Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using Kadcyla?
Kadcyla contains the active ingredient trastuzumab emtansine (rch). Kadcyla is used
to treat early HER2-positive breast cancer following surgery and advanced or metastatic
HER2-positive breast cancer, i.e. the cancer has spread to areas near the breast or
to other parts of your body. For more information, see Section
1. Why am I using Kadcyla? in the full CMI.
2. What should I know before I use Kadcyla?
Do not use if you have ever had an allergic reaction to trastuzumab emtansine or any
of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section
2. What should I know before I use Kadcyla? in the full CMI.
3. What if I am taking other medicines?
4. How is Kadcyla given?
Kadcyla is given by a slow drip into a vein (intravenous (IV) infusion) by a doctor
or nurse once every three weeks. The first infusion will be over 90 minutes. If the
first infusion is well tolerated, your drip time may be shortened to 30 minutes. More
instructions can be found in Section
4. How is Kadcyla given? in the full CMI.
5. What should I know while using Kadcyla?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are receiving Kadcyla.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
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Things you should not do
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Do not stop using this medicine without speaking to your doctor first.
Do not take any other medicines, whether they require a prescription or not, without
first telling your doctor or consulting with a pharmacist.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how Kadcyla
affects you.
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6. Are there any side effects?
There are a number of side effects associated with Kadcyla. It is important to be
aware of them so that you can identify any symptoms if they occur (see the full CMI
for more details). Tell your doctor or nurse immediately or go to the nearest hospital
Emergency Department if you experience signs or symptoms of a serious allergic reaction
such as fever or chills, swelling of the face, lips, tongue, throat or other parts
of the body, dizziness or fainting, trouble breathing or wheezing, coughing, rash,
itching or hives on the skin.
Some other serious side effects of Kadcyla include burning sensation or tenderness
at the site of injection, nausea, vomiting, diarrhoea, pain or discomfort, fatigue,
bleeding or bruising, dark urine or yellowing of your skin and eyes.
Tell your doctor or nurse immediately or go to the Emergency Department if you experience
any of these side effects. For more information, including what to do if you have
any side effects, see Section
6. Are there any side effects? in the full CMI.
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WARNING: Do not substitute Kadcyla for or with trastuzumab.
In order to prevent medication errors, check the vial labels to ensure the medicine
being prepared and administered is Kadcyla (trastuzumab emtansine) and not trastuzumab.
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Active ingredient(s):
trastuzumab emtansine
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Kadcyla. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Kadcyla.
Where to find information in this leaflet:
1. Why am I using Kadcyla?
Kadcyla contains the active ingredient trastuzumab emtansine. Kadcyla belongs to a group of medicines known as anti-neoplastic (or anti-cancer)
agents.
Kadcyla is made up of two substances:
trastuzumab - a monoclonal antibody which 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. Monoclonal antibodies are proteins made in a laboratory.
These proteins are designed to recognise and bind to other unique proteins in the
body.
emtansine - an anti-cancer substance.
Kadcyla is designed to target and deliver the anti-cancer emtansine directly inside
HER2-positive cancer cells to stop the growth and spread of the cancer cells.
Kadcyla is used to treat the following stages of HER2-positive breast cancer:
early breast cancer following surgery.
advanced or metastatic breast cancer, i.e the cancer has spread to areas near the
breast or to other parts of your body.
It is only used in patients whose tumour has tested positive to HER2. You may have
previously received HER2 targeted therapies.
2. What should I know before I use Kadcyla?
Warnings
Do not use Kadcyla if:
you are allergic to trastuzumab emtansine, or any of the ingredients listed at the
end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
you have had a serious infusion-related reaction to trastuzumab
you have a history of heart problems.
Your doctor will monitor your heart function closely before and during your treatment
with Kadcyla.
you have any breathing or lung problems
you have liver problems
you have bleeding problems
you are receiving anti-coagulant treatment (blood thinning medications) e.g. warfarin,
heparin or low molecular weight heparin
Kadcyla can lower the number of platelets in your blood. Platelets help your blood
to clot so you might get unexpected bleeding (such as nose bleeds, bleeding from gums).
Your doctor or nurse will monitor your platelet levels during your treatment with
Kadcyla.
take any medicines for any other condition
you are allergic to any other medicines or any other substances such as foods, preservatives
or dyes
Allergic and/or anaphylactic reactions can occur with Kadcyla treatment (known as
infusion related reactions). Your doctor or nurse will check for side effects during
your infusion. See Section
6. Are there any side effects? for symptoms to look out for.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Do not use Kadcyla if you are pregnant. Kadcyla may be harmful to your unborn baby.
Your doctor will advise you about using effective contraception to avoid you or your
partner becoming pregnant while you are being treated with Kadcyla and for at least
7 months after stopping treatment. It is not known if Kadcyla affects the ability
of a woman to become pregnant. Discuss any future child bearing plans with your doctor
before starting Kadcyla.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
It is not known if Kadcyla passes into breast milk. It is recommended that you discontinue
breast-feeding while you are being treated with Kadcyla and not start breast-feeding
until 7 months after completing Kadcyla treatment.
If you have not told your doctor about any of the above, tell them before you are
given Kadcyla
Use in children
The safety and effectiveness of Kadcyla in children under 18 years of age have not
been established.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Kadcyla and affect how it works.
Oral antifungal medications, e.g. ketoconazole, itraconazole, voriconazole
Some antibiotics used to treat bacterial infections, e.g. clarithromycin
Some medicines used to treat hepatitis
Medicines used to treat depression
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while receiving Kadcyla.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Kadcyla.
4. How is Kadcyla given?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
Kadcyla is prepared by a healthcare professional and will be given in a hospital or
clinic by a doctor or nurse.
Kadcyla is given by a slow drip into a vein (intravenous (IV) infusion) once every
three weeks.
The first infusion will be given over 90 minutes. If the first infusion is well tolerated,
your drip time may be shortened to 30 minutes.
You doctor will decide how long you should receive Kadcyla. This will depend on how
you respond to treatment and the state of your disease.
If you miss a dose of Kadcyla
As Kadcyla 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 Kadcyla, make another
appointment as soon as possible. Do not wait for your next planned appointment. Your
doctor will decide when your next dose of Kadcyla will be.
If you are given too much Kadcyla (overdose)
As Kadcyla 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 Kadcyla,
tell your doctor or nurse immediately.
5. What should I know while using Kadcyla?
Things you should do
Tell all doctors, dentists and pharmacists who are treating you that you are receiving
Kadcyla.
Tell your doctor if you intend to start a family while receiving Kadcyla.
Tell your doctor if you feel that Kadcyla is not helping your condition.
Be sure to keep all of your appointments with your doctor so that your progress can
be checked.
Your doctor will perform regular tests to monitor for;
Liver problems
Heart problems
Bleeding problems
Lung problems
Call your doctor straight away if you:
become pregnant
Remind any doctor, dentist, pharmacist or nurse you visit that you are using Kadcyla.
Things you should not do
Do not stop your Kadcyla treatment without talking to your doctor first.
Do not take any other medicines, whether they require a prescription or not, without
first telling your doctor or consulting with a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Kadcyla
affects you.
It is not known whether Kadcyla may affect your ability to drive or operate machinery.
If you experience infusion-related reactions, such as flushing, shivering episodes,
fever, trouble breathing, low blood pressure or a rapid heartbeat, do not drive and
use machines until symptoms abate.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Kadcyla will be stored in the pharmacy or on the hospital ward in a refrigerator at
a temperature between 2°C and 8°C. Kadcyla solution should not be frozen.
6. Are there any side effects?
Tell your doctor as soon as possible if you do not feel well while you are receiving
Kadcyla.
Kadcyla may have some unwanted side effects in some people.
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may be more serious and need
medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
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.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Kadcyla contains
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Active ingredient
(main ingredient)
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Each vial of Kadcyla contains 100 mg or 160 mg of the active ingredient, trastuzumab
emtansine.
The trastuzumab protein is made using Chinese hamster ovary cells.
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Other ingredients
(inactive ingredients)
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Succinic acid
Sodium hydroxide
Sucrose
Polysorbate 20
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Do not take this medicine if you are allergic to any of these ingredients.
What Kadcyla looks like
Kadcyla is a white to off-white powder which is dissolved in sterile water before
use.
After dissolving, the Kadcyla solution should appear as a clear colourless to pale
brown solution.
Kadcyla is supplied as a single use vial and is available in two strengths, 100 mg
and 160 mg.
100 mg: AUST R 201621
160 mg: AUST R 201622
Who distributes Kadcyla
Roche Products Pty Limited
ABN 70 000 132 865
Level 8, 30-34 Hickson Road
Sydney NSW 2000
AUSTRALIA
Medical enquiries: 1800 233 950
This leaflet was prepared in April 2022.