- Prime the intravenous access line with normal saline solution.
- Infuse the diluted EXONDYS 51 solution over 35 to 60 minutes via an in-line 0.2 micron filter. Administer the diluted EXONDYS 51 solution to patient at a rate of approximately 1.5-4.5 mL/min, depending on volume (100-150 mL) and infusion time.
- If a hypersensitivity reaction occurs, consider slowing the infusion or interrupting the EXONDYS 51 therapy.
- Do not mix other medications with EXONDYS 51 or infuse other medications concomitantly via the same intravenous access with EXONDYS 51.
- After completion of the infusion, flush the intravenous access line with sodium chloride 0.9% injection, USP, to allow the entire dose, including the contents of the intravenous access line, to be administered.
- In cases where EXONDYS 51 is administered into a venous access port, after administration of the drug and flushing with normal saline, the port may be flushed with heparin prior to de-access.
- Once you have completed the infusion, discard any unused product.
- If a dose of EXONDYS 51 is missed, it may be administered as soon as possible after the scheduled time.
- EXONDYS 51 has been infused at a treatment center (medical office, stand-alone infusion center, hospital) or at home.
- Based on physician, patient, and/or caregiver discretion, a port (implanted venous access device) may be considered for treatment administration.
- Application of a topical anesthetic cream to the infusion site prior to administration of EXONDYS may be considered.
SYMPTOMS OF HYPERSENSITIVITY.
Advise patients and/or caregivers that symptoms of hypersensitivity, including bronchospasm and hypotension, can occur with EXONDYS 51. Instruct them to seek immediate medical care should they experience signs and symptoms of hypersensitivity.
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EXONDYS 51 (eteplirsen) is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
Hypersensitivity reactions, including rash and urticaria, pyrexia, flushing, cough, dyspnea, bronchospasm, and hypotension, have occurred in patients who were treated with EXONDYS 51. If a hypersensitivity reaction occurs, institute appropriate medical treatment and consider slowing the infusion or interrupting the EXONDYS 51 therapy.
EXONDYS 51 [package insert]. Cambridge, MA: Sarepta Therapeutics Inc.
Data on file.
Infusion Nurses Society. Infusion Therapy Standards of Practice 2016, Online edition. Journal of Infusion Nursing. Available at: http://ins.tizrapublisher.com/hai13r/. Accessed June 1, 2018.