Tarlatamab: package leaflet

injection.

the pre-filled infusion bag and discard (refer to table 3). Disregard any overfill in the infusion bag.

• To coat the infusion bag, transfer 13 mL of the solution (stabiliser) to the infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection.
• Gently mix the contents of the bag to avoid foaming. Do not shake.

• Transfer the required volume of reconstituted IMDYLLTRA into the stabilised infusion bag containing sodium chloride 9 mg/mL (0.9%) solution for injection and the solution (stabiliser). Refer to table 3.
• Gently mix the contents of the bag to avoid foaming. Do not shake.

prepared product.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Method of administration

The infusion line for premedication can be used for IMDYLLTRA. An infusion line flush should be conducted between administering concomitant medicinal products and IMDYLLTRA.

Administer the entire contents of tarlatamab as an intravenous infusion over 1 hour at a constant flow rate using an infusion pump. The pump should be programmable, lockable, non-elastomeric, and have an alarm.

The infusion line is primed with sodium chloride 9 mg/mL (0.9%) solution for injection OR final prepared tarlatamab.

IMDYLLTRA should be infused over 1 hour at an infusion rate of 250 mL/hour.

Upon completion of the IMDYLLTRA infusion, the intravenous infusion line should be flushed over 3-5 minutes using sodium chloride 9 mg/mL (0.9%) solution for injection.

Storage conditions and shelf life

Unopened vial

4 years.

Diluted solution for intravenous infusion (infusion bag)

Chemical and physical in-use stability has been demonstrated for 28 days at 2°C to 8°C and 8 hours at 20°C to 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless the method of reconstitution and dilution has taken place in controlled and validated aseptic conditions.

The storage time includes total time permitted from point of reconstitution of first vial to the end of administration. After removal from refrigeration, allow the infusion bag to reach room temperature and complete administration of the diluted IMDYLLTRA infusion solution within the allowable room temperature storage time (including infusion time). If the prepared tarlatamab infusion bag is not administered within the time frames and temperatures indicated, it must be discarded; it should not be refrigerated again.

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.