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Enhertu 100 mg powder for concentrate for solution for infusion {equilateral_black_triangle}

Active Ingredient:
trastuzumab deruxtecan
Company:  
Daiichi Sankyo UK Limited See contact details
ATC code: 
L01FD04
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) Risk Materials HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 26 Jan 2024

{equilateral_black_triangle} This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PLGB 08265/0046.

{printer} Print patient leaflet as text only

Enhertu 100 mg powder for concentrate for solution for infusion

Package leaflet: Information for the patient

Enhertu 100 mg powder for concentrate for solution for infusion

trastuzumab deruxtecan

▼ 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. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Enhertu is and what it is used for
2. What you need to know before you are given Enhertu
3. How you are given Enhertu
4. Possible side effects
5. How to store Enhertu
6. Contents of the pack and other information

1. What Enhertu is and what it is used for
What Enhertu is

Enhertu is a cancer medicine that contains the active substance trastuzumab deruxtecan. One part of the medicine is a monoclonal antibody that attaches specifically to cells that have the protein HER2 on their surface (HER2-positive), as some cancer cells do. The other active part of Enhertu is DXd, a substance that can kill cancer cells. Once the medicine has attached to HER2-positive cancer cells, the DXd enters the cells and kills them.

What Enhertu is used for

Enhertu is used to treat adults who have:

  • HER2-positive breast cancer that has spread to other parts of the body (metastatic disease) or cannot be removed by surgery, and tried one or more other treatments specifically for HER2-positive breast cancer.
  • HER2-low breast cancer that has spread to other parts of the body (metastatic disease) or cannot be removed by surgery and received prior therapy for metastatic disease, or your disease has returned during or within 6 months of completing adjuvant chemotherapy (after surgery). A test will be performed to make sure Enhertu is right for you.
  • HER2-mutant non-small cell lung cancer that has spread to other parts of the body or cannot be removed by surgery and who have tried a prior treatment. A test will be performed to make sure Enhertu is right for you.
  • HER2-positive stomach cancer that has spread to other parts of the body or to areas near the stomach that cannot be removed by surgery and who have also tried another treatment specifically for HER2-positive stomach cancer.

2. What you need to know before you are given Enhertu
You must not be given Enhertu
  • if you are allergic to trastuzumab deruxtecan or any of the other ingredients of this medicine (listed in section 6).

If you are not sure if you are allergic, talk to your doctor or nurse before you are given Enhertu.

Warnings and precautions

Talk to your doctor or nurse before you are given Enhertu, or during treatment, 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 called interstitial lung disease. A history of lung disease or kidney problems may increase the risk of developing interstitial lung disease. Your doctor may have to monitor your lungs while you are taking this medicine.
  • chills, fever, sores in your mouth, stomach pain or pain when urinating. These may be symptoms of an infection caused by a reduced number of white blood cells called neutrophils.
  • new or worsening shortness of breath, cough, tiredness, swelling of ankles or legs, irregular heartbeat, sudden weight gain, dizziness, or loss of consciousness. These may be symptoms of a condition in which your heart cannot pump blood well enough (decreased left ventricular ejection fraction).
  • liver problems. Your doctor may have to monitor your liver while you are taking this medicine.

Your doctor will carry out tests before and during treatment with Enhertu.

Children and adolescents

Enhertu is not recommended for anyone under the age of 18 years. This is because there is no information on how well it works in this age group.

Other medicines and Enhertu

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding, contraception and fertility
  • Pregnancy
    Enhertu is not recommended during pregnancy because this medicine may harm the unborn baby.
    Speak with your doctor immediately if you are pregnant, think you may be pregnant or are planning to become pregnant before or during treatment.
  • Breast-feeding
    You should not breast-feed during treatment with Enhertu and for at least 7 months after your last dose. This is because it is not known whether Enhertu passes into breast milk. Talk to your doctor about this.
  • Contraception
    Use effective contraception (birth control) to avoid becoming pregnant while being treated with Enhertu.
    Women taking Enhertu should continue contraception for at least 7 months after the last dose of Enhertu.
    Men taking Enhertu whose partner 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. Also talk to your doctor before you stop your contraception.
  • Fertility
    If you are a man being treated with Enhertu, you should not father a child for 4 months after treatment and take advice on conserving sperm before treatment because the medicine may reduce your fertility. Therefore, discuss this with your doctor before starting treatment.

Driving and using machines

Enhertu is not likely to reduce your ability to drive or use machines. Be careful if you feel tired, dizzy, or have a headache.

3. How you are given Enhertu

Enhertu will be given to you in a hospital or clinic:

  • The recommended dose of Enhertu for the treatment of:
    • HER2-positive or HER2-low breast cancer is 5.4 mg for every kilogram of your weight, every 3 weeks.
    • HER2-mutant non-small cell lung cancer is 5.4 mg for every kilogram of your weight, every 3 weeks.
    • HER2-positive stomach cancer is 6.4 mg for every kilogram of your weight, every 3 weeks.
  • Your doctor or nurse will give you Enhertu by infusion (drip) into your vein.
  • Your first infusion will be given over 90 minutes. If this goes well, 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 get infusion-related symptoms, your doctor or nurse may slow down your infusion or interrupt or stop your treatment.
  • Before and during treatment with Enhertu, your doctor will carry out tests that may include:
    • blood tests to check your blood cells, liver and kidneys
    • testing to check your heart and lungs.
  • Your doctor may lower your dose, or temporarily or permanently stop your treatment depending on your side effects.

If you miss an appointment to get Enhertu

Contact 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 without checking with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you get any side effects, including those not listed in this leaflet.

Speak with your doctor immediately if you notice any of the following symptoms. They may be signs of a serious, possibly fatal, condition. Getting medical treatment right away may help keep these problems from becoming more serious.

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

  • A lung disease called interstitial lung disease with symptoms that can include cough, shortness of breath, fever, or other new or worsening breathing problems
  • An infection caused by reduced number of neutrophils (a type of white blood cell) with symptoms that can include chills, fever, sores in your mouth, stomach pain or pain when urinating
  • A heart problem called decreased left ventricular ejection fraction with symptoms that can include new or worsening shortness of breath, cough, tiredness, swelling of ankles or legs, irregular heartbeat, sudden weight gain, dizziness or unconsciousness

Other side effects

The frequency and severity of side effects may vary with the dose you received. Tell your doctor or nurse if you notice any of the following side effects:

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

  • nausea (feeling sick), vomiting
  • tiredness
  • decreased appetite
  • blood tests showing decreased red or white blood cells, or platelets
  • hair loss
  • diarrhoea
  • constipation
  • blood tests showing increased levels of the liver enzymes such as transaminases
  • pain in muscles and bones
  • weight loss
  • fever
  • abdominal (belly) pain
  • infections of the nose and throat, including flu-like symptoms
  • headache
  • blisters in or around your mouth
  • cough
  • blood tests showing low blood potassium levels
  • indigestion
  • infection of the lungs
  • breathing difficulties
  • nosebleed
  • swelling of ankles and feet
  • dizziness
  • altered/bad taste in mouth

Common (may affect up to 1 in 10 people)

  • rash
  • blood tests showing increased levels of bilirubin, alkaline phosphatase or creatinine
  • itching
  • dry eye
  • skin discolouration
  • blurred vision
  • feeling thirsty, dry mouth
  • bloating
  • fever along with a decreased number of white blood cells called neutrophils
  • inflammation of the stomach
  • excessive gas in the stomach or intestine
  • reactions related to the infusion of the medicine which may include fever, chills, flushing, itching or rash

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Enhertu

Enhertu will be stored by healthcare professionals at the hospital or clinic where you receive treatment. The storage details are as follows:

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the outer carton and vial after EXP. The expiry date refers to the last day of that month.
  • Store in a refrigerator (2 °C - 8 °C). Do not freeze.
  • The prepared solution for infusion is stable for up to 24 hours at 2 °C - 8 °C protected from light and must be discarded thereafter.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information
What Enhertu contains
  • The active substance is trastuzumab deruxtecan.
    One vial of powder for concentrate for solution for infusion contains 100 mg of trastuzumab deruxtecan. After reconstitution, one vial of 5 mL solution contains 20 mg/mL of trastuzumab deruxtecan.
  • The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80.

What Enhertu looks like and contents of the pack

Enhertu 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.

Marketing Authorisation Holder
Daiichi Sankyo UK Ltd
Building 4
Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen
Germany

For any information about this medicine, please contact:

Daiichi Sankyo UK Ltd.
Tel: +44 (0) 800 028 5122

This leaflet was last revised in September 2023.

This medicine has been given ‘conditional approval’. This means that there is more evidence to come about this medicine.

The MHRA will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Daiichi Sankyo UK Limited
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Address
1st Floor, Building 4, Uxbridge Business Park, Sanderson Road, Uxbridge, UB8 1DH, UK
Telephone
+44 (0) 800 028 5122
Medical Information Direct Line
+44 (0) 800 028 5122
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0) 800 028 5122
Out of Hours Telephone
+44 (0) 800 028 5122