Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
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60941 | 5830 |
Related information
Dosage
See prescribing information for full details
Indications
CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults.
Contra-Indications
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions
Capillary Leak Syndrome
Capillary leak syndrome (CLS), including life-threatening and fatal cases, has been reported. The median time to onset was 4 days (range – 1 to 46 days), and all but 5 patients experienced an event in Cycle 1.
Before initiating therapy patient has adequate cardiac function and serum albumin is greater than or equal to 3.2 g/dL. During treatment with the this medical product, monitor serum albumin levels prior to the initiation of each dose and as indicated clinically thereafter, and assess patients for other signs or symptoms of CLS, including weight gain, new onset or worsening edema, including pulmonary edema, hypotension or hemodynamic instability.
Hypersensitivity Reactions
In patients receiving tagraxofusp in clinical trials, hypersensitivity reactions were reported in 43% (53/122) of patients treated with tagraxofusp and were Grade ≥ 3 in 7% (9/122). Manifestations of hypersensitivity reported in ≥ 5% of patients include rash, pruritus, and stomatitis. Monitor patients for hypersensitivity reactions during treatment. Interrupt the infusion and provide supportive care as needed if a hypersensitivity reaction occurs. In case of severe or life-threatening hypersensitivity reactions, discontinue this medical product permanently.
Hepatotoxicity
Treatment with this medical product was associated with elevations in liver enzymes. In patients receiving tagraxofusp in clinical trials, elevations in ALT occurred in 79% (96/122) and elevations in AST occurred in 76% (93/122). Grade 3 ALT elevations were reported in 26% (32/122) of patients. Grade 3 AST elevations were reported in 30% (36/122) and Grade 4 AST elevations were reported in 3% (4/122) of patients. Elevated liver enzymes occurred in the majority of patients in Cycle 1 and were reversible following dose interruption. Monitor alanine aminotransferase (ALT) and aspartate aminotransferase (AST) prior to each infusion. Withhold temporarily if the transaminases rise to greater than 5 times the upper limit of normal and resume treatment upon normalization or when resolved.
Tumour Lysis Syndrome
Tagraxofusp can cause tumour lysis syndrome (TLS), which may be fatal as a result of its rapid antitumour activity. 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.
Side Effects
Four (3%) patients (4/122) had fatal adverse reactions, all of which were related to capillary leak syndrome. Overall, 8% (10/122) of patients discontinued treatment with tagraxofusp due to an adverse reaction; the most common adverse reactions resulting in treatment discontinuation were hepatic toxicities, hypoalbuminemia and CLS (2% each). See prescribing information for full details.
Drug interactions
No drug-drug interaction studies have been conducted
Pregnancy and Lactation
Pregnancy: Based on its mechanism of action, tagraxofusp has the potential for adverse effects on embryo-fetal development. There are no available data on tagraxofusp use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. Conduct pregnancy testing in females of reproductive potential within 7 days prior to initiating treatment. Advise females to use acceptable contraceptive methods during treatment and for 1 week after the last dose.
Lactation: No data are available regarding the presence of tagraxofusp in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children from tagraxofusp, breast feeding is not recommended during treatment and for 1 week after the
last dose.
Important notes
Store and transport frozen (-20 °C ±5 °C).