Leaflet IMDYLLTRA 1mg powder for concentrate and solution for infusion

Product code:
W71922001
Quantity:
1
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

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

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Hepatotoxicity

This medicine may affect the liver.

Immunosuppression / infection risk

This medicine may increase the risk of infections.

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Neuropathy / neurotoxicity

This medicine may affect the nerves or nervous system.

Pregnancy warning

Use during pregnancy only on medical advice.

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 1mg

Substance:
tarlatamab
Product code:
W71922001
Concentration:
1mg
Pharmaceutical form:
powder for concentrate and solution for infusion
Quantity:
1
Product type:
Generic medicine
Prescription status:
S — Medicines dispensed with a restricted medical 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:
1231/2026/01

Concentrations available for tarlatamab

  • 10mg
  • 1mg