Consumer Medicine Information (CMI) summary
The
full CMI on Page 2 has more details. If you are worried about using this medicine, speak to
your doctor or nurse.
This medicine is new or being used differently. Please report side effects. See the
full CMI (page 2) for further details.
1. Why am I using ENHERTU?
ENHERTU contains the active ingredient trastuzumab deruxtecan. ENHERTU is used to treat adults who have:
HER2-positive breast cancer that has spread to other parts of the body or cannot be
taken out by surgery and who have also received prior treatment with trastuzumab and
a taxane for metastatic disease, or have received one prior treatment for breast cancer
that has come back during or within 6 months of completing treatment for their early-stage
breast cancer.
HER2-low breast cancer that cannot be removed by surgery or that has spread to other
parts of your body (metastatic) and who have received prior chemotherapy for metastatic
disease, or your disease has returned during or within 6 months of completing adjuvant
chemotherapy (after surgery). If the breast cancer is also hormone receptor positive
(HR+), you should have received hormonal therapy. A test may be performed to make
sure ENHERTU is right for you.
For more information, see Section 1 in the
full CMI.
2. What should I know before I use ENHERTU?
Before you are given ENHERTU, tell your doctor if you have or have had any lung problems,
any kidney problems, any heart problems or any blood problems (low blood count).
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 in the
full CMI.
3. What if I am taking other medicines?
Tell your doctor or nurse if you are taking, have recently taken or might take any
other medicines. See Section 3 in the
full CMI.
4. How is ENHERTU given to me?
ENHERTU will be given to you in a hospital or clinic by a doctor or nurse. See Section
4 in the
full CMI.
5. What should I know while receiving ENHERTU?
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Things you should do
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Remind any doctor, dentist or nurse you visit that you are receiving ENHERTU.
Keep your appointments with your doctor, so that you do not miss a dose and progress
is monitored.
Use effective contraception to avoid becoming pregnant while being treated with ENHERTU.
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Things you should not do
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Do not stop using ENHERTU suddenly, unless you have discussed this with your doctor.
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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 ENHERTU
affects you.
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Call your doctor straight away
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If you experience any of the serious side effects listed in Section 6 in the full
CMI.
If you have cough, shortness of breath, fever, or other new or worsening breathing
problems.
If you become pregnant while using ENHERTU.
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Looking after your medicine
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ENHERTU will be stored by the healthcare professionals at the hospital or clinic where
you receive treatment.
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For more information, see Section 5 in the
full CMI.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, some can
be minor and temporary. However, some side effects may be serious and possibly fatal,
therefore will need immediate medical attention. See Section 6 in the
full CMI and, if you need to, ask your doctor if you have any further questions about side
effects. Tell your doctor if you experience any side effects, including those not
listed in this leaflet.
For more information, including what to do if you have any side effects, see Section
6 in the
full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.
Active ingredient: trastuzumab deruxtecan
Consumer Medicine Information (CMI)
This leaflet provides important information about using ENHERTU. You should also speak to your doctor or nurse if you would like further information
or if you have any concerns or questions about using ENHERTU.
Where to find information in this leaflet:
1. Why am I using ENHERTU?
ENHERTU contains the active ingredient trastuzumab deruxtecan. ENHERTU is made up of a monoclonal antibody connected to a medicine intended to kill
cancer cells. The monoclonal antibody delivers the medicine to cancer cells that express
HER2 proteins. Once ENHERTU enters the cell, the medicine becomes active and kills
the cancer cells.
ENHERTU is used to treat adults who have:
HER2-positive breast cancer that has spread to other parts of the body or cannot be
taken out by surgery and who have also received prior treatment with trastuzumab and
a taxane for metastatic disease, or have received one prior treatment for breast cancer
that has come back during or within 6 months of completing treatment for their early-stage
breast cancer.
HER2-low breast cancer that cannot be removed by surgery or that has spread to other
parts of your body (metastatic) and who have received prior chemotherapy for metastatic
disease, or your disease has returned during or within 6 months of completing adjuvant
chemotherapy (after surgery). If the breast cancer is also hormone receptor positive
(HR+), you should have received hormonal therapy. A test may be performed to make
sure ENHERTU is right for you.
2. What should I know before I use ENHERTU?
Warnings and precautions
Check with your doctor if you:
have or have had any lung problems, any kidney problems, any heart problems or any
blood problems (low blood count).
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Pregnancy
ENHERTU is not recommended if you are pregnant because this medicine may cause harm
to the unborn baby.
Tell your doctor before using ENHERTU if you are pregnant, think you may be pregnant
or are planning to have a baby.
Use effective contraception to avoid becoming pregnant while you are being treated
with ENHERTU. Talk to your doctor about the best contraception for you.
Females should continue to take contraception for at least 7 months after your last
dose of ENHERTU. Talk to your doctor before stopping your contraception.
Male patients with a female partner who could become pregnant should use effective
contraception during treatment and for at least 4 months after the last dose of ENHERTU.
If you do become pregnant during treatment with ENHERTU, tell your doctor right away.
Breastfeeding
You should not breastfeed during treatment with ENHERTU.
You should not breastfeed for at least 7 months after your last treatment of ENHERTU.
It is not known whether the ingredients in ENHERTU pass into breast milk. Talk to
your doctor about this.
Fertility
Talk to your doctor about sperm storage before treatment with ENHERTU because the
medicine may reduce your fertility. Do not freeze or donate sperm throughout the treatment
period, and for at least 4 months after the final dose of ENHERTU.
Children and adolescents
ENHERTU is not recommended for anyone under the age of 18 years.
3. What if I am taking other medicines?
Tell your doctor 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.
Check with your doctor if you are not sure about what medicines, vitamins or supplements
you are taking and if these affect ENHERTU.
4. How is ENHERTU given to me?
How you are given ENHERTU
ENHERTU will be given to you in a hospital or clinic.
The recommended dose of ENHERTU is 5.4 mg for every kilogram of your body weight,
every 3 weeks.
Your doctor or nurse will give you ENHERTU through an infusion into your vein (IV).
Your first infusion will be given to you over 90 minutes. If you have no problems
with the first infusion, the infusion on your next visits may be given over 30 minutes.
Your doctor will decide how many treatments you need.
Before each ENHERTU infusion, your doctor may give you medicines to help prevent nausea
and vomiting.
If you experience infusion-related symptoms, your doctor or nurse may slow, interrupt
or stop your treatment.
If you miss an appointment to get ENHERTU
Call your doctor right away to reschedule your appointment.
It is very important that you do not miss a dose of this medicine.
If you stop receiving ENHERTU
Do not stop treatment with ENHERTU unless you have discussed this with your doctor.
If you have any further questions about your treatment, ask your doctor.
5. What should I know while receiving ENHERTU?
Things you should do
Remind any doctor, dentist or nurse you visit that you are receiving ENHERTU.
Keep your appointments with your doctor, so that you do not miss a dose and progress
is monitored.
Tell your doctor or nurse if you are taking other medicines, vitamins or supplements.
Tell your doctor if you experience any side effects, including those not listed in
this leaflet.
Use effective contraception to avoid becoming pregnant while being treated with ENHERTU
(see
Contraception below).
Call your doctor straight away if you:
have cough, shortness of breath, fever, or other new or worsening breathing problems.
These may be symptoms of a serious and potentially fatal lung disease (interstitial
lung disease [ILD] and/or pneumonitis). Patients with a history of this lung disease
or kidney problems may have increased risk of developing interstitial lung disease.
Your doctor may have to monitor your lungs while you are taking this medicine.
have chills, fever, sores in your mouth, stomach pain or pain when urinating. These
may be symptoms of an infection caused by low levels of a type of white blood cell
called neutrophils (neutropenia).
have new or worsening shortness of breath, cough, tiredness, swelling of your ankles
or legs, irregular heartbeat, sudden weight gain, dizziness, or loss of consciousness.
These may be symptoms of a problem with your heart’s ability to pump blood (left ventricular
ejection fraction [LVEF] decrease).
become pregnant while using ENHERTU.
Things you should not do
Do not stop using ENHERTU suddenly, unless you have discussed this with your doctor.
Contraception
Use effective contraception to avoid becoming pregnant while being treated with ENHERTU.
Females should continue to take contraception for at least 7 months after your last
dose of ENHERTU.
Men with a female partner who may become pregnant should use effective contraception:
during treatment and
for at least 4 months after the last dose of ENHERTU.
Talk to your doctor about the best contraception for you or before stopping your contraception.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how ENHERTU
affects you.
It is not expected that ENHERTU affects your ability to drive or use machines. Be
careful if you feel tired, dizzy, or have a headache.
Looking after your medicine
ENHERTU will be stored by the healthcare professionals at the hospital or clinic where
you receive treatment.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, some can
be minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor if you have any further
questions about side effects.
Tell your doctor if you experience any side effects, including those not listed in
this leaflet.
While you are taking ENHERTU
Your doctor will carry out tests before and during your treatment with ENHERTU
Depending on the side effects you experience, your doctor may decide to lower your
dose, temporarily stop your treatment or permanently stop your treatment.
Serious side effects
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Serious side effects
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What to do
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cough, shortness of breath (dyspnoea), fever, or other new or worsening breathing
problems as these may be symptoms of a lung problem (interstitial lung disease/pneumonitis).
chills, fever, sores in your mouth, stomach pain or pain when urinating as these may
be symptoms of an infection caused by low levels of a type of white blood cell called
neutrophils (neutropenia).
new onset or worsening shortness of breath, cough, tiredness, swelling of your ankles
or legs, irregular heartbeat, sudden weight gain, dizziness, or loss of consciousness
as these may be symptoms of a problem with your heart’s ability to pump blood (left
ventricular ejection fraction [LVEF] decrease).
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these symptoms because some of them may be signs
of a serious or possibly fatal condition. See Section
5
(
What should I know while receiving ENHERTU?
). Getting medical treatment right away may help keep these problems from becoming
more serious.
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You may experience the following side effects:
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Very common (may affect more than 1 in 10 people)
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What to do
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Nausea
Feeling tired (fatigue)
Vomiting
Hair loss (alopecia)
Constipation
Feeling less hungry
Diarrhoea
Coughing
Stomach (abdominal) pain
Headache
Fever (pyrexia)
Infections of the nose, nasal passages, throat, voice box and vocal cords
Sores in or around your mouth (stomatitis)
Difficulty breathing (dyspnoea)
Indigestion (dyspepsia)
Severe nosebleeds (epistaxis)
Lung problems (interstitial lung disease/pneumonitis)
Rash
Dizziness
Pain in muscles and bone
Weight loss
Decrease in the number of red blood cells (anaemia)
Decrease in the number of neutrophils (neutropenia)
Decrease in the number of platelets (thrombocytopenia)
Decrease in the number of white blood cells (leukopenia)
Decrease in the number of lymphocytes (lymphopenia)
Blood tests showing increased level of liver enzymes such as transaminases (aspartate
aminotransferase, alanine aminotransferase, gamma-glutamyltransferase). These are
liver function tests that indicate abnormality.
Low potassium in the blood (hypokalaemia)
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Speak to your doctor if you have any of these very common side effects and they worry
you.
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Common (may affect up to 1 in 10 people)
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What to do
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Reactions related to the infusion of the medicine
Itching (pruritus)
Darkening of the skin (skin hyperpigmentation)
Bad taste in mouth (dysgeusia)
Excessive gas in the stomach or intestine, bloating and breaking wind (abdominal distension
and flatulence)
Inflammation of the stomach (gastritis)
Feeling thirsty, dry mouth (dehydration)
Blurry vision
Dry eye
Abnormal blood test (increased levels of blood bilirubin, blood creatinine or blood
alkaline phosphatase)
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Speak to your doctor if you have any of these common side effects and they worry you.
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Tell your doctor if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
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 before you decide to stop taking any of
your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ENHERTU contains
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Active ingredient
(main ingredient)
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Trastuzumab deruxtecan
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Other ingredients
(inactive ingredients)
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Histidine, histidine hydrochloride monohydrate, sucrose, and polysorbate 80
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What ENHERTU looks like
ENHERTU (Aust R 343262) is a white to yellowish-white lyophilised powder supplied
in a clear amber vial with a rubber stopper, aluminium seal and plastic flip-off cap.
Each carton contains 1 vial.
Who distributes ENHERTU
AstraZeneca Pty Ltd
ABN 54 009 682 311
66 Talavera Road
MACQUARIE PARK NSW 2113
Telephone: 1800 805 342
This leaflet was prepared in May 2024
ENHERTU® is a trademark of the Daiichi Sankyo Company limited, used under license by AstraZeneca.
© AstraZeneca, 2024
VV-RIM-01450360 v7.0