Enhertu

trastuzumab deruxtecan


ENHERTU®


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 in adults who have:

  • HER2-positive breast cancer that has spread to other parts of the body or cannot be taken out by surgery and
  • have also received two or more prior treatments that targeted HER2-positive breast cancer.

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 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.

More instructions can be found in Section 4 in the full CMI.

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.
  • Use effective contraception to avoid becoming pregnant while being treated with ENHERTU (see Section 5 in the full CMI).

Things you should not do

  • Do not stop using ENHERTU suddenly, unless you have discussed this with your doctor.

Driving or using machines

  • Be careful before you drive or use any machines or tools until you know how ENHERTU affects you.

Call your doctor straight away

  • If you experience any of the serious side effects listed in Section 6 in the full CMI.
  • If you become pregnant while using ENHERTU.

Looking after your medicine

  • ENHERTU will be stored by the healthcare professionals at the hospital or clinic where you receive treatment.

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.

ENHERTU®

Active ingredient: trastuzumab deruxtecan

This medicine has provisional registration in Australia for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. The decision to provisionally register this medicine has been made on the basis of promising results from preliminary studies. More evidence is required to be submitted when available to substantiate the benefit of the medicine for this use.


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 (known as HER2-positive). Once ENHERTU enters the cell, the medicine becomes active and kills the cancer cells.

ENHERTU is used in adults who have:
  • HER2-positive breast cancer that has spread to other parts of the body or cannot be taken out by surgery and
  • have also received two or more prior treatments that targeted HER2-positive breast cancer.

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 heart problems or any blood problems (low blood count).

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 5 (What should I know while receiving ENHERTU?) and Section 6 (Are there any side effects?).

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.
  • 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).
  • 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.
  • experience any of the serious side effects listed in Section 6 (Are there any side effects?).

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

Serious side effects

What to do

  • 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).

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.

You may experience the following side effects:

Very common (may affect more than 1 in 10 people)

What to do

  • Nausea
  • Feeling tired (fatigue)
  • Vomiting
  • Hair loss (alopecia)
  • Constipation
  • Feeling less hungry
  • Diarrhoea
  • Coughing
  • Stomach (abdominal) pain
  • Headache
  • 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
  • Dry eye
  • Dizziness
  • 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)
  • Abnormal liver enzyme results (increase in aspartate aminotransferase)
  • Abnormal liver enzyme results (increase in alanine aminotransferase)
  • Low potassium in the blood (hypokalaemia)

Speak to your doctor if you have any of these very common side effects and they worry you.

Common (may affect up to 1 in 10 people)

What to do

  • Reactions related to the infusion of the medicine
  • Fever along with a decrease in the number of neutrophils (febrile neutropenia)

Speak to your doctor if you have any of these common side effects and they worry you.

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

Active ingredient
(main ingredient)

Trastuzumab deruxtecan

Other ingredients
(inactive ingredients)

Histidine, histidine hydrochloride monohydrate, sucrose, and polysorbate 80

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 October 2021.

ENHERTU® is a trademark of the Daiichi Sankyo Company limited, used under license by AstraZeneca.

© AstraZeneca, 2021

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