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Drug overview for ELEVIDYS (delandistrogene moxeparvovec-rokl):
Generic name: delandistrogene moxeparvovec-rokl
Drug class:
Therapeutic class: Locomotor System
Delandistrogene moxeparvovec-rokl is an adeno-associated virus vector-based gene therapy.
No enhanced Uses information available for this drug.
Generic name: delandistrogene moxeparvovec-rokl
Drug class:
Therapeutic class: Locomotor System
Delandistrogene moxeparvovec-rokl is an adeno-associated virus vector-based gene therapy.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ELEVIDYS (delandistrogene moxeparvovec-rokl) have been approved by the FDA:
Indications:
Duchenne muscular dystrophy
Professional Synonyms:
Duchenne MD
Pseudohypertrophic muscular dystrophy
Indications:
Duchenne muscular dystrophy
Professional Synonyms:
Duchenne MD
Pseudohypertrophic muscular dystrophy
The following dosing information is available for ELEVIDYS (delandistrogene moxeparvovec-rokl):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Delandistrogene moxeparvovec-rokl is for single-dose IV infusion only.
*Select patients for treatment with delandistrogene moxeparvovec-rokl with anti-AAVrh74 total binding antibody titers <1:400. Measure baseline anti-AAVrh74 antibody titers using a Total Binding Antibody enzyme-linked immunosorbent assay (ELISA). Administration of delandistrogene moxeparvovec-rokl is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers (>=1:400).
*Recommended dosage in patients 10 to 70 kg: 1.33 x1014 vector genomes (vg) per kg (vg/kg) of body weight (or 10 mL/kg body weight).
*Recommended dosage in patients 70 kg or greater: 9.31 x1015 vg total fixed dose.
*There are limited safety data available in non-ambulatory patients weighing 70 kg or greater, who received the maximum dose of delandistrogene moxeparvovec-rokl, 9.31 x 1015 vg, in clinical trials.
*Calculate the dose as follows: dose (in mL) = patient body weight (rounded to the nearest kg) x 10. The multiplication factor 10 represents the per kg dose (1.33 x 1014 vg/kg) divided by the amount of vector genome copies per mL of the suspension (1.33 x 1013 vg/mL). Number of vials needed = dose (in mL) divided by 10 (round to the nearest number of vials).
*Administer as an IV infusion using a syringe infusion pump with an in-line 0.2-micron filter over approximately 1-2 hours through a peripheral limb vein. Infuse at a rate of less than 10 mL/kg/hour.
Do not administer as an IV push and do not infuse into the same IV access line with any other product. Consider application of a topical anesthetic to the infusion site prior to administration of IV insertion.
*Administer in a setting where treatment for infusion-related reactions is immediately available.
*Postpone treatment in patients with concurrent infections until the infection has resolved.
*Assess liver function, platelet counts, and troponin-I levels before delandistrogene moxeparvovec-rokl infusion.
*To reduce the risk of an immune response, administer a corticosteroid regimen one day prior to infusion and continue for a minimum of 60 days after the infusion. Corticosteroid dose modifications are recommended for patients with liver function abnormalities.
*See full prescribing information for additional information on preparation and administration, andinstructions on how to manage infusion-related reactions.
Delandistrogene moxeparvovec-rokl is for single-dose IV infusion only.
*Select patients for treatment with delandistrogene moxeparvovec-rokl with anti-AAVrh74 total binding antibody titers <1:400. Measure baseline anti-AAVrh74 antibody titers using a Total Binding Antibody enzyme-linked immunosorbent assay (ELISA). Administration of delandistrogene moxeparvovec-rokl is not recommended in patients with elevated anti-AAVrh74 total binding antibody titers (>=1:400).
*Recommended dosage in patients 10 to 70 kg: 1.33 x1014 vector genomes (vg) per kg (vg/kg) of body weight (or 10 mL/kg body weight).
*Recommended dosage in patients 70 kg or greater: 9.31 x1015 vg total fixed dose.
*There are limited safety data available in non-ambulatory patients weighing 70 kg or greater, who received the maximum dose of delandistrogene moxeparvovec-rokl, 9.31 x 1015 vg, in clinical trials.
*Calculate the dose as follows: dose (in mL) = patient body weight (rounded to the nearest kg) x 10. The multiplication factor 10 represents the per kg dose (1.33 x 1014 vg/kg) divided by the amount of vector genome copies per mL of the suspension (1.33 x 1013 vg/mL). Number of vials needed = dose (in mL) divided by 10 (round to the nearest number of vials).
*Administer as an IV infusion using a syringe infusion pump with an in-line 0.2-micron filter over approximately 1-2 hours through a peripheral limb vein. Infuse at a rate of less than 10 mL/kg/hour.
Do not administer as an IV push and do not infuse into the same IV access line with any other product. Consider application of a topical anesthetic to the infusion site prior to administration of IV insertion.
*Administer in a setting where treatment for infusion-related reactions is immediately available.
*Postpone treatment in patients with concurrent infections until the infection has resolved.
*Assess liver function, platelet counts, and troponin-I levels before delandistrogene moxeparvovec-rokl infusion.
*To reduce the risk of an immune response, administer a corticosteroid regimen one day prior to infusion and continue for a minimum of 60 days after the infusion. Corticosteroid dose modifications are recommended for patients with liver function abnormalities.
*See full prescribing information for additional information on preparation and administration, andinstructions on how to manage infusion-related reactions.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ELEVIDYS (delandistrogene moxeparvovec-rokl):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ELEVIDYS (delandistrogene moxeparvovec-rokl):
Drug contraindication overview.
*Patients with any deletion in exon 8 and/or exon 9 in the DMD gene.
*Patients with any deletion in exon 8 and/or exon 9 in the DMD gene.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disease of liver |
| Infection |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Left ventricular failure |
The following adverse reaction information is available for ELEVIDYS (delandistrogene moxeparvovec-rokl):
Adverse reaction overview.
Most common adverse reactions across studies (incidence >=5%) were vomiting and nausea, liver injury, pyrexia, and thrombocytopenia.
Most common adverse reactions across studies (incidence >=5%) were vomiting and nausea, liver injury, pyrexia, and thrombocytopenia.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Fever |
Dyspnea Hepatic failure Myocarditis Myositis |
| Rare/Very Rare |
|---|
|
Anaphylaxis |
There are 8 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abnormal hepatic function tests Nausea Thrombocytopenic disorder Vomiting |
Dysphagia Myalgia Voice change |
| Rare/Very Rare |
|---|
|
Hypersensitivity drug reaction |
The following precautions are available for ELEVIDYS (delandistrogene moxeparvovec-rokl):
The safety and effectiveness of delandistrogene moxeparvovec-rokl for the treatment of Duchenne muscular dystrophy have been established in pediatric patients at least 4 years of age with a confirmed mutation in the DMD gene.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Delandistrogene moxeparvovec-rokl is not intended for use in pregnant women. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There is no information available on the presence of delandistrogene moxeparvovec-rokl in human milk, the effects on the breastfed infant, or the effects on milk production.
The safety and efficacy of delandistrogene moxeparvovec-rokl in geriatric patients with DMD have not been studied.
The following prioritized warning is available for ELEVIDYS (delandistrogene moxeparvovec-rokl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ELEVIDYS (delandistrogene moxeparvovec-rokl)'s list of indications:
| Duchenne muscular dystrophy | |
| G71.01 | Duchenne or becker muscular dystrophy |
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