IMDYLLTRA Powder for solution for infusion Ref.[116661] Active ingredients: Tarlatamab

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Product name and form

IMDYLLTRA 1 mg powder for concentrate and solution for solution for infusion.

IMDYLLTRA 10 mg powder for concentrate and solution for solution for infusion.

Pharmaceutical Form

Powder for concentrate and solution for solution for infusion.

Tarlatamab powder (powder for concentrate): White to slightly yellow powder.

Solution (stabiliser): Colourless-to-slightly yellow, clear solution with a pH of 7.0.

Qualitative and quantitative composition

IMDYLLTRA 1 mg powder for concentrate and solution for solution for infusion:

One vial of powder contains 1 mg of tarlatamab.

Reconstitution with water for injections results in a final tarlatamab concentration of 0.9 mg/mL.

IMDYLLTRA 10 mg powder for concentrate and solution for solution for infusion:

One vial of powder contains 10 mg of tarlatamab.

Reconstitution with water for injections results in a final tarlatamab concentration of 2.4 mg/mL.

Tarlatamab is produced in Chinese hamster ovary cells by recombinant DNA technology.

Excipient with known effect:

IMDYLLTRA contains 0.04 mg polysorbate 80 in each 1 mg vial and 0.2 mg polysorbate 80 in each 10 mg vial.

For the full list of excipients, see section 6.1.

Active Ingredient

Tarlatamab is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T-cell engager that binds to DLL3 expressed on the surface of tumour cells and CD3 expressed on the surface of T-cells. The bispecific binding of tarlatamab to T-cells and DLL3-positive tumour cells triggers T-cell activation, production of inflammatory cytokines, and release of cytotoxic proteins, which results in redirected lysis of tumour cells.
List of Excipients

Powder:

Glutamic acid
Sucrose
Polysorbate 80 (E433)
Sodium hydroxide (for pH-adjustment)

Solution (stabiliser):

Citric acid monohydrate (E330)
Lysine hydrochloride
Polysorbate 80 (E433)
Sodium hydroxide (for pH-adjustment)
Water for injections

Pack sizes and marketing

IMDYLLTRA consists of two packaging configurations. Each IMDYLLTRA pack contains 1 vial of powder for concentrate for solution for infusion and 2 vials of solution (stabiliser).

IMDYLLTRA 1 mg powder for concentrate and solution for solution for infusion:

  • 1 mg tarlatamab powder in a Type 1 glass vial with an elastomeric stopper, aluminium seal and a grey flip-off cap
  • 7 mL solution in a Type 1 glass vial with an elastomeric stopper, aluminium seal and a white flip-off cap

IMDYLLTRA 10 mg powder for concentrate and solution for solution for infusion:

  • 10 mg tarlatamab powder in a Type 1 glass vial with an elastomeric stopper, aluminium seal and an orange flip-off cap
  • 7 mL solution in a Type 1 glass vial with an elastomeric stopper, aluminium seal and a white flip-off cap

Marketing authorization holder

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Marketing authorization dates and numbers

EU/1/26/2033/001
EU/1/26/2033/002

Drugs

Drug Countries
IMDYLLTRA Lithuania
 
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