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Eteplirsen Dosage

Medically reviewed on November 30, 2018.

Applies to the following strengths: 50 mg/mL

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Muscular Dystrophy

30 mg/kg IV once a week as an IV infusion over 35 to 60 minutes

Comments:
-This drug is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients; a clinical benefit has not been established
-Continued approval may be contingent upon clinical benefit in confirmatory trials.

Use: 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

Usual Pediatric Dose for Muscular Dystrophy

30 mg/kg IV once a week as an IV infusion over 35 to 60 minutes

Comments:
-This drug is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients; a clinical benefit has not been established
-Continued approval may be contingent upon clinical benefit in confirmatory trials.

Use: 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

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:
-None

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-A topical anesthetic may be applied to the infusion site prior to administration
-Flush the IV line with 0.9% sodium chloride prior to and after the infusion.
-Infuse the solution over 35 to 60 minutes.

Missed dose: If a dose is missed, it may be administered as soon as possible

Preparation techniques:
-Must be diluted prior to administration
-Allow vials to warm to room temperature
-Mix contents of vials gently by inverting 2 or 3 times; do not shake
-Solution should be clear and colorless, it may have some opalescence
-Dilute in 0.9% Sodium Chloride for injection to make a total volume of 100 to 150 mL; infusion should be completed within 4 hours
-If necessary, diluted solution may be may be stored for up to 24 hours at 2C to 8C (36F to 46F); do not freeze

Storage requirements:
-Diluted solution may be stored for up to 24 hours at 2C to 8C (36F to 46F); do not freeze
-Prior to use: Store at 2C to 8C (36F to 46F); Protect from light, store in original carton until ready for use

IV compatibility:
-Other medications should not be mixed or infused concomitantly with this drug via the same IV line

General:
-If a hypersensitivity reaction occurs, consider slowing the infusion or interrupting therapy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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