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Elevidys (delandistrogene moxeparvovec-rokl)
delandistrogene moxeparvovec
Adult Dosing .
Dosage forms: INJ
Special Note
- [drug name 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 patients w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ oral corticosteroid, see pkg insert for dose and timing
- [>70 kg]
- Dose: 9.31 x10^15 vector genomes IV x1; Info: for ambulatory patients w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ oral corticosteroid, see pkg insert for dose and timing
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment/chronic hepatic disease: not defined, caution advised; acute hepatic disease: avoid use
Peds Dosing .
- Dosage forms: INJ
Special Note
- [drug name 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 patients w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ oral corticosteroid, see pkg insert for dose and timing
- [4 yo and older, >70 kg]
- Dose: 9.31 x10^15 vector genomes IV x1; Info: for ambulatory patients w/ confirmed mutation in DMD gene and anti-AAVrh74 total binding antibody titer <1:400; use w/ oral corticosteroid, see pkg insert for dose and timing
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- hepatic impairment/chronic hepatic disease: not defined, caution advised; acute hepatic disease: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- hepatic disease, acute
- anti-AAVrh74 total binding antibody titer >1:400
- DMD gene w/ exon 8-9 deletion
- caution: DMD gene w/ exon 1-7 deletion
- caution: DMD gene w/ exon 10-17 deletion
- caution: DMD gene w/ exon 59-71 deletion
- caution: hepatic impairment
- caution: hepatic disease, chronic
- caution: LVEF impairment
Drug Interactions .
Overview
delandistrogene moxeparvovec
gene therapy
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- hepatic injury, acute
- hepatic failure, acute
- infection, serious
- immune-mediated myositis
- infusion reaction, severe
- myocarditis
- anaphylaxis
Common Reactions
- vomiting
- nausea
- LFTs incr.
- fever
- thrombocytopenia
Safety/Monitoring .
Monitoring Parameters
LFTs at baseline, then qwk x3mo; Plt at baseline, then qwk x2wk; troponin-I at baseline, then qwk x1mo; signs/symptoms of infusion reaction during and for at least 3h after infusion
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human or animal data available
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for delandistrogene moxeparvovec: proteolytic degradation (protein capsid); CYP450: none
Excretion: for delandistrogene moxeparvovec: urine, feces; Half-life: 12h (serum), 40h (urine), 55h (feces), 60h (saliva)
Subclass: Muscular Dystrophies
Mechanism of Action
for delandistrogene moxeparvovec: recombinant adeno-associated viral vector delivers gene encoding a micro-dystrophin protein to target muscle cells
Formulary .
No Formulary Selected
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