STORAGE AND HANDLING.1
Once you receive EXONDYS 51 at your facility, be sure to store it according to proper procedures.
Store EXONDYS 51 at 2°C to 8°C (36°F to 46°F)
Protect from light and store in the original carton until ready for use
Do not freeze
To infuse EXONDYS 51, you will need:
EXONDYS 51 10 mL or 2 mL single-dose vials
0.9% sodium chloride injection, USP, (normal saline solution) infusion bag (100-150 mL)
A syringe fitted with a 21-gauge or smaller non-coring needle
PREPARING THE PUMP.
Prepare the infusion pump and tubing as per the normal operating instructions for the make/model being used for the patient’s infusion.
PREPARING EXONDYS 51.1
Using aseptic technique, prepare EXONDYS 51 according to these steps:
Assess the patient’s IV or port for patency prior to removing any vials from the refrigerator. If IV access is adequate, remove the appropriate number of vials from the refrigerator and allow them to warm to room temperature. Do not microwave vials.
Once at room temperature, mix the contents of each vial by gently inverting 2 or 3 times. Do not shake. Visually inspect each vial of EXONDYS 51. EXONDYS 51 is a clear, colorless solution that may have some opalescence. Do not use the solution in vials if discolored or particulate matter is present and report the issue to Sarepta at 1-888-SAREPTA (1-888-727-3782).
With a syringe fitted with a 21-gauge or smaller non-coring needle, withdraw the calculated volume of EXONDYS 51 from the appropriate number of vials. In order to avoid damage to the rubber stopper, the same needle should not be used to puncture more than 4 vials.
Before adding the calculated volume of EXONDYS 51 to the saline bag, remove an equal volume of normal saline solution from the bag. Next, inject the bag with the syringe containing the calculated patient dose of EXONDYS 51. Gently invert infusion bag to ensure equal distribution of product. Avoid agitation during preparation. Contents can be mixed through 2-3 gentle inversions. Do not shake. Visually inspect the diluted solution for particulates. EXONDYS 51 contains no preservatives and should be administered immediately after a dilution. Complete infusion within 4 hours of dilution. If immediate use is not possible, the diluted product may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F).
Application of a topical anesthetic cream to the infusion site prior to administration of EXONDYS 51 may be considered.
EXONDYS 51 is administered via intravenous infusion. Flush the patient’s intravenous access with sodium chloride 0.9% injection, USP, prior to and after infusion.
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EXONDYS 51 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. A clinical benefit of EXONDYS 51 has not been established. 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; October 2018.