Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - enhertu

Document Subject

Generated Narrative: MedicinalProductDefinition mp5b51c0d839da71000ee4c963dc89729f

identifier: http://ema.europa.eu/identifier/EU/1/20/1508/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Enhertu 100 mg powder for concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-5b51c0d839da71000ee4c963dc89729f

identifier: http://ema.europa.eu/identifier/EU/1/20/1508/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - enhertu

Attesters

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

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.

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.

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.

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 nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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.

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 Europe GmbH Zielstattstrasse 81379 Munich Germany

Manufacturer Daiichi Sankyo Europe GmbH Luitpoldstrasse 1 85276 Pfaffenhofen Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Daiichi Sankyo Belgium N.V.-S.A T l/Tel: +32-(0) 2 227 18 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660

.: +359 24455Luxembourg/Luxemburg Daiichi Sankyo Belgium N.V.-S.A T l/Tel: +32-(0) 2 227 18 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark Daiichi Sankyo Nordics ApS Tlf: +45 (0) 33 68 19 Malta Daiichi Sankyo Europe GmbH Tel: +49-(0) 89 7808 0

Deutschland Daiichi Sankyo Deutschland GmbH Tel: +49-(0) 89 7808 0

Nederland Daiichi Sankyo Nederland B.V. Tel: +31-(0) 20 4 07 20 Eesti AstraZeneca Tel: +372 6549 Norge Daiichi Sankyo Nordics ApS Tlf: +47 (0) 21 09 38
AstraZeneca A.E. : +30 210 6871 sterreich Daiichi Sankyo Austria GmbH Tel: +43 (0) 1 485 86 42 0

Espa a Daiichi Sankyo Espa a, S.A. Tel: +34 91 539 99 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel: +48 22 245 73 France Daiichi Sankyo France S.A.S. T l: +33 (0) 1 55 62 14 Portugal Daiichi Sankyo Portugal, Unip. LDA Tel: +351 21 4232Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland Daiichi Sankyo Ireland Ltd Tel: +353-(0) 1 489 3Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Daiichi Sankyo Nordics ApS S mi: +354 5357Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia Daiichi Sankyo Italia S.p.A. Tel: +39-06 85 2Suomi/Finland Daiichi Sankyo Nordics ApS Puh/Tel: +358 (0) 9 3540 7

: +357 22490Sverige Daiichi Sankyo Nordics ApS Tel: +46 (0) 40 699 2Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) Daiichi Sankyo Europe GmbH Tel: +49 (0) 89 7808 0

This leaflet was last revised in {MM/YYYY}

This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: