Elzonris Dosage/Direction for Use

ELZONRIS should be administered under the supervision of a physician experienced in the use of anti-cancer agents. Appropriate resuscitation equipment should be available.
Posology: The recommended dose is 12 mcg/kg tagraxofusp administered as an intravenous infusion over 15 minutes, once daily, on days 1-5 of a 21-day cycle. The dosing period may be extended for dose delays up to day 10 of the cycle. Treatment should be continued until disease progression or unacceptable toxicity (see Precautions).
First treatment cycle: The first cycle of ELZONRIS should be administered in the in-patient setting. Patients should be monitored for signs and symptoms of hypersensitivity or capillary leak syndrome (see Precautions) until at least 24 hours after the last infusion.
Subsequent treatment cycles: ELZONRIS can be administered in the in-patient setting or in a suitable out-patient ambulatory care setting that is equipped for intensive monitoring of patients with haematopoietic malignancies undergoing treatment.
Pre-medication: Patients should be pre-medicated with a H1-histamine antagonist (e.g. diphenhydramine hydrochloride), a H2-histamine antagonist, a corticosteroid (e.g. 50 mg intravenous methylprednisolone or equivalent) and paracetamol approximately 60 minutes prior to the start of infusion (see Precautions).
Dose adjustments: Vital signs should be monitored and albumin, transaminases, and creatinine checked prior to preparing each dose of ELZONRIS. See Table 3 for recommended dose modifications and Table 4 for capillary leak syndrome (CLS) management guidelines.
Vital signs should be monitored frequently during dosing. (See Tables 3 and 4.)

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Special populations: Renal impairment: No data are available for patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: No data are available for patients with hepatic impairment (see Pharmacology: Pharmacokinetics under Actions).
Elderly: No dose adjustment is required for patients over 65 years of age (see Pharmacology: Pharmacokinetics under Actions). Generally, safety was similar between elderly patients (≥ 65 years of age) and patients less than 65 years of age treated with ELZONRIS.
Paediatric population: The safety and efficacy of ELZONRIS in children and adolescents below 18 years have not been established (see Pharmacology: Pharmacodynamics under Actions).
No data are available.
Method of administration: ELZONRIS is for intravenous use.
The prepared dose of diluted ELZONRIS should be administered via an infusion syringe pump over 15 minutes. The total infusion time should be controlled using an infusion syringe pump to deliver the entire dose and the sodium chloride 9 mg/mL (0.9%) solution for injection within 15 minutes.
ELZONRIS must not be administered as an intravenous push or bolus. It should be administered through a dedicated intravenous line and it must not be mixed with other medicinal products (see Incompatibilities under Cautions for Usage).
Prior to infusion, venous access should be established and maintained with sodium chloride 9 mg/mL (0.9%) solution for injection.
For instructions on preparation and administration of the medicinal product, see Special precautions for disposal and other handling under Cautions for Usage.