Lenmeldy

Adult Dosing .

Adult dosing is currently unavailable or not applicable for this drug.

Peds Dosing .

Dosage forms:  INJ

Restricted Distribution in US

[1-833-672-4278 or www.lenmeldy.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

metachromatic leukodystrophy

[pre-symptomatic late infantile dz]

Dose: 4.2 x10^6 CD34+ cells/kg/dose IV x1; Start: >24h after myeloablative conditioning w/ busulfan; Max: 30 x10^6 CD34+ cells/kg/dose; Info: do not start myeloablative conditioning until confirming atidarsagene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available

[pre-symptomatic early juvenile dz]

Dose: 9 x10^6 CD34+ cells/kg/dose IV x1; Start: >24h after myeloablative conditioning w/ busulfan; Max: 30 x10^6 CD34+ cells/kg/dose; Info: do not start myeloablative conditioning until confirming atidarsagene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available

[early symptomatic early juvenile dz]

Dose: 6.6 x10^6 CD34+ cells/kg/dose IV x1; Start: >24h after myeloablative conditioning w/ busulfan; Max: 30 x10^6 CD34+ cells/kg/dose; Info: do not start myeloablative conditioning until confirming atidarsagene autotemcel infusion bag(s) at tx facility and back-up collection of CD34+ cells available

renal dosing

[not defined]

renal impairment: not defined

HD/PD: not defined

hepatic dosing

[not defined]