IMDYLLTRA 10 mg Powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

IMDYLLTRA is different to chemotherapy. IMDYLLTRA works with your immune system to find and destroy small cell lung cancer cells.

If you have any questions about how IMDYLLTRA works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.

• 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, pharmacist or nurse before you are given IMDYLLTRA.

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

• Cytokine Release Syndrome (CRS)
  • Fever
  • Low blood pressure (hypotension)
  • Shortness of breath: confusion, restlessness, trouble breathing
  • Fast or irregular heartbeat: palpitations, dizziness
  • Headache
  • Chills
  • Nausea
  • Vomiting
• Neurological problems – Immune effector cell-associated neurotoxicity syndrome (ICANS)
  • Headache
  • Trouble speaking, memory loss, personality changes (encephalopathy)
  • 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 (neurotoxicity)
  • Shakiness of your hands of limbs (tremor)
  • Tiredness or feeling sleepy
• Neutropenia (low white blood cell count)
  • Chills or shivering
  • Feel warm
  • High body temperature
• Allergic reaction (hypersensitivity)
  • Rash
  • Trouble breathing

Your doctor or nurse will monitor for signs and symptoms of these reactions during and after the infusion.

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

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

The effects of IMDYLLTRA in pregnant women are not known.

Tell your doctor or nurse if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby. Your doctor will help you weigh the benefits against the risk of taking IMDYLLTRA while you are pregnant.

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

Women who are able to become pregnant should use effective contraception during treatment and for at least 28 days after your last dose. Talk to your doctor or nurse about suitable methods of contraception.

It is not known whether the ingredients of IMDYLLTRA pass into breast milk. Tell your doctor or nurse if you are breast-feeding or are planning to breast-feed. You should not breast-feed during treatment with IMDYLLTRA and for at least 28 days after your last dose.

Refrain from driving, and operating heavy or potentially dangerous machinary and engaging in hazardous occupations or activities following IMDYLLTRA infusion, if there are ICANS-associated neurological symptoms, such as dizziness, seizures, and confusion, until these symptoms resolve.

IMDYLLTRA will be given to you through a vein (intravenous) as a 1-hour infusion.

IMDYLLTRA will be given on the following schedule: Day 1, Day 8, Day 15, and then every 2 weeks thereafter. One hour before receiving your first two doses of IMDYLLTRA you will be given a medicine call dexamethasone. This will be given to you by intravenous (IV) infusion into your vein. You may also get IV fluids after your first two doses of IMDYLLTRA.

Your doctor will determine how long you should stay on IMDYLLTRA.

Your doctor may delay of completely stop treatment with IMDYLLTRA if you have certain side effects.

Your doctor will monitor you for 16 hours after the first infusion of IMDYLLTRA (Day 1).

You should plan to stay within 1 hour of the hospital for 24 hours starting from each IMDYLLTRA infusion on Day 1 and Day 8 and have a caregiver with you. You and your caregiver will be given a Patient Alert Card (PAC) which contains instructions on the signs and symptoms of Cytokine Release Syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

After the third infusion (Day 15), and for all future infusions your doctor will provide information about how long you may need to be monitored after the infusion of IMDYLLTRA.

If you get any side effects, talk to your doctor or, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

or search for MHRA Yellow Card in the Google Play or Apple App Store

• The active substance is tarlatamab.
• The other ingredients are sucrose, polysorbate 80, L-glutamic acide, and sodium hydroxide.
• The IV Solution Stabiliser contains citric acid monohydrate, lysine hydochloride, polysorbate 80, sodium hydroxide to adjust pH to 7.0 and water for injection.

IMDYLLTRA is a powder for concentrate and solution for infusion.

• 1 mg pack contains: 1 glass vial of 1 mg IMDYLLTRA and 2 vials of 7 mL IV Solution Stabiliser.
• 10 mg pack contains: 1 glass vial of 10 mg IMDYLLTRA and 2 vials of 7 mL IV Solution Stabiliser.

Sterile Water for Injection (not included) should be used to reconstitute IMDYLLTRA.