Section 16 · Monograph

Vamorolone

Reviewed Nov 2026FDA label
AgamreeDissociative steroid
Forms
Oral susp: 40mg/mL
Dose
Weight-based once daily, approx 6mg/kg/day (DMD, age 2+)
MOA
Glucocorticoid/mineralocorticoid receptor modulation with reduced transactivation

Indications

  • Treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and olderFDA-labeled

Mechanism of Action

  • Dissociative steroid that binds glucocorticoid and mineralocorticoid receptors, retaining anti-inflammatory transrepression with reduced transactivation-related adverse effects

Full Dosing

Adult / usual

  • Weight-based oral suspension once daily with food (approximately 6mg/kg/day)
  • Taper when discontinuing; review vaccinations before starting

Hepatic

  • Confirm the exact weight-band dose and hepatic-impairment adjustments against the current prescribing information

Contraindications

  • Known hypersensitivity to vamorolone or its excipients

Drug Interactions

  • Strong CYP3A4 inhibitors and inducers may require dose adjustment or avoidance
  • Live vaccines should be timed appropriately

Adverse Effects

  • Cushingoid features, vomiting, weight gain
  • Psychiatric and behavioral changes
  • Adrenal suppression
  • Infection risk
  • Bone and growth effects (growth suppression was less than with prednisone in trials)

Monitoring Parameters

  • Growth, blood pressure, glucose, bone health
  • Behavior and mood
  • Adrenal suppression on withdrawal

Pregnancy & Lactation

  • Limited data; weigh risks and benefits

References

  1. AGAMREE (vamorolone) Prescribing Information — DailyMed (NIH) search

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