Tagraxofusp Disease Interactions

Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported among patients treated with tagraxofusp. Common signs and symptoms (incidence = 20%) associated with CLS include hypoalbuminemia, edema, weight gain, and hypotension. Before initiating therapy with tagraxofusp, ensure that the patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment, monitor serum albumin levels prior to the initiation of each dose of tagraxofusp and as indicated clinically thereafter, and assess patients for any signs or symptoms of CLS.

Treatment with tagraxofusp was associated with elevations in liver enzymes in patients in clinical trials. Elevations in liver enzymes occurred in 88% of patients. Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion with tagraxofusp. Withhold treatment temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved. Additionally, severe hepatic impairment (total bilirubin >3 times ULN and any AST) on tagraxofusp pharmacokinetics is unknown. No clinically significant differences in the pharmacokinetics were observed in patients with mild or moderate hepatic impairment.

The effect of severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), on tagraxofusp pharmacokinetics is unknown. Caution is advised if used on these patients. No clinically significant differences in the pharmacokinetics were observed in patients with mild and moderate renal impairment.