Elzonris

Elzonris

Manufacturer:

Alcami Carolinas

Distributor:

Zuellig

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Tagraxofusp
Indications/Uses
Monotherapy for the 1st-line treatment of blastic plasmacytoid dendritic cell neoplasm in adults.
Dosage/Direction for Use
IV Administer 12 mcg/kg via infusion syringe pump over 15 min, once daily, on days 1-5 of a 21-day cycle. May extend up to day 10 of the cycle for dose delays. Continue treatment until disease progression or unacceptable toxicity.
Contraindications
Special Precautions
Must not be administered as IV push or bolus. Should be administered through a dedicated IV line & must not be mixed w/ other medicinal products. Risk of capillary leak syndrome (CLS); severe hypersensitivity reactions; thrombocytopenia & neutropenia; tumour lysis syndrome; elevations in liver enzymes. Monitor for signs & symptoms of hypersensitivity or CLS until at least 24 hr after the last infusion. Pre-medicate w/ H1-histamine antagonist (eg, diphenhydramine HCl), H2-histamine antagonist, corticosteroid (eg, 50 mg IV methylprednisolone or equiv) & paracetamol approx 60 min prior to start of infusion. Monitor vital signs prior to preparing each dose & frequently during dosing. Check albumin, transaminases, & creatinine prior to preparing each dose. Ensure adequate cardiac function & serum albumin ≥3.2 g/dL before initiating therapy. Temporarily w/hold treatment if transaminases rise to >5 times ULN & resume treatment when transaminase elevations are ≤2.5 times ULN. Full clinical & neuro-imaging exam, including fundoscopy & brain MRI, is recommended if clinical symptoms or signs suggestive of CNS damage occur. Consider other treatment alternatives if CNS disease is present. Must not be given to patients w/ hereditary fructose intolerance unless strictly necessary. Should not be used during pregnancy unless clinical condition of the woman requires treatment. Women of childbearing potential should obtain -ve pregnancy test w/in 7 days prior to initiation of therapy, & use effective contraception before the 1st dose & for at least 1 wk after the last dose. Breast-feeding should be discontinued during treatment & for at least 1 wk after the last dose. Safety & efficacy in childn & adolescents <18 yr have not been established.
Adverse Reactions
Hypoalbuminemia, increased transaminases, thrombocytopenia, nausea, fatigue, pyrexia; CLS.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01XX67 - tagraxofusp ; Belongs to the class of other antineoplastic agents. Used in the treatment of cancer.
Presentation/Packing
Form
Elzonris conc for soln for infusion 1,000 mcg/mL
Packing/Price
1's
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