Talquetamab (Specialist drug)

Step-up doses may be given 2 to 4 days after the previous dose, and up to 7 days after, to allow resolution of adverse reactions. Patients who attain an adequate clinical response on 0.4 mg/kg weekly, confirmed in at least two consecutive disease assessments, may be considered for switch to 0.8 mg/kg biweekly. Pre-treatment 1 to 3 hours before EACH step-up dose: corticosteroid (oral or IV dexamethasone 16 mg or equivalent), antihistamine (oral or IV diphenhydramine 50 mg or equivalent), antipyretic (oral or IV paracetamol 650 mg to 1000 mg or equivalent); also before repeated step-up doses after delay and in patients who experienced CRS. Patients should remain within proximity of a healthcare facility and be monitored for 48 hours after every step-up-phase dose for CRS and ICANS. Consider infection prophylaxis per local guidelines before starting. Duration: treat until disease progression or unacceptable toxicity. Detailed dose-delay restart rules (SPC Table 2), CRS/ICANS management (Tables 3-5) and other dose modifications (Table 6) apply. Oral toxicity including weight loss not responding to supportive care: interrupt, then consider restarting on a modified schedule (0.4 mg/kg weekly to 0.4 mg/kg every 2 weeks; 0.8 mg/kg every 2 weeks to 0.8 mg/kg every 4 weeks). Elderly: no dose adjustment. Hepatic impairment: no dose adjustment in mild impairment; limited or no data in moderate and severe. Paediatric: there is no relevant use of talquetamab in the paediatric population in the treatment of multiple myeloma (§4.2). Must be initiated and supervised by physicians experienced in multiple myeloma, with personnel and equipment to manage severe CRS and neurologic toxicity/ICANS.