Tarlatamab (Specialist drug)

Concomitant medicines on Day 1 and Day 8: dexamethasone 8 mg intravenously (or equivalent) within 1 hour prior to the infusion, and 1 litre of normal saline intravenously immediately after completion of the infusion (per standard-of-care guidelines). Ensure patients are well hydrated before administration. Monitoring: during the infusion and for at least 16 hours after the first infusion (Day 1); 6-8 hours post infusion on Day 8; 2-4 hours post infusion at subsequent infusions at the healthcare professional's discretion. On Days 1 and 8 patients should remain within 1 hour of an appropriate healthcare setting for 24 hours from each infusion, accompanied by a caregiver, and both patient and caregiver should be informed of CRS and ICANS signs and symptoms before discharge. Restart after delay (SPC Table 6): last dose Day 1 1 mg — if 14 days or less give 10 mg and continue the planned schedule, if more than 14 days restart at 1 mg; last dose Day 8 10 mg — if 21 days or less give 10 mg, if more than 21 days restart at 1 mg; last dose Day 15 or later 10 mg — if 28 days or less give 10 mg, if more than 28 days restart at 1 mg. CRS (Table 2), ICANS (Table 3) and cytopenia/hepatic/other adverse-reaction (Table 4) dose modifications apply. Elderly: no dose adjustment necessary. Hepatic impairment: no dose adjustment in mild impairment; not studied in moderate or severe. Paediatric: safety and efficacy in children aged 18 years and under have not yet been established (§4.2). Must be initiated and supervised by physicians experienced in small cell lung cancer, and administered only by a qualified healthcare professional with support to manage severe CRS and ICANS.