist for the latest Consumer Medicine Information (CMI).
Australian Registration Number:
AUST R 196218
This leaflet was prepared on 12 May 2016