Elzonris Special Precautions

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.
Capillary leak syndrome: Capillary leak syndrome (CLS), including life-threatening and fatal cases have been reported with most events occurring during the first five days of the first cycle of treatment. The most frequent signs and symptoms of CLS included weight increased, hypoalbuminemia and hypotension. The incidence of weight increased, hypoalbuminemia, hypotension, and blood alkaline phosphatase increased are all higher among patients who experienced CLS compared to patients that did not experience CLS. Renal failure and acute kidney injury have been reported in two patients with BPDCN and in one patient with AML secondary to CLS (see Adverse Reactions).
Before initiating therapy, ensure that the patient has adequate cardiac function and serum albumin ≥ 3.2 g/dL. During treatment, regularly monitor serum albumin levels prior to the initiation of each dose, or more often as clinically indicated. Additionally, assess patients for other signs/symptoms of CLS including weight gain, new onset or worsening oedema, including pulmonary oedema, and hypotension including haemodynamic instability (see Table 4 under Dosage & Administration).
Patients should be made aware of identifying CLS symptoms and when to seek immediate medical attention. Intravenous albumin supplementation and dosing interruptions may be required (see Dosage & Administration).
Hypersensitivity reactions: Severe hypersensitivity reactions have been reported with ELZONRIS. Commonly reported reactions include rash (generalised/maculo-papular); wheezing; pruritus; angioedema; swelling face; and flushing (see Adverse Reactions). Monitor patients for hypersensitivity reactions during treatment. Depending on the severity and the required interventions, temporarily withhold treatment and resume after symptoms have resolved (see Dosage & Administration).
Haematological abnormalities: Thrombocytopenia and neutropenia have been reported in patients treated with ELZONRIS monotherapy (see Adverse Reactions). The majority of events were reported in cycle 1 and cycle 2 of treatment, were not dose-limiting and did not recur in subsequent cycles. Patients should be routinely monitored and treated as clinically indicated.
Tumour lysis syndrome: ELZONRIS can cause tumour lysis syndrome (TLS), which may be fatal as a result of its rapid anti-tumour activity (see Adverse Reactions).
Identify TLS based on clinical presentation and symptoms, including acute renal failure, hyperkalaemia, hypocalcaemia, hyperuricaemia, or hyperphosphataemia from tumour lysis. Patients considered at high risk for TLS due to high tumour burden should be managed as clinically indicated, including correction of electrolyte abnormalities, monitoring of renal function and fluid balance, and administration of supportive care.
Hepatotoxicity: Treatment with ELZONRIS has been associated with elevations in liver enzymes (see Adverse Reactions). Acute hepatic failure and liver encephalopathy has been reported in a patient treated with ELZONRIS at a higher dose (16 mcg/kg). During treatment, regularly monitor ALT and AST levels prior to the initiation of each dose. Temporarily withhold treatment if transaminases rise to greater than 5 times the upper limit of normal and resume treatment when transaminase elevations are ≤ 2.5 times the upper limit of normal (see Dosage & Administration).
Choroid plexus lesions: Choroid plexitis was identified during non-clinical studies (see Pharmacology: Toxicology: Preclinical safety data under Actions). While not observed in clinical studies, if clinical symptoms or signs suggestive of central nervous system (CNS) damage occur, full clinical and neuro-imaging examination, including fundoscopy and brain magnetic resonance imaging, is recommended.
CNS-involved BPDCN: The passage of tagraxofusp through the blood brain barrier is unknown. Other treatment alternatives should be considered if CNS disease is present.
Hereditary fructose intolerence: Patients with hereditary fructose intolerance (HFI) must not be given this medicinal product unless strictly necessary.
A detailed history with regard to HFI symptoms has to be taken of each patient prior to being given this medicinal product.
Sodium sensitivity: This medicinal product contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially 'sodium-free'.
Effects on ability to drive and use machines: ELZONRIS has no or negligible influence on the ability to drive or use machines.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.