ENHERTU 100 mg Proszek Do Sporządzania Koncentratu Do Roztworu Infuzyjnego

Treść ulotki

1. Enhertu 100 mg powder for concentrate for solution for infusion
   1. What is Enhertu and what is it used for
   2. What you need to know before you receive Enhertu
   3. How Enhertu is administered
   4. Possible side effects
   5. How to store Enhertu
   6. Contents of the pack and other information

Enhertu 100 mg powder for concentrate for solution for infusion

trastuzumab deruxtecan

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you receive this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or nurse.
If any side effects occur, including those not listed in this leaflet, tell your
doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Enhertu and what is it used for

What is Enhertu
Enhertu is an anticancer medicine that contains the active substance trastuzumab deruxtecan. One
part of the medicine is a monoclonal antibody that binds specifically to cells that
display the HER2 protein on their surface (HER2-positive), as occurs in some tumor cells. The other active part of Enhertu is DXd, a substance that kills tumor cells. When the
medicine binds to HER2-positive tumor cells, DXd enters the cells and kills them.

What is Enhertu used for
Enhertu is used for the treatment of adults who have:
a HER2-positive breast cancerthat has spread to other parts of the body (metastatic
disease) or that cannot be removed by surgery and who have previously received one or more other treatments specifically for HER2-
positive breast cancer.
a breast cancer with low levels of HER2 expression(HER2 low or HER2-
ultralow) that has spread to other parts of the body (metastatic disease) or that cannot be
removed by surgery and who have received previous therapy. A test will be performed to verify that Enhertu is the right therapy for you.
a non-small cell lung cancerHER2-mutatedthat has spread to other parts of the
body or that cannot be removed by surgery and who have received a
previous treatment. A test will be performed to verify that Enhertu is the appropriate therapy
for you.
a HER2-positive stomach cancerthat has spread to other parts of the body or areas near
the stomach that cannot be removed by surgery and who have also previously received another treatment specifically for HER2-
positive stomach cancer.

2. What you need to know before you receive Enhertu

You must not receive Enhertu
if you are allergic to trastuzumab deruxtecan or to any of the other ingredients of this
medicine (listed in section 6).
If you are not sure if you are allergic, ask your doctor or nurse before receiving Enhertu.

Warnings and precautions
Talk to your doctor or nurse before receiving Enhertu, or during treatment, if you
experience:
cough, shortness of breath, fever or new onset or worsening of respiratory 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 need to monitor your lungs during treatment with this medicine;
chills, fever, mouth sores, 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 onset or worsening of shortness of breath, cough, fatigue, swelling of the
ankles or legs, irregular heartbeat, sudden weight gain, dizziness or
loss of consciousness. These may be symptoms of a condition in which the heart is unable to
pump enough blood (reduced left ventricular ejection fraction);
liver problems. Your doctor may need to monitor your liver during treatment
with this medicine.
Your doctor will perform tests before and during treatment with Enhertu.

Children and adolescents
Enhertu is not recommended for use in children and adolescents under 18 years of age, as there is no information on its
effectiveness 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, breastfeeding, contraception and fertility
Pregnancy
Enhertu is not recommendedduring pregnancy because this medicine may harm
the unborn child.
Tell your doctor immediately if you are pregnant, suspect you might be pregnant or are planning
a pregnancy before or during treatment.

Breastfeeding
You must not breastfeed with breast milkduring treatment with Enhertu and for at least 7 months
after the last dose, because it is not known whether Enhertu passes into breast milk. Talk to your doctor.

Contraception
Use effective contraceptive measures (contraception) to avoid becoming pregnant
during treatment with Enhertu.
Women taking Enhertu must continue to use contraceptive measures for at least
7 months after the last dose of Enhertu.
Men taking Enhertu with a fertile partner must use effective contraceptive measures:

• during treatment and
• for at least 4 months after the last dose of Enhertu.

Talk to your doctor about the best contraceptive measure for you. Talk to your doctor also
before stopping contraception.

Fertility
Men treated with Enhertu should not have intercourse aimed at procreation
for 4 months after the end of treatment and should receive counseling on sperm preservation before treatment, because the medicine may reduce fertility. Therefore, talk to
your doctor before starting treatment.

Driving and operating machinery
It is unlikely that Enhertu will affect your ability to drive or operate machinery. Be careful
if you experience fatigue, dizziness or headache.

Enhertu contains polysorbate 80
This medicine contains 1.5 mg of polysorbate 80 per vial of 100 mg.
Polysorbates can cause allergic reactions. Tell your doctor if you have known allergies.

3. How Enhertu is administered

Enhertu will be administered to you in hospital or clinic.
The recommended dose of Enhertu for the treatment of:
HER2-positive, HER2-low or HER2-ultralow breast cancer is 5.4 mg per each
kilogram of weight, every 3 weeks;
HER2-mutated non-small cell lung cancer is 5.4 mg per each kilogram
of weight, every 3 weeks;
HER2-positive gastric cancer is 6.4 mg per each kilogram of weight, every
3 weeks.
The doctor or nurse will administer Enhertu to you with an infusion (drip) into a vein.
The first infusion will be administered over 90 minutes. If this proceeds well,
the infusion at subsequent visits may be administered over 30 minutes.
The doctor will decide the number of treatments necessary for you.
Before each Enhertu infusion, the doctor may administer medications that help to
prevent nausea and vomiting.
If infusion-related symptoms occur, the doctor or nurse may slow down the infusion
or suspend or discontinue treatment.
Before and during treatment with Enhertu, the doctor will perform tests, which may
include:
blood tests to check blood cells, liver and kidneys;
tests to check the heart and lungs.
The doctor may reduce the dose or discontinue, temporarily or permanently, treatment
depending on side effects.

If you miss an appointment for Enhertu administration
Contact your doctor immediately to reschedule the appointment.
It is very important not to miss a dose of this medicine.

If you stop treatment with Enhertu
Do not stop treatment with Enhertu without consulting your doctor.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effect, even if not listed in this leaflet, tell your doctor.

Consult your doctor immediatelyif you notice any of the following symptoms, which may be
signs of a serious, potentially life-threatening condition. Receiving immediate medical treatment can
help prevent these problems from becoming more severe.

Very common(may affect more than 1 in 10 people)
A lung disease called interstitial lung disease, with symptoms that may
include cough, shortness of breath, fever, or new onset or worsening of other
respiratory problems.
An infection caused by a reduced number of neutrophils (a type of white blood cells), with symptoms
that may include chills, fever, mouth sores, stomach pain, or pain when
urinating.
A heart problem called left ventricular dysfunction, with symptoms that may
include new onset or worsening of shortness of breath, cough, fatigue, swelling
of the ankles or legs, irregular heartbeat, sudden weight gain, dizziness, or
loss of consciousness.

Other side effects
The frequency and severity of side effects can vary depending on the dose 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
fatigue
decreased appetite
blood tests showing a decrease in red blood cells or white blood cells or
platelets
hair loss
diarrhea
constipation
blood tests showing an increase in liver enzyme levels such as
transaminases
muscle and bone pain
abdominal pain (stomach pain)
fever
weight loss
lung infection
infections of the nose and throat, including flu-like symptoms
headache
blisters inside the mouth or around the mouth
cough
blood tests showing low potassium levels
swelling of the ankles and feet
indigestion
difficulty breathing
unpleasant/altered taste in mouth

Common(may affect up to 1 in 10 people)
nosebleeds
dizziness
skin rash
blood tests showing an increase in bilirubin, alkaline phosphatase, or
creatinine
blood tests showing a decrease in red blood cells, white blood cells, and
platelets (pancytopenia)
itching
dry eye
change in skin color
blurred vision
feeling thirsty, dry mouth
bloated stomach
fever accompanied by a reduction in the number of white blood cells called neutrophils
inflammation of the stomach
excess gas in the stomach or intestines
reactions related to the infusion of the medicine, which may include fever, chills, redness,
itching, or rash

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national
reporting system listed in Annex V. 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 your
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 packaging and vial after Exp./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 infusion solution is stable for a period of up to 24 hours at a temperature between 2 °C - 8 °C, protected from light, and must then be discarded. Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help 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 5 mL vial of solution contains 20 mg/mL of trastuzumab deruxtecan.
• The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, polysorbate 80. Description of the appearance of Enhertuand contents of the packEnhertu is a lyophilized powder of white to pale yellow color, supplied in a transparent amber glass vial, with a rubber stopper, aluminum seal and a plastic tear-off closure cap. Each pack contains 1 vial.

Marketing Authorisation Holder
Daiichi Sankyo Europe GmbH
Zielstattstrasse 48
81379 Munich
Germany

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen
Germany
For any information regarding this medicinal product, please contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Daiichi Sankyo Belgium N.V.-S.A
Tél/Tel: +32-(0) 2 227 18 80

Lietuva
UAB AstraZeneca Lietuva
Tel: +370 5 2660550

България
АстраЗенека България ЕООД
Тел.: +359 24455000

Luxembourg/Luxemburg
Daiichi Sankyo Belgium N.V.-S.A
Tél/Tel: +32-(0) 2 227 18 80

Česká republika
AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111

Magyarország
AstraZeneca Kft.
Tel.: +36 1 883 6500

Danmark
Daiichi Sankyo Nordics ApS
Tlf.: +45 (0) 33 68 19 99

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 72

Eesti
AstraZeneca
Tel: +372 6549 600

Norge
Daiichi Sankyo Nordics ApS
Tlf: +47 (0) 21 09 38 29

Ελλάδα
AstraZeneca A.E.
Τηλ: +30 210 6871500

Österreich
Daiichi Sankyo Austria GmbH
Tel: +43 (0) 1 485 86 42 0

España
Daiichi Sankyo España, S.A.
Tel: +34 91 539 99 11

Polska
AstraZeneca Pharma Poland Sp. z o.o.
Tel: +48 22 245 73 00

France
Daiichi Sankyo France S.A.S.
Tél: +33 (0) 1 55 62 14 60

Portugal
Daiichi Sankyo Portugal, Unip. LDA
Tel: +351 21 4232010

Hrvatska
AstraZeneca d.o.o.
Tel: +385 1 4628 000

România
AstraZeneca Pharma SRL
Tel: +40 21 317 60 41

Ireland
Daiichi Sankyo Ireland Ltd
Tel: +353-(0) 1 489 3000

Slovenija
AstraZeneca UK Limited
Tel: +386 1 51 35 600

Ísland
Daiichi Sankyo Nordics ApS
Sími: +354 5357000

Slovenská republika
AstraZeneca AB, o.z.
Tel: +421 2 5737 7777

Italia
Daiichi Sankyo Italia S.p.A.
Tel: +39-06 85 2551

Suomi/Finland
Daiichi Sankyo Nordics ApS
Puh/Tel: +358 (0) 9 3540 7081

Κύπρος
Αλέκτωρ Φαρµακευτική Λτδ
Τηλ: +357 22490305

Sverige
Daiichi Sankyo Nordics ApS
Tel: +46 (0) 40 699 2524

Latvija
SIA AstraZeneca Latvija
Tel: +371 67377100
An authorisation has been granted for this medicinal product under exceptional circumstances. This means that
further data on this medicinal product are being collected.
The European Medicines Agency will review the new information at least annually.

Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website,
https://www.ema.europa.eu.
-------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for healthcare professionals:
In order to avoid medication errors, check the vial labels to ensure that the
medicinal product you are preparing and administering is Enhertu (trastuzumab deruxtecan) and not
trastuzumab or trastuzumab emtansine.
Appropriate procedures for the preparation of chemotherapeutic agents must be used. Adequate aseptic technique must
be used for the following reconstitution and dilution procedures.

Reconstitution

• Reconstitute immediately before dilution.
• More than one vial may be required for a full dose. Calculate the dose (mg), the total volume required of reconstituted Enhertu solution and the number of Enhertu vials needed.
• Reconstitute each 100 mg vial using a sterile syringe to slowly inject 5 mL of water for injections into each vial, to obtain a final concentration of 20 mg/mL.
• Gently rotate the vial until completely dissolved. Do not shake.
• From a microbiological point of view, the medicinal product must be used immediately. If not used immediately, the chemical and physical stability in use has been demonstrated for a period of up to 48 hours at a temperature between 2 °C and 8 °C. Store reconstituted Enhertu vials in a refrigerator at a temperature between 2 °C and 8 °C, protected from light. Do not freeze.
• The reconstituted product does not contain preservatives and is for single use only.

Dilution

• Withdraw the calculated amount from the vial(s) using a sterile syringe. Inspect the reconstituted solution for particulate matter or colour change. The solution should be clear and colourless to pale yellow. Do not use if visible particles are observed or if the solution is cloudy or discoloured.
• Dilute the calculated volume of reconstituted Enhertu in an infusion bag containing 100 mL of 5% glucose solution for infusion. Do not use sodium chloride solution. A polyvinyl chloride or polyolefin (ethylene and polypropylene copolymer) infusion bag is recommended.
• Gently invert the infusion bag to thoroughly mix the solution. Do not shake.
• Cover the infusion bag to protect it from light.
• If not used immediately, store at room temperature (≤ 30 ºC) for up to 4 hours including preparation and infusion time, or in a refrigerator at a temperature between 2 °C and 8 °C for up to 24 hours, protected from light. Do not freeze.
• Discard any unused portion remaining in the vial. Administration
• If the infusion solution has been stored in a refrigerator (2 °C - 8 °C), it is recommended to allow it to reach room temperature before administration, protected from light.
• Administer Enhertu as an intravenous infusion only with a 0.20 or 0.22 micron polyethersulfone (PES) or polysulfone (PS) in-line filter.
• The initial dose must be administered by intravenous infusion over a duration of 90 minutes. If the previous infusion has been well tolerated, subsequent doses of Enhertu may be administered as infusions lasting 30 minutes. Do not administer as a rapid intravenous injection or bolus.
• Cover the infusion bag to protect it from light.
• Do not mix Enhertu with other medicines and do not administer other medicines through the same infusion line. DisposalUnused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.