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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.
*Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by thehealthcare provider, for at least 2 months following delandistrogene moxeparvovec-rokl infusion.
*Select patients for treatment with delandistrogene moxeparvovec-rokl with anti-AAVrh74 total binding antibody titers <1:400. An FDA-authorized test for the detection of anti-AAVrh74 total binding antibodies is not currentlyavailable. Currently available tests may vary in accuracy and design.
Avoid administration of delandistrogene moxeparvovec-rokl in patients with elevated anti-AAVrh74 total binding antibody titers (>=1:400).
*Due to the increased risk of serious systemic immune response, postpone delandistrogene moxeparvovec-rok in patientswith active or recent (within 4 weeks) infections.
*Assess liver function (clinical examination and laboratory testing including AST, ALT, GGT,albumin, aPTT, INR, and totalbilirubin).
*Recommended dosage in patients weighing 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 weighing 70 kg or greater: 9.31 x1015 vg total fixed dose.
*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.
*Assess liver function, platelet counts, and troponin-I levels post-administration of delandistrogene moxeparvovec-rokl.
*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, and instructions on how to manage infusion-related reactions.
*Delandistrogene moxeparvovec-rokl is for single-dose IV infusion only.
*Instruct patients to maintain proximity to an appropriate healthcare facility, as determined by thehealthcare provider, for at least 2 months following delandistrogene moxeparvovec-rokl infusion.
*Select patients for treatment with delandistrogene moxeparvovec-rokl with anti-AAVrh74 total binding antibody titers <1:400. An FDA-authorized test for the detection of anti-AAVrh74 total binding antibodies is not currentlyavailable. Currently available tests may vary in accuracy and design.
Avoid administration of delandistrogene moxeparvovec-rokl in patients with elevated anti-AAVrh74 total binding antibody titers (>=1:400).
*Due to the increased risk of serious systemic immune response, postpone delandistrogene moxeparvovec-rok in patientswith active or recent (within 4 weeks) infections.
*Assess liver function (clinical examination and laboratory testing including AST, ALT, GGT,albumin, aPTT, INR, and totalbilirubin).
*Recommended dosage in patients weighing 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 weighing 70 kg or greater: 9.31 x1015 vg total fixed dose.
*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.
*Assess liver function, platelet counts, and troponin-I levels post-administration of delandistrogene moxeparvovec-rokl.
*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, and instructions 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, including a deletion of anyportion or the entirety of these exons, in the DMD gene.
*Patients with any deletion in exon 8 and/or exon 9, including a deletion of anyportion or the entirety of these exons, 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 (incidence >=5%) were vomiting and nausea, liver injury, pyrexia, thrombocytopenia, and increased troponin-I.
Most common adverse reactions (incidence >=5%) were vomiting and nausea, liver injury, pyrexia, thrombocytopenia, and increased troponin-I.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Fever |
Drug-induced hepatitis Dyspnea Hepatic failure Myocarditis Myositis |
| Rare/Very Rare |
|---|
|
Acute occlusion of mesenteric vein Anaphylaxis Lower respiratory infection Upper respiratory infection |
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. The use ofdelandistrogene moxeparvovec-rokl in pediatric patients was supported by evidence from three adequate and well controlled clinicalstudies which included 144 pediatric patients 4 years of age and older.
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):
WARNING: Delandistrogene moxeparvovec may rarely cause very serious (possibly fatal) liver disease. Before treatment with this medication, tell the doctor if your child has liver disease. The doctor should do lab tests to monitor your child's liver function before and after your child receives treatment.
To decrease the risk of liver problems, the doctor may also direct your child to take another medication by mouth (a corticosteroid such as prednisone) before and after your child receives this medication. Get medical help right away if your child develops symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.
WARNING: Delandistrogene moxeparvovec may rarely cause very serious (possibly fatal) liver disease. Before treatment with this medication, tell the doctor if your child has liver disease. The doctor should do lab tests to monitor your child's liver function before and after your child receives treatment.
To decrease the risk of liver problems, the doctor may also direct your child to take another medication by mouth (a corticosteroid such as prednisone) before and after your child receives this medication. Get medical help right away if your child develops symptoms of liver disease, such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.
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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