Datroway

Package leaflet: Information for the patient

Datroway 100 mg powder for concentrate for solution for infusion

datopotamab deruxtecan
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read all of this leaflet carefully before you are given 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 you experience any side effects, including those not listed in this leaflet, tell 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 receiving 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 Datroway is and what it is used for

Datroway is a medicine that contains the active substance datopotamab deruxtecan.
Datroway is used to treat adults who have been diagnosed with a type of breast cancer known as
hormone receptor-positive (HR+), 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 previously received hormonal therapy and at least one additional anti-cancer treatment for unresectable or metastatic disease.
Part of the medicine is a monoclonal antibody (datopotamab) that specifically binds to cells expressing the TROP2 protein, which is present in high amounts on the surface of TROP2-expressing breast cancer cells. The other active component of Datroway is DXd, a substance capable of killing cancer cells. When the medicine binds to TROP2-expressing cancer cells, DXd enters the cells and kills them.

2. What you need to know before receiving Datroway

Do 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 unsure whether you are allergic, consult your doctor or nurse before receiving Datroway.
Warnings and precautions
Talk to your doctor or nurse before or during treatment with Datroway if you experience:

• cough, shortness of breath, fever, or new or worsening respiratory problems. These may be symptoms of a serious and potentially fatal 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, such as dry eyes, excessive tearing, light sensitivity, or changes in vision, during treatment, talk to your doctor or nurse. If necessary, your doctor may refer you to an ophthalmologist;
• mouth ulcers and sores. 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, inform your doctor or nurse. Follow your doctor’s or nurse’s instructions on how to use the mouthwash to prevent or treat mouth ulcers and sores.

If you have liver problems, your doctor may need to monitor you more closely during treatment with this medicine.
Children and adolescents
Datroway is not recommended for use in individuals under 18 years of age: there is no information available on its efficacy in this age group.
Other medicines and Datroway
Inform your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Contraception
You must use effective contraceptive measures to avoid becoming pregnant during treatment with Datroway and for a certain period after the last dose.

• Women receiving Datroway must continue using contraceptive measures for at least 7 months after the last dose of Datroway.
• Men receiving Datroway who have a partner of reproductive age must continue using effective contraception for at least 4 months after the last dose of Datroway.

Consult your doctor or nurse about the most appropriate contraceptive method for you. Also consult your doctor before stopping contraception.
Pregnancy
Datroway is not recommended during pregnancy because this medicine may harm the unborn baby. Contact your doctor immediately if you are pregnant, suspect you may be pregnant, or are planning a pregnancy before or during treatment.
Breast-feeding
You must not breastfeed during treatment with Datroway and for at least 1 month after the last dose, because it is not known whether Datroway passes into breast milk. Discuss this with your doctor.
Fertility
If you are being treated with Datroway, you should receive counseling on sperm or egg (oocyte) preservation before starting treatment, as this medicine may reduce fertility. Therefore, discuss this with your doctor before starting treatment.
Driving and using machines
Datroway may affect your ability to drive or operate machinery. Be cautious if you experience fatigue or have visual disturbances.
Datroway contains polysorbate 80
This medicine contains 1.5 mg of polysorbate 80 per vial. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How Datroway is administered

Datroway will be administered to you in a 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, given every 3 weeks. Your doctor or nurse will calculate the dose based on your body weight and determine the number of treatments required for you.
Your doctor or nurse will administer Datroway to you as an intravenous infusion (drip).
The first infusion will be given over 90 minutes. If this is well tolerated, subsequent infusions may be administered over 30 minutes.
After each infusion, you will be monitored for 30 minutes to detect any adverse reactions. Depending on any side effects you may experience, the doctor or nurse may reduce the dose or temporarily or permanently discontinue treatment.
Before each Datroway infusion, the doctor or nurse may give you medicines to help prevent nausea, vomiting, and infusion-related reactions.
Before each Datroway infusion and during the treatment period, the doctor or nurse may recommend using a mouthwash to help prevent the development of mouth ulcers and sores. If you experience infusion-related symptoms, the doctor or nurse may slow down the infusion or suspend or stop treatment.
During the treatment period, you must use a preservative-free lubricating eye drop several times a day and avoid wearing contact lenses.
If you miss an appointment for Datroway administration
Contact your doctor or treatment centre 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 questions 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 everyone gets them. If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
Some side effects can be serious and potentially fatal. Contact your doctor or nurse immediately if you notice any of the following:
Very common (may affect more than 1 in 10 people):

• Mouth ulcers and sores (stomatitis).
• Inflammation of the cornea (keratitis). Symptoms may include dry eyes, increased tear production, sensitivity to light, or changes in vision. Inflammation of the cornea (the transparent layer at the front of the eye covering the pupil and iris) may lead to ulceration.

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

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

Seeking immediate medical treatment may help prevent these problems from becoming more severe.
Other side effects
The frequency and severity of side effects may vary depending on the dose received. Inform 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 red blood cell levels (anemia), seen in blood tests
• increased levels of liver enzymes (aspartate aminotransferase) in the blood
• rash
• diarrhoea
• low neutrophil levels, a type of white blood cell that fights infections (neutropenia)
• increased levels of liver enzymes (alanine aminotransferase) in the blood

Common (may affect up to 1 in 10 people)

• redness and irritation of 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 (dyspnoea)
• altered taste (dysgeusia)
• dysfunction of the eyelid glands (Meibomian glands)
• change in skin colour (hyperpigmentation)
• blurred vision
• lung infection
• low levels of white blood cells that fight infections (leucopenia)
• loss of eyelashes (madarosis)
• abnormal sensitivity of the eyes to light
• tremors, fever, general discomfort, paleness or change in skin colour, 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 experience any side effect, including those not listed in this leaflet, talk to your healthcare professional. You can also report side effects directly via 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 will 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 stated on the outer carton and on the vial after Scad/EXP. The expiry date refers to the last day of that month.
• Store in the refrigerator (2 °C - 8 °C). Do not freeze.
• The prepared infusion solution is stable for up to 24 hours at a temperature of 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 proper disposal of unused Datroway. This will help protect the environment.

6. Package contents 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, a 5 mL solution vial contains 20 mg/mL of datopotamab deruxtecan.
• The other components are L-histidine, L-histidine monohydrochloride monohydrate, sucrose and polysorbate 80 (see section 2).

Description of the appearance of Datroway and contents of the pack
Datroway is a lyophilized powder, white to off-white in colour, supplied in a clear amber glass vial with a rubber stopper, aluminium seal and a plastic tamper-evident 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Daiichi Sankyo Belgium N.V.-S.A UAB AstraZeneca Lietuva
Tél/Tel: +32-(0) 2 227 18 80 Tel: +370 5 2660550

България Luxembourg/Luxemburg
АстраЗенека България ЕООД Daiichi Sankyo Belgium N.V.-S.A
Тел.: +359 24455000 Tél/Tel: +32-(0) 2 227 18 80

Česká republika Magyarország
AstraZeneca Czech Republic s.r.o. AstraZeneca Kft.
Tel: +420 222 807 111 Tel.: +36 1 883 6500

Danmark Malta
Daiichi Sankyo Nordics ApS Daiichi Sankyo Europe GmbH
Tlf.: +45 (0) 33 68 19 99 Tel: +49-(0) 89 7808 0

Deutschland Nederland
Daiichi Sankyo Deutschland GmbH Daiichi Sankyo Nederland B.V.
Tel: +49-(0) 89 7808 0 Tel: +31-(0) 20 4 07 20 72

Eesti Norge
AstraZeneca Daiichi Sankyo Nordics ApS
Tel: +372 6549 600 Tlf: +47 (0) 21 09 38 29

Ελλάδα Österreich
AstraZeneca A.E. Daiichi Sankyo Austria GmbH
Τηλ: +30 210 6871500 Tel: +43-(0) 1 4858642 0

España Polska
Daiichi Sankyo España, S.A. AstraZeneca Pharma Poland Sp. z o.o.
Tel: +34 91 539 99 11 Tel: +48 22 245 73 00

France Portugal
Daiichi Sankyo France S.A.S. Daiichi Sankyo Portugal, Unip. LDA
Tél: +33 (0) 1 55 62 14 60 Tel: +351 21 4232010

Hrvatska România
AstraZeneca d.o.o. AstraZeneca Pharma SRL
Tel: +385 1 4628 000 Tel: +40 21 317 60 41

Ireland Slovenija
Daiichi Sankyo Ireland Ltd AstraZeneca UK Limited
Tel: +353-(0) 1 489 3000 Tel: +386 1 51 35 600

Ísland Slovenská republika
Daiichi Sankyo Nordics ApS AstraZeneca AB, o.z.
Sími: +354 540 8000 Tel: +421 2 5737 7777

Italia Suomi/Finland
Daiichi Sankyo Italia S.p.A. Daiichi Sankyo Nordics ApS
Tel: +39-06 85 2551 Puh/Tel: +358 (0) 9 3540 7081

Κύπρος Sverige
Αλέκτωρ Φαρµακευτική Λτδ Daiichi Sankyo Nordics ApS
Τηλ: +357 22490305 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.

The following information is intended for healthcare professionals only:

Datroway contains a cytotoxic component and must be administered under the supervision of a
physician experienced in the use of antineoplastic and cytotoxic agents. Appropriate procedures must be used for the
preparation, handling, and disposal of antineoplastic and cytotoxic medicinal products.
Aseptic technique must be properly maintained during the reconstitution and dilution procedures described below.

Reconstitution

• Reconstitute immediately before dilution.
• More than one vial may be required for a complete dose. Calculate the required dose (mg), the total volume of reconstituted Datroway solution needed, and the number of Datroway vials required.
• Reconstitute each 100 mg vial by slowly injecting 5 mL of Water for Injections into the vial using a sterile syringe, to achieve a final concentration of 20 mg/mL.
• Gently swirl the vial until complete dissolution is achieved. Do not shake.
• If not used immediately, store reconstituted Datroway vials in a refrigerator at 2 °C to 8 °C for up to 24 hours, protected from light. Do not freeze.
• The reconstituted product contains no preservatives and is for single use only. Discard any unused reconstituted Datroway after 24 hours of refrigeration.

Dilution

• Withdraw the calculated amount from the vial (or vials) using a sterile syringe. Inspect the reconstituted solution for particulate matter and discoloration. The solution should be clear and colorless to pale yellow. Do not use if visible particles are present or if the solution is cloudy or discolored.
• Dilute the calculated volume of reconstituted Datroway in an infusion bag containing 100 mL of 5% glucose solution. Do not use sodium chloride solution. Use of a polyvinylchloride (PVC) or polyolefin (polypropylene (PP) or ethylene-propylene copolymer) infusion bag is recommended.
• Gently invert the infusion bag to ensure complete mixing. Do not shake.
• Cover the infusion bag to protect it from light.
• If not used immediately, store at room temperature (≤ 25 °C) for up to 4 hours, including preparation and infusion time, or store in a refrigerator at 2 °C to 8 °C for up to 24 hours, protected from light. Do not freeze.
• Discard any unused portion remaining in the vial.

Administration

• The maximum time between vial reconstitution and completion of administration must not exceed 24 hours. Discard the solution if storage time exceeds these limits.
• If the prepared infusion solution has been stored refrigerated (2 °C – 8 °C), allow it to reach room temperature before administration, protected from light.
• Administer Datroway as an intravenous infusion using only an infusion line and tubing made of PVC, polybutadiene (PBD), or low-density polyethylene (LDPE).
• Administer Datroway through an in-line filter made of polytetrafluoroethylene (PTFE), polyethersulfone (PES), or nylon 66 with a pore size of 0.2 micron.
• 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
Any unused medicinal product and waste materials derived from its use must be disposed of in accordance with
local regulations.