Section 16 · Monograph

Deflazacort

Reviewed Nov 2026FDA label
EmflazaCorticosteroid
Forms
Tab: 6, 18, 30, 36mg | Susp: 22.75mg/mL
Dose
About 0.9mg/kg once daily (DMD, age 2+); reduce dose with moderate/strong CYP3A4 inhibitors
MOA
Anti-inflammatory/immunosuppressive

Indications

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

Mechanism of Action

  • Glucocorticoid prodrug (active metabolite 21-desDFZ) with anti-inflammatory and immunosuppressive effects; exact mechanism in DMD is unknown

Full Dosing

Adult / usual

  • About 0.9mg/kg once daily (tablets: round up to the nearest achievable dose; oral suspension 22.75mg/mL)
  • With moderate or strong CYP3A4 inhibitors, give one-third of the usual dose; avoid strong CYP3A4 inducers
  • Taper gradually when discontinuing after more than a few days
  • Administer live vaccines at least 4-6 weeks before starting

Contraindications

  • Known hypersensitivity to deflazacort or its excipients

Drug Interactions

  • Grapefruit juice should be avoided
  • Moderate/strong CYP3A4 inhibitors and inducers require dose changes or avoidance
  • May prolong the effect of neuromuscular blockers

Adverse Effects

  • Weight gain, cushingoid features, increased appetite
  • Cataracts, growth retardation
  • Behavioral changes
  • Adrenal suppression
  • Infections
  • Hyperglycemia, bone loss and fractures

Monitoring Parameters

  • Growth, blood pressure, glucose, ophthalmic exam for cataracts, bone health
  • Signs of infection
  • Vaccination status

Pregnancy & Lactation

  • Limited data; weigh risks and benefits
  • Unknown whether present in milk

References

  1. EMFLAZA (deflazacort) Prescribing Information — FDA

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