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Exondys 51 Generic Name & Formulations
Legal Class
Rx
General Description
Eteplirsen 50mg/mL; per vial; soln for IV infusion after dilution; preservative-free.
Pharmacological Class
Antisense oligonucleotide.
How Supplied
Single-dose vial (2mL, 10mL)—1
Manufacturer
Generic Availability
NO
Exondys 51 Indications
Indications
Duchenne muscular dystrophy (DMD) in patients with a confirmed DMD gene mutation that is amenable to exon 51 skipping.
Exondys 51 Dosage and Administration
Adults and Children
May apply topical anesthetic cream to IV site prior to administration. Give by IV infusion over 35–60mins. 30mg/kg once weekly.
Exondys 51 Contraindications
Not Applicable
Exondys 51 Boxed Warnings
Not Applicable
Exondys 51 Warnings/Precautions
Warnings/Precautions
Treat appropriately and consider slowing the infusion or interrupting therapy if hypersensitivity reactions occur. Renal impairment. Pregnancy. Nursing mothers.
Exondys 51 Pharmacokinetics
See Literature
Exondys 51 Interactions
Interactions
Do not mix or infuse with other medications concomitantly via same IV access line.
Exondys 51 Adverse Reactions
Adverse Reactions
Balance disorder, vomiting, contact dermatitis; hypersensitivity reactions.
Exondys 51 Clinical Trials
See Literature
Exondys 51 Note
Not Applicable
Exondys 51 Patient Counseling
See Literature
