IMDYLLTRA 1 milligram powder for concentrate and solution 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 have not previously been treated with two other types of treatments which did not or are no longer working.
• in children under 18 years of age (see details below).
• breast-feeding or planning to breast-feed (see details below).
• if the medicine is past its expiry date (see section 5).

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

Tarlatamab may cause serious side-effects such as shown below. If you have any questions, talk to your doctor 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) is when your body releases substances called cytokines into the blood. CRS is common and can be serious or life-threatening. Tell your doctor or get medical help immediately if you experience any signs and symptoms of CRS, including:
  • fever
  • low blood pressure (hypotension)
  • shortness of breath, trouble breathing
  • fast or irregular heartbeat: palpitations, dizziness
  • headache
  • chills
  • nausea
  • vomiting
• Immune effector cell-associated neurotoxicity syndrome (ICANS) is a syndrome of brain and nervous system that can cause brain related (neurologic) problems, which can be serious or life-threatening. These problems may happen days or weeks after you receive tarlatamab. Your doctor may refer you to a doctor who specialises in neurologic problems. Tell your doctor or get medical help immediately if you experience any signs or symptoms of neurologic problems, including:
  • trouble speaking, memory loss, personality changes (encephalopathy)
  • confusion
  • feeling disoriented or having difficulty thinking clearly (delirium)
  • seizure
  • loss of balance or coordination (ataxia)
  • weakness or numbness of arms and legs (neurotoxicity)
  • shakiness of your hands or limbs (tremor)
  • headache
  • Tiredness or feeling sleepy
• low white blood cell counts (neutropenia, lymphopenia):
  • chills or shivering
  • feel warm
  • high body temperature
• Allergic reactions (hypersensitivity) including but not limited to the following:
  • 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.

IMDYLLTRA has not been studied in children or adolescents. Treatment with IMDYLLTRA is 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 2 months 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 2 months after your last dose.

If you experience symptoms such as dizziness, seizures and confusion following IMDYLLTRA infusion, refrain from driving, and operating heavy or potentially dangerous machinery and engaging in hazardous occupations or activities until symptoms resolve.

IMDYLLTRA will be given to you by your doctor or nurse through a vein (intravenous) as a 1 hour infusion.

You will receive a smaller dose of 1 mg IMDYLLTRA on Day 1.

You will receive the full treatment dose of 10 mg IMDYLLTRA on Day 8, Day 15 and then every 2 weeks thereafter.

Within one hour before receiving your first two doses of IMDYLLTRA, you will be given a class of medicine called corticosteroids to help reduce your risk of CRS. 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 monitor you for 16 hours after the first infusion of IMDYLLTRA on Day 1). Your doctor will monitor you for signs and symptoms of CRS and neurologic problems during treatment with IMDYLLTRA, as well as other side effects, and treat you as needed. You may be hospitalised if you develop signs or symptoms of CRS or neurologic problems during treatment with IMDYLLTRA.

You should plan to stay within 1 hour travel time of the hospital for 24 hours from the start of each IMDYLLTRA infusion on Day 1 and Day 8 and have a caregiver with you.

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.

Your doctor will determine how long you should stay on 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.

You and your caregiver will be provided 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).

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 acid, and sodium hydroxide.
• The IV Solution Stabiliser contains citric acid monohydrate, lysine hydochloride, polysorbate 80, sodium hydroxide 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.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: