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Skysona
elivaldogene autotemcel
Black Box Warnings .
Hematologic Malignancy
including life-threatening myelodysplastic syndrome, acute myeloid leukemia have occurred; patients diagnosed 14mo-10y after administration; weigh risk/benefit and consider hematology consult before treatment start; monitor closely with CBC at least q3mo and assessments for evidence of clonal expansion or predominance 2x in 1st year, then annually; consider bone marrow evaluations as clinically indicated
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: INJ
Restricted Distribution in US
- [1-833-666-2583 or www.skysona.com for more info]
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses, prophylactic regimens, and dosing
cerebral adrenoleukodystrophy, male
- [4-17 yo]
- Dose: 5x10^6 CD34+ cells/kg/dose IV x1; Start: >48h after myeloablative and lymphodepleting conditioning; Info: for patients with early, active disease without human leukocyte antigen-matched donor for allogeneic HSCT; do not start myeloablative and lymphodepleting conditioning until confirming elivaldogene autotemcel infusion bag(s) at treatment facility and back-up collection of CD34+ cells available; consider premed with antiemetic, antipyretic, and/or antihistamine
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]