DATROWAY 100 mg Powder For Concentrate For Infusion Solution

Зміст інструкції

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

Datroway 100 mg powder for concentrate for solution for infusion

datopotamab 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 healthcare professional (doctor, pharmacist or nurse).
• If any side effects occur, including those not listed in this leaflet, ask your healthcare professional. See section 4.

Contents of this leaflet

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

1. What is Datroway and what is it used for

Datroway is a medicine that contains the active substance datopotamab deruxtecan.
Datroway is used for the treatment of adults who have been diagnosed with a type of cancer known as
hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2)
breast cancer. It is used when the cancer has spread to other parts of the body or cannot be removed
by surgery, in patients who have received hormonal therapy and at least one further anticancer treatment
for unresectable or metastatic disease.
One part of the medicine is a monoclonal antibody (datopotamab) that binds specifically to
cells that have the TROP2 protein, present in large quantities on the surface of
breast cancer cells that express TROP2. The other active part of Datroway is DXd, a substance
that can kill cancer cells. When the medicine binds to cancer cells that express
TROP2, DXd enters the cells and kills them.

2. What you need to know before you receive Datroway

You must not receive Datroway

• if you are allergic to datopotamab deruxtecan or to any of the other ingredients of this medicine (listed in section 6).

If you are not sure if you are allergic, consult your doctor or nurse before receiving Datroway.

Warnings and precautions
Talk to your doctor or nurse before receiving Datroway, or during treatment, if you
experience:

• cough, shortness of breath, fever, or new or worsening of other respiratory problems. These may be symptoms of a serious and potentially life-threatening lung disease called interstitial lung disease. A history of lung disease may increase the risk of developing interstitial lung disease. Your doctor may need to monitor your lungs during treatment with this medicine.

Datroway may also cause:

• eye problems. You should use a preservative-free lubricating eye drop several times a day to prevent dry eyes and other eye problems. You should avoid wearing contact lenses during treatment. If you have or develop eye problems, which may include dry eyes, increased tearing, sensitivity to light, or changes in vision, during treatment, talk to your doctor or nurse. If necessary, your doctor may refer you to an ophthalmologist;
• ulcers and sores in the mouth. In addition to good oral hygiene and dietary recommendations, your doctor or nurse will also recommend using an alcohol-free mouthwash 4 times a day. This mouthwash may contain steroids. If you experience pain, discomfort, or open sores in your mouth, tell your doctor or nurse. Follow your doctor's or nurse's instructions on how to use the mouthwash to prevent or treat ulcers and sores in the mouth.

If you have liver problems, your doctor may need to monitor you more closely during the
treatment with this medicine.

Children and adolescents
Datroway is not recommended for use in children and adolescents under 18 years of age: there is no information on its
effectiveness in this age group.

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

Contraception
You must use effective contraceptive measures (contraception) to avoid becoming pregnant
during treatment with Datroway and for a certain period after the last dose.

• Women who are taking Datroway must continue to use contraceptive measures for at least 7 months after the last dose of Datroway.
• Men who are taking Datroway with a fertile partner must continue to use effective contraceptive measures for at least 4 months after the last dose of Datroway.

Talk to your doctor or nurse about the best contraceptive measure for you. Also talk to your
doctor before stopping contraception.

Pregnancy
Datroway is not recommendedduring pregnancy because this medicine may harm the
unborn child. Tell your doctor immediately if you are pregnant, suspect you might be, or
are planning to become pregnant before or during treatment.

Breast-feeding
You must not breast-feedduring treatment with Datroway and for at least 1 month after
the last dose, because it is not known whether Datroway passes into breast milk. Talk to your doctor.

Fertility
If you are being treated with Datroway, you should receive advice on sperm or
egg (oocyte) preservation before treatment, because the medicine may reduce fertility. Therefore, talk to your doctor before starting treatment.

Driving and using machines
Datroway may affect your ability to drive or operate machines. Pay
attention if you feel tired or have vision problems.

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

3. How Datroway is administered

Datroway will be administered to you in hospital or clinic by a doctor or nurse experienced in the use
of anticancer medicines.
The recommended dose is 6 mg per kilogram of body weight, every 3 weeks. The doctor or
nurse will calculate the dose based on your body weight and decide the number of treatments necessary
for you.
The doctor or nurse will administer Datroway as an infusion (drip) into a vein.
The first infusion will be administered over 90 minutes. If this proceeds well, the infusion at the
subsequent visits may be administered over 30 minutes.
After each infusion, you will be monitored for 30 minutes to detect any adverse effects. The
doctor or nurse may reduce the dose or interrupt, temporarily or permanently, the
treatment depending on the adverse effects.
Before each Datroway infusion, the doctor or nurse may administer medicines that
help prevent nausea, vomiting and infusion-related reactions.
Before each Datroway infusion and during the treatment period, the doctor or nurse may
recommend the use of a mouthwash to help prevent the appearance of ulcers and sores in
the mouth. If infusion-related symptoms occur, the doctor or nurse may slow down
the infusion or suspend or interrupt the treatment.
During the treatment period, you must use a lubricating eye drop without preservatives several times
a day and avoid the use of contact lenses.

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

If you stop treatment with Datroway
Do not stop treatment with Datroway without consulting your doctor or nurse.
If you have any doubts about 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.
If you get any side effects, even if not listed in this leaflet, tell your doctor or nurse.
Some side effects can be serious and potentially life-threatening. Seek immediate medical attention
or contact your nurseif you notice any of the following:
Very common (may affect more than 1 in 10 people):

• Ulcers and sores in the mouth (stomatitis).
• Inflammation of the cornea (keratitis). Symptoms may include dry eyes, increased tearing, sensitivity to light, or changes in vision. Inflammation of the cornea (the clear layer at the front of the eye, covering the pupil and iris) can cause an ulcer.

Common (may affect up to 1 in 10 people):

• Interstitial lung disease. Symptoms may include cough, shortness of breath, fever, or new or worsening of other breathing problems.

Receiving immediate medical treatment can help prevent these problems from becoming more
serious.

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)
• fatigue (tiredness)
• hair loss (alopecia)
• constipation
• vomiting
• dry eye
• COVID-19
• low levels of red blood cells (anemia) observed in blood tests
• decreased appetite
• increased levels of liver enzymes (aspartate aminotransferase) in the blood
• rash
• diarrhea
• low levels of neutrophils, a type of white blood cells that fight infections (neutropenia)
• increased levels of liver enzymes (alanine aminotransferase) in the blood

Common(may affect up to 1 in 10 people)

• redness and discomfort in the eye (conjunctivitis)
• infusion-related reactions. These may include fever, chills, itching, or rash
• increased tear production
• infection of the parts of the body that collect and expel urine
• dry skin
• dry mouth
• itching
• inflammation of the eyelid (blepharitis)
• difficulty breathing (dyspnea)
• altered taste (dysgeusia)
• dysfunction of the eyelid glands (Meibomian glands)
• skin color change (hyperpigmentation)
• blurred vision
• lung infection
• low levels of white blood cells that fight infections (leukopenia)
• eyelash loss (madarosis)
• abnormal eye sensitivity to light
• tremors, fever, widespread discomfort, paleness or skin color change, shortness of breath due to an overload of bacteria in the bloodstream (sepsis)

Uncommon(may affect up to 1 in 100 people)

• impaired vision

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
healthcare professional. 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 Datroway

Datroway will be stored by healthcare professionals at the hospital or clinic where you receive your
treatment. The following information is intended for the doctor or nurse.

• 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 on the vial after Scad/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.

Applicable procedures for handling and disposal must be followed. The healthcare
professional is responsible for the correct disposal of unused Datroway. This will help to
protect the environment.

6. Contents of the pack and other information

What Datroway contains

• The active substance is datopotamab deruxtecan. One vial of powder for concentrate for solution for infusion contains 100 mg of datopotamab deruxtecan. After reconstitution, one 5 mL vial of solution contains 20 mg/mL of datopotamab deruxtecan.
• The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose and polysorbate 80 (see section 2).

Description of the appearance of Datroway and contents of the pack
Datroway is a lyophilized powder ranging in color from white to pale yellowish, 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 further information on 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 4858642 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: +354 540 8000

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

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency, https://www.ema.europa.eu .
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The following information is intended exclusively for healthcare professionals:
Datroway contains a cytotoxic component and must be administered under the supervision of a
physician experienced in the use of cytotoxic agents. Appropriate procedures must be used for the
correct preparation, handling and disposal of antineoplastic and cytotoxic medicinal products.
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 required volume of reconstituted Datroway solution and the number of Datroway vials needed.
• Reconstitute each 100 mg vial using a sterile syringe to slowly inject 5 mL of water for injections into each vial, in order to obtain a final concentration of 20 mg/mL.
• Gently rotate the vial until completely dissolved. Do not shake.
• If not used immediately, store reconstituted Datroway vials in a refrigerator at a temperature between 2 °C and 8 °C for a maximum of 24 hours, protected from light. Do not freeze.
• The reconstituted product does not contain preservatives and is for single use only. Discard unused reconstituted Datroway after 24 hours of refrigeration.

Dilution

• Withdraw the calculated amount from the vial(s) using a sterile syringe. Inspect the reconstituted solution for particulate matter and color change. The solution should be clear and colorless to pale yellow. Do not use if visible particles are observed or if the solution is cloudy or has a color change.
• Dilute the calculated volume of reconstituted Datroway in an infusion bag containing 100 mL of 5% glucose solution. Do not use sodium chloride solution. The use of a polyvinyl chloride (PVC) or polyolefin (polypropylene (PP) or ethylene propylene 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 (≤ 25 °C) for a maximum of 4 hours including preparation and infusion time, or in a refrigerator at a temperature between 2 °C and 8 °C for a maximum of 24 hours, protected from light. Do not freeze.
• Discard any unused portion remaining in the vial.

Administration

• The maximum time between reconstitution of the vial and the end of administration must not exceed 24 hours. Discard the solution if the storage time exceeds these limits.
• If the prepared 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 Datroway as an intravenous infusion only with an infusion line and tubing set made of PVC, polybutadiene (PBD) or low-density polyethylene (LDPE).
• Administer Datroway with an in-line filter made of polytetrafluoroethylene (PTFE), polyethersulfone (PES) or nylon 66 with a pore size of 0.2 microns.
• Do not administer as a rapid intravenous injection or bolus.
• Cover the infusion bag to protect it from light.
• Do not mix Datroway with other medicinal products and do not administer other medicinal products through the same infusion line.

Disposal
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in
accordance with local regulations.