InfoCons Consumer Protection informs you – IMDYLLTRA – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start using 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.

ℹ️ 1. What IMDYLLTRA is and what it is used for

IMD YLLTRA contains the active substance tarlatamab. It belongs to a group of medicines called antineoplastic agents which target cancer cells.

IMDYLLTRA is used in adults to treat small cell lung cancer (SCLC) that has spread throughout the lungs and/or to other parts of the body (extensive -stage SCLC) . It is used in adults whose cancer has not responded to or stopped responding to treatment with chemotherapy that contains platinum .

IMDYLLTRA is different from chemotherapy. The active substance in IMDYLLTRA , tarlatamab, works with your immune system to find and destroy small cell lung cancer cells. It works by connecting a protein called DLL3 found on the cancer cells and a protein called CD3 found on T -cells, a type of white blood cell. By linking these together, tarlatamab activates the T -cells, making them release substances that kill the cancer cells.

⚠️ 2. What you need to know before you use IMDYLLTRA

Do not use IMDYLLTRA

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

If you are not sure, talk to your doctor or nurse before you are given IMDYLLTRA.

Warnings and precautions

Tarlatamab may cause serious side effects such as shown below . If you have any questions, talk to your doctor before you are given IMDYLLTRA.

37 Talk to your doctor or nurse immediately if you experience any of the following while receiving IMDYLLTRA as they may need to treat the symptoms:

• Cytokine release syndrom e (CRS) is when your body releases substances called cytokines into the blood. CRS is very common and can be life-threatening or fatal . Tell your doctor or get medical help immediately if you experience any signs and symptoms of CRS, including :
• fever
• shortness of breath, trouble breathing
• fast or irregular heartbeat: palpitations
• dizziness
• headache
• chills
• nausea
• vomiting
• Immune effector cell -associated neurotoxicity syndrome (ICANS) is a life-threatening , potentially fatal condition that affects the brain and nervous system . These problems may happen days or weeks after you receive IMDYLLTRA . Tell your doctor or get medical help immediately if you experience any signs or symptoms of ICANS , including :
• trouble speaking
• memory loss
• altered or decreased consciousness
• confusion
• feeling disoriented or having the inability to think clearly (delirium)
• seizure
• loss of balance or coordination (ataxia)
• weakness or numbness of arms and legs
• shakiness of your hands o r limbs (tremor)
• headache
• Low levels of neutrophils, a type of white blood cell that fights infection (neutropenia) . Tell your doctor or get immediate medical help if you experience any signs or symptoms of infection, including:
• chills or shivering
• feeling warm
• high body temperature
• Allergic reactions (hypersensitivity) including excessive and prolonged contraction of the airway muscles causing breathing difficulty (bronchospasm). Tell your doctor or get immediate medical help if you develop signs or symptoms of allergic reactions including :
• rash
• difficulty breathing Your doctor or nurse will monitor for signs and symptoms of these reactions during and after the infusion and will inform you and your caregiver about the signs and symptoms of CRS and ICANS .

Children and adolescents

IMDYLLTRA has not been studied in children or adolescents. Treatment with IMDYLLTRA is not recommended in patients under 18 years of age.

Other medicines and IMDYLLTRA

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

38 Pregnancy , breast -feeding and contraception Tell your doctor or nurse if you are pregnant , think you may be pregnant or are planning to have a baby . IMDYLLTRA should not be used in pregnancy. This is because t he effects of IMDYLLTRA in pregnant women are not known . If you are a woman who can become pregnant, your doctor or nurse will check if you are pregnant before you start treatment with IMDYLLTRA.

Tell your doctor if you become pregnant during treatment with IMDYLLTRA . Your doctor may need to talk to you about the potential risks.

If you are able to become pregnant , you must use effective contraception (birth control) during treatment with IMDYLLTRA and for 2 months after your last dose. Talk to your doctor about suitable methods of contraception .

You should not breast -feed during treatment with IMDYLLTRA and for at least 2 months after your last dose. It is not known whether the ingredients in IMDYLLTRA pass into breast milk. Tell your doctor or nurse if you are breast -feeding or are planning to breast -feed.

Driving and using machines

IMDYLLTRA may have major effects on the ability to drive and use machines. This is due to symptoms which may be caused by immune effector cell -associated neurotoxicity syndrome (ICANS).

If you experience side effects affecting the nervous system , such as dizziness, seizures, and confusion after being given an IMDYLLTRA infusion, avoid driving, operating heavy or potentially dangerous machine s, and engaging in hazardous occupations or activities until they resolve.

IMDYLLTRA contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dos e, that is to say essentially ‘sodium – free’.

IMDYLLTRA contains polysorbate

This medicine contains 0.04 mg of polysorbate 80 in each 1 mg vial and 0.2 mg in each 10 mg vial .

Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How to use IMDYLLTRA

How IMDYLLTRA is given IMDYLLTRA will be given to you by your doctor or nurse by an infusion (drip) into a vein over 1 hour.

You will receive a dose of 1 mg IMDYLLTRA on day 1. You will receive the full treatment dose of 10 mg IMD YLLTRA on day 8, day 15 and then every 2 weeks thereafter.

Within o ne hour before receiving your first two doses of IMDYLLTRA , you will be given a class of medicine s called corticosteroids to help reduce your risk of CRS . This will be given to you by infusion (drip) into a vein. You may also get an infusion of fluids into a vein after your first two doses of IMDYLLTRA .

Your doctor will determine how long you should be treated with IMDYLLTRA .

Your doctor may delay or completely stop treatment with IMDYLLTRA if you develop CRS, neurologic problems, or any other side effects that are severe.

39 Monitoring after IMDYLLTRA infusion Your doctor will monitor you for 6 to 8 hours from the start of the IMDYLLTRA infusion on day 1 and day 8 in a healthcare facility. Your doctor w ill inform you if you have to be monitored for longer.

Your doctor or nurse will monitor you for signs and symptoms of CRS and side effects affecting the nervous system during treatment with IMDYLLTRA, as well as other side effects, and treat you as needed. You may be hospitali sed if you develop signs or symptoms of CRS or neurologic problems during treatment with IMDYLLTRA.

You should plan to stay within proximity of a healthcare facility for 24 hours from the start of each IMDYLLTRA infusion on day 1 and day 8 and have a caregiver with you.

For all future infusions , your doctor will inform you about how long you may need to be monitored after the infusion of IMDYLLTRA .

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor immediately if you get any of the following side effects:

• very common: sudden and severe inflammatory syndrome with symptoms including fever, chills, low blood oxygen, headache, decreased blood pressure, nausea, or vomiting – these may be signs of cytokine release syndrome (CRS ).
• common : shaking (or tremor), confusion, disturbances of brain function (encephalopathy), difficulty in communicating (aphasia), seizure (convulsion) – these may be signs of immune effector cell -associated neurotoxicity syndrome (ICANS) .

Other possible side effects The following other side effects have been reported with IMDYLLTRA:

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

• decreased appetite
• fever (pyrexia)
• bad taste in mouth (dysgeusia)
• constipation
• decreased levels of red blood cells (an aemia)
• tiredness (fatigue)
• feeling sick ( nausea )
• physical weakness or lack of energy (asthenia)
• headache
• decreased levels of neutrophils , a type of white blood cell that fights infection (neutropenia )
• low levels of lymphocytes, a type of white blood cell (lymphopenia)
• weight decreased
• vomiting
• dry or wet cough, shortness of breath (dyspn oea)
• diarrhoea
• increased levels of liver enzymes ( alanine aminotransferase increased )
• itchiness (pruritus)
• low level s of sodium in blood (hyponatraemia)
• low level s of potassium in blood (hyp okalaemia) 40 Common (may affect up to 1 in 10 people):
• increased levels of liver enzymes ( aspartate aminotransferase increased )
• low level of magnesium in blood (hypomagnesaemia)
• dizziness
• rash
• decreased levels of platelets , components that help the blood to clot (thrombocytopenia)
• low blood pressure
• high blood pressure
• muscle pain (myalgia)
• white blood cell count decreased
• decreased levels of certain white blood cells (leukopenia)
• chills
• confusion (confusional state)
• shakiness of hands and limbs (tremor)
• feeling disoriented (delirium)

Uncommon (may affect up to 1 in 100 people)

• change in normal activity of nervous system (neurotoxicity)
• seizure
• loss of balance or coordination (ataxia)
• trouble speaking, memory loss, personality changes (encephalopathy)

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.

🌡️ 5. How to store IMDYLLTRA

IMDYLLTRA will be stored by the healthcare professionals at the hospital or clinic.

Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP .

The expiry date refers to the last day of that month.

Unopened vials

• Store and transport refrigerated (2° C to 8°C).
• Do not freeze.
• Store in the original packaging in order to protect from light.

Prepared IMDYLLTRA (infusion bag)

• Once at room temperature (20° C to 25°C), store no longer than 8 hours.
• When refrigerated (2°C to 8°C) , the infusion bag must be used within 28 days.

📦 6. Contents of the pack and other information

What IMDYLLTRA contains

• The active substance is tarlatamab .
• IMDYLLTRA 1 mg: each vial contains 1 mg of tar latamab. Reconstitution with water for injections results in a final tarlatamab concentration of 0.9 mg/mL.
• IMDYLLTRA 10 mg: each vial contains 10 mg of tarlatamab. Reconstitution with water for injections results in a final tarlatamab concentration of 2.4 mg/mL.

41 – The other ingredients in the powder are glutamic acid, sucrose, polysorbate 80, and sodium hydroxide (see section 2).

• The solution (stabiliser) contains citric acid monohydrate, lysine hydrochloride , polysorbate 80, sodium hydroxide , and w ater for injection s (see section 2).

What IMDYLLTRA looks like and contents of the pack

IMDYLLTRA is a powder for concentrate and solution for solution for infusion . Each pack contains 1 glass vial of powder and 2 vials of 7 mL solution (stabiliser) .

Marketing Authorisation Holder and Manufacturer

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda The Netherlands

Marketing Authorisation Holder

Amgen Europe B.V.

Minervum 7061 4817 ZK Breda The Netherlands

Manufacturer

Amgen NV Telecomlaan 5 -7 1831 Diegem Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien s.a. Amgen n.v.

Tél/Tel: +32 (0)2 7752711 Lietuva Amgen Switzerland AG Vilniaus filialas Tel: + 370 5 219 7474 България Амджен България ЕООД Тел.: +359 (0)2 424 7440 Luxembourg/Luxemburg s.a. Amgen Belgique/Belgien Tél/Tel: +32 (0)2 7752711 Česká republika Amgen s.r.o.

Tel: +420 221 773 500 Magyarország Amgen Kft.

Tel.: +36 1 35 44 700 Danmark Amgen, filial af Amgen AB, Sverige Tlf.: +45 39617500 Malta Amgen S.r.l.

Italy Tel: +39 02 6241121 Deutschland Amgen GmbH Tel: +49 89 1490960 Nederland Amgen B.V.

Tel: +31 (0)76 5732500 Eesti Amgen Switzerland AG Vilniaus filialas Tel: + 372 586 09553 Norge Amgen AB Tlf: +47 23308000 42 Ελλάδα Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.

Τηλ: +30 210 3447000 Österreich Amgen GmbH Tel: +43 (0)1 50 217 España Amgen S.A.

Tel: +34 93 600 18 60 Polska Amgen Biotechnologia Sp. z o.o.

Tel.: +48 22 581 3000 France Amgen S.A.S.

Tél: +33 (0)9 69 363 363 Portugal Amgen Biofarmacêutica, Lda.

Tel: +351 21 4220606 Hrvatska Amgen d.o.o.

Tel: +385 (0)1 562 57 20 România Amgen România SRL Tel: +4021 527 3000 Ireland Amgen Ireland Limited Tel: +353 1 8527400 Slovenija AMGEN zdravila d.o.o.

Tel: +386 (0)1 585 1767 Ísland Vistor Sími: +354 535 7000 Slovenská republika Amgen Slovakia s.r.o.

Tel: +421 2 321 114 49 Italia Amgen S.r.l.

Tel: +39 02 6241121 Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900500 Kύπρος C.A. Papaellinas Ltd Τηλ: +357 22741 741 Sverige Amgen AB Tel: +46 (0)8 6951100 Latvija Amgen Switzerland AG Rīgas filiāle Tel: +371 257 25888

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu . There are also links to other websites about rare diseases and treatments.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website. ————————————————————————————————————————

🩺 Information intended for healthcare professionals only

The recommended dos ing schedule of IMDYLLTRA is an initial dose of 1 mg on day 1 followed by 10 mg on days 8, 15, and every 2 weeks (see table 1). IMDYLLTRA should be infused over 1 hour at an infusion rate of 250 mL/hour.

43 Table 1. Recommended dos ing schedule of IMDYLLTRA Dose of IMDYLLTRA Day 1 1 mg Day 8 10 mg Day 15 and every 2 weeks thereafter 10 mg IMDYLLTRA is to be reconstituted and then further diluted prior to administration by intravenous infusion.

Reconstitute IMDYLLTRA with water for injections. Do not reconstitute IMDYLLTRA vials with the solution (stabiliser).

For instructions on the reconstitution and dilution of the medicinal product before administration, see below .

Aseptic preparation Strictly observe aseptic technique when preparing the solution for infusion since tarlatamab vials do not contain antimicrobial preservatives.

Other instructions

• Reconstitution of IMDYLLTRA is with water for injections. Do not use the solution (stabiliser) to reconstitute IMDYLLTRA. The solution (stabiliser) is used to coat the infusion bag prior to addition of reconstituted IMDYLLTRA to prevent adsorption of IMDYLLTRA to infusion bags and infusion line.
• Infusion bags composed of ethyl vinyl acetate (EVA), polyolefin, and polyvinyl chloride (PVC) have been shown to be compatible with tarlatamab at the specified administration conditions.
• Infusion line and catheter materials composed of polyolefin, PVC, and polyurethane have been shown to be compatible with tarlatamab at the specified administration conditions.
• The use of Closed System Transfer Device (CSTD) is not recommended due to potential risk for medication error. Compatibility testing of vial adaptor CSTDs with IMDYLLTRA has not been performed.

Preparation of the solution for infusion Reconstitution of tarlatamab Table 2. Required amount of water for injections to reconstitute IMDYLLTRAa IMDYLLTRA vial strength Amount of water for injections needed to reconstitute IMDYLLTRA Final concentration 1 mg 1.3 mL 0.9 mg/mL 10 mg 4.4 mL 2.4 mg/mL a Each vial contains an overfill to allow for withdrawal of 1.1 mL (1 mg vial) or 4.2 mL (10 mg vial) after reconstitution to ensure delivery at the stated concentration of labelled vial strength.

1. Transfer required amount of water for injections (refer to table 2) into the tarlatamab vial to provide a final tarlatamab concentration of 0.9 mg/mL (1 mg vial) or 2.4 mg/mL (10 mg vial).

Direct the water along the walls of the IMDYLLTRA vial and not directly on the lyophili sed powder.

• Do not use the solution (stabiliser) to reconstitute IMDYLLTRA.

44 2. Gently swirl contents. Do not shake.

3. Visually inspect that the solution is clear to slightly opalescent, colourless to slightly yellow. Do not use if solution is cloudy o r has particulates.

Preparation of IMDYLLTRA infusion bag Table 3. Preparation guide for 1 -hour infusion IMDYLLTRA vial strength IMDYLLTRA dose Volume of sodium chloride 9 mg/mL (0.9%) solution for injection to withdraw from infusion bag Volume of solution (stabiliser) to add to infusion bag Volume of reconstituted tarlatamab to add to infusion bag 1 mg 1 mg 14 mL 13 mL 1.1 mL 10 mg 10 mg 17 mL 13 mL 4.2 mL Note: the final concentrations for the different strength vials are NOT the same following reconstitution.

1. Use an infusion bag pre -filled with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection .

2. Withdraw the required volume of sodium chloride 9 mg/mL (0.9%) solution for injection from the pre -filled infusion bag and discard (refer to table 3). Disregard any overfill in the infusion bag.

3. Add solution (stabiliser).

• To coat the infusion bag, transfer 13 mL of the solution (stabiliser) to the infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
• Gently mix the contents of the bag to avoid foaming. Do not shake.

4. Add reconstituted IMDYLLTRA.

• Transfer the required volume of reconstituted IMDYLLTRA into the stabilised infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection and the solution (stabiliser). Refer to table 3.
• Gently mix the contents of the bag to avoid foaming. Do not shake.

5. Remove the air from the infusion bag using an empty syringe to avoid foaming.

6. Prime infusion line with sodium chloride 9 mg/mL (0.9%) solution for injection or final prepared product.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Method of administration The infusion line for premedication can be used for IMDYLLTRA. An infusion line flush should be conducted between administering concomitant medicinal products and IMDYLLTRA.

Administer the entire contents of tarlatamab as an intravenous infusion over 1 hour at a constant flow rate using an infusion pump. The pump should be programmable, lockable, non -elastomeric, and have an alarm.

The infusion line is primed with sodium chloride 9 mg/mL (0.9%) solution for injection OR final prepared tarlatamab.

IMDYLLTRA should be infused over 1 hour at an infusion rate of 250 mL/hour.

Upon completion of the IMDYLLTRA infusion, the intravenous infusion line should be flushed over 3-5 minutes using sodium chloride 9 mg/mL (0.9%) solution for injection .

45 Storage conditions and shelf life Unopened vial 4 years .

Diluted solution for intravenous infusion (infusion bag) Chemical and physical in -use stability has been demonstrated for 28 days at 2°C to 8°C and 8 hours at 20°C to 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in -use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the method of reconstitution and dilution has taken place in controlled and validated aseptic conditions.

The storage time includes total time permitted from point of reconstitution of first vial to the end of administration. After removal from refrigeration, allow the infusion bag to reach room temperature and complete administration of the diluted IMDYLLTRA infusion solution within the allowable room temperature storage time (including infusion time). If the prepared tarlatamab infusion bag is not administered within the time frames and temperatures indicated, it must be discarded; it should not be refrigerated again.

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information IMDYLLTRA (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/26/2033).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.