KANJINTI®
Intravenous infusion
Contains the active ingredient trastuzumab (rch)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about KANJINTI. 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 KANJINTI 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 KANJINTI is given for
KANJINTI contains an active ingredient called trastuzumab.
KANJINTI is a biosimilar medicine. A biosimilar medicine is a highly similar version
of an original brand of a biological medicine, marketed by a different manufacturer
once the patent on the original brand expires. Biosimilar brands of biological medicines
are thoroughly tested to show that they are just as safe and effective as the original
brand.
KANJINTI belongs to a group of medicines known as anti-neoplastic (or anti-cancer)
agents. There are many different classes of anti-neoplastic agents. KANJINTI 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.
KANJINTI 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
KANJINTI binds to HER2 it stops the growth and spread of the cancer cells.
KANJINTI is used to treat breast and gastric cancer. It is only used in patients whose
tumour has tested positive to HER2.
KANJINTI 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, KANJINTI is used with chemotherapy medicines
cisplatin and capecitabine (or 5FU).
For further information about the other medicines you are receiving with KANJINTI,
please ask your doctor, nurse or pharmacist for the Consumer Medicine Information
(CMI) leaflet.
Ask your doctor if you have any questions why KANJINTI has been prescribed for you.
This medicine is available only with a doctor's prescription.
When you must not be given it
Do not use KANJINTI if:
you have had an allergic reaction to;
KANJINTI,
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 KANJINTI, 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 KANJINTI
Your doctor will monitor your heart function closely before and during your treatment
with KANJINTI. Your heart function may also be monitored for years after ceasing KANJINTI
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 KANJINTI 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
KANJINTI may be harmful to an unborn baby. If there is a need for KANJINTI 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 KANJINTI, and for 7 months after stopping treatment.
you are breast-feeding or plan to breast-feed
It is not known if KANJINTI passes into breast milk. It is recommended that you discontinue
breast-feeding while you are being treated with KANJINTI and not restart breast-feeding
until 7 months after completing KANJINTI treatment
If you have not told your doctor about any of the above, tell them before you are
given KANJINTI.
Use in children
The safety and effectiveness of KANJINTI 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.
KANJINTI 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 KANJINTI.
Tell your doctor or pharmacist that you have had KANJINTI if you start any new medication
in the seven months after stopping treatment.
It may take up to seven months for KANJINTI to be removed from your body
How KANJINTI is given
Follow all directions given to you by your doctor or nurse carefully.
They may differ from the information contained in this leaflet.
KANJINTI must be prepared by a healthcare professional and will be given in a hospital
or clinic by a doctor or nurse.
KANJINTI is given by "drip" into a vein (intravenous (IV) infusion).
The first KANJINTI 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, KANJINTI 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, KANJINTI is given every three weeks in combination
with other medicines used to treat gastric cancer.
Your doctor will decide how long you should receive KANJINTI, this will depend on
your response to the medicine and the state of your disease.
If you miss a dose
As KANJINTI 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 KANJINTI, make
another appointment as soon as possible.
Your doctor will decide when and how much your next dose of KANJINTI will be.
If you are given too much (overdose)
As KANJINTI 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 KANJINTI, tell your doctor immediately.
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
KANJINTI.
Tell your doctor if you become pregnant or intend to start a family while receiving
KANJINTI.
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 KANJINTI treatment without talking to your doctor first.
Tell your doctor if you feel that KANJINTI 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 KANJINTI affects you.
If you experienced symptoms during your treatment with KANJINTI you should not drive
or operate machinery.
Side effects
Tell your doctor as soon as possible if you do not feel well while you are receiving
KANJINTI.
KANJINTI 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 KANJINTI 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 KANJINTI
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)
confusion
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)
decrease or loss of appetite
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.
Storage
KANJINTI will be stored in the pharmacy or on the hospital ward in a refrigerator
at a temperature between 2°C and 8°C.
Availability
KANJINTI is available as a powder for intravenous infusion (drip into the vein). Supplied
as a single dose vial and available in two strengths, 150 mg and 420 mg.
It is important to check the product labels to ensure that the correct formulation
is being given as prescribed.
What KANJINTI looks like
KANJINTI is a white to pale yellow powder which is dissolved in sterile water before
use.
After dissolving, the KANJINTI solution should appear as a clear colourless to yellow
solution.
Ingredients
Each vial of KANJINTI contains 150 mg or 420 mg of the active ingredient trastuzumab.
It also contains;
histidine hydrochloride monohydrate
histidine
trehalose dihydrate
polysorbate 20
The trastuzumab protein is made using chinese hamster ovary cells.
Distributor
KANJINTI is distributed by:
Amgen Australia Pty Ltd
Level 11, 10 Carrington St
Sydney NSW 2000
Ph: 1800 803 638
www.amgenmedinfo.com.au
Please check with your pharmacist for the latest Consumer Medicine Information (CMI)
Australian Registration Numbers:
KANJINTI powder for intravenous infusion:
150 mg: AUST R 296881
420 mg: AUST R 296883
This leaflet was prepared in February 2022
