Elevidys (delandistrogene moxeparvovec-rokl)

Adult Dosing .

Dosage forms:  INJ

Special Note

[formulation clarification]

Info: nonproprietary name = delandistrogene moxeparvovec-rokl

Duchenne muscular dystrophy

[10-70 kg]

Dose: 1.33 x10^14 vector genomes/kg/dose IV x1; Info: for ambulatory or non-ambulatory pts w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ corticosteroid, see pkg insert for dose

[>70 kg]

Dose: 9.31 x10^15 vector genomes IV x1; Info: for ambulatory or non-ambulatory pts w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ corticosteroid, see pkg insert for dose

renal dosing

[not defined]

renal impairment: not defined

HD/PD: not defined

hepatic dosing

[see below]

hepatic impairment/chronic hepatic dz: not defined, caution advised; acute hepatic dz: avoid use

Peds Dosing .

Dosage forms:  INJ

Special Note

[formulation clarification]

Info: nonproprietary name = delandistrogene moxeparvovec-rokl

Duchenne muscular dystrophy

[4 yo and older, 10-70 kg]

Dose: 1.33 x10^14 vector genomes/kg/dose IV x1; Info: for ambulatory or non-ambulatory pts w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ corticosteroid, see pkg insert for dose

[4 yo and older, >70 kg]

Dose: 9.31 x10^15 vector genomes IV x1; Info: for ambulatory or non-ambulatory pts w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ corticosteroid, see pkg insert for dose

renal dosing

[not defined]

renal impairment: not defined

HD/PD: not defined

hepatic dosing

[see below]

hepatic impairment/chronic hepatic dz: not defined, caution advised; acute hepatic dz: avoid use