Eteplirsen Dosage

Medically reviewed by Drugs.com. Last updated on Nov 20, 2023.

Applies to the following strengths: 50 mg/mL

Usual Adult Dose for Muscular Dystrophy

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

Comments:

Use a 0.2 micron in-line filter during infusion.
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:

Use a 0.2 micron in-line filter during infusion.
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:

Determine drug dosage based on patient's weight.
Administer once weekly as an IV infusion over 35 to 60 minutes.
A topical anesthetic cream may be applied to the infusion site prior to administration.
Flush IV line with 0.9% Sodium Chloride Injection before and after infusion; an in-line 0.2-micron filter should be used.

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 be slightly opalescent.
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.

Storage requirements:

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

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.

Patient advice:

Symptoms of hypersensitivity, including bronchospasm, chest pain, cough, tachycardia, and urticaria may occur.
If signs and symptoms of hypersensitivity occur, seek immediate medical care.