Leaflet IMDYLLTRA 10mg powder for concentrate and solution for infusion


Indicated for: extensive-stage small cell lung cancer after platinum-based chemotherapy

Route of administration: infusion

Substance: tarlatamab (bispecific T-cell engager antibody)

ATC: L01FX33 (Antineoplastic and immunomodulating agents | Monoclonal antibodies and antibody drug conjugates | Other monoclonal antibodies and antibody drug conjugates)

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Immunosuppression / infection risk
Immunosuppression / infection risk

This medicine may increase the risk of infections.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Neuropathy / neurotoxicity
Neuropathy / neurotoxicity

This medicine may affect the nerves or nervous system.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Teratogenic / fetal risk
Teratogenic / fetal risk

This medicine may affect fetal development.

Tarlatamab is a cancer medicine used in adults with extensive-stage small cell lung cancer when the disease has progressed after platinum-based chemotherapy. It is a bispecific antibody that binds to DLL3 on tumour cells and to CD3 on T cells. By bringing these cells close together, it helps the immune system recognise and attack cancer cells.

Treatment is given as an intravenous infusion in a specialised oncology setting. The first doses require particularly close monitoring because important reactions are more likely early in treatment. Your healthcare team may give medicines before the infusion, provide fluids, perform blood tests and observe you in hospital or clinic after dosing. The exact schedule is decided by the oncology team.

The most important risks are cytokine release syndrome and neurologic reactions. Other possible side effects include tiredness, decreased appetite, altered taste, constipation, nausea, anaemia, low white blood cells, infections and changes in liver blood tests.

Patients and caregivers should know which symptoms require urgent medical help: fever, worsening shortness of breath, severe dizziness, confusion, sudden weakness, severe headache or signs of infection. Tarlatamab is not a routine medicine to take at home; it requires an experienced care team, structured monitoring and rapid reporting of any significant change in condition.

General data about IMDYLLTRA 10mg

  • Substance: tarlatamab
  • Commercial code: W71921001
  • Concentration: 10mg
  • Pharmaceutical form: powder for concentrate and solution for infusion
  • Product type: generic
  • Prescription restrictions: S - Medicines prescription reserved for use in certain specialized fields.

Marketing authorisation

  • Manufacturer: AMGEN EUROPE B.V. - TARILE DE JOS
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 1232/2026/01

Concentrations available for tarlatamab

  • 10mg
  • 1mg