Danyelza

Have resuscitative medications and equipment available. Risk of serious infusion-related reactions. Monitor closely during and for at least 2 hours after completion of each infusion; reduce infusion rate, interrupt, or permanently discontinue based on severity; treat appropriately. Risk of severe neurotoxicity. Risk of severe hypotension in patients with pre-existing cardiac disease. Monitor for myocarditis esp. in adolescent patients during treatment; withhold, reduce dose, or permanently discontinue based on severity. Permanently discontinue if Grade 3 neuropathic pain unresponsive to maximum supportive measures, all Grades of RPLS, all Grades of transverse myelitis, Grade ≥2 motor neuropathy, Grade 3/4 sensory neuropathy, neurological eye disorders (subtotal or total vision loss), Grade 4 myocarditis, prolonged urinary retention following discontinuation of opioids, or all Grades of orthostatic hypotension (if unresolved within 1 week of withholding) develop. Uncontrolled hypertension: do not initiate. Monitor BP during and at least daily on Days 1–8 of each cycle; evaluate for complications (including RPLS); interrupt infusion, resume at a reduced rate, or permanently discontinue based on the severity. Monitor postural BP prior to initiating and as clinically indicated in patients with symptoms of orthostatic hypotension; withhold, reduce dose, or permanently discontinue based on severity. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 2 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 months after the last dose).