EMFLAZA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for EMFLAZA (EMFLAZA).
Agonist at glucocorticoid receptors, modulating gene expression to suppress inflammation and immune response.
| Metabolism | Primarily hepatic via CYP3A4 to active metabolite 6β-hydroxy-deflazacort. |
| Excretion | Renal excretion of inactive metabolites; less than 5% excreted as unchanged drug in urine. Biliary/fecal elimination accounts for <1%. |
| Half-life | 6.2 hours (range 4.5–8.1 h) in healthy adults; prolonged in hepatic impairment. |
| Protein binding | Approximately 85–90% bound to albumin and alpha-1-acid glycoprotein. |
| Volume of Distribution | Vd ~0.6 L/kg; distributes widely into tissues, including skeletal muscle. |
| Bioavailability | Oral bioavailability is approximately 30% (range 20–40%) due to first-pass metabolism; absolute bioavailability is 30%. |
| Onset of Action | Oral: ~1–2 hours for initial anti-inflammatory effect; maximal effect by 4–8 hours. |
| Duration of Action | Duration of anti-inflammatory effects is 24–36 hours after a single dose; therapeutic effects for Duchenne muscular dystrophy persist for 24 hours with once-daily dosing. |
0.6 mg/kg orally once daily (maximum 60 mg/day); titrate to lowest effective dose based on clinical response.
| Dosage form | SUSPENSION |
| Renal impairment | No dose adjustment required for renal impairment; has not been studied in ESRD. |
| Liver impairment | For Child-Pugh class A or B, reduce dose by 50%; for Child-Pugh class C, contraindicated. |
| Pediatric use | Approved for Duchenne muscular dystrophy in patients aged 2 years and older: 0.6 mg/kg orally once daily (maximum 60 mg/day). |
| Geriatric use | No specific dose adjustments; use caution due to increased risk of adverse effects (e.g., osteoporosis, infections). |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for EMFLAZA (EMFLAZA).
| Breastfeeding | Deflazacort is excreted into breast milk in small amounts. The M/P ratio is unknown. Use with caution in lactating women, considering the potential for adrenal suppression in the infant. Short-term use is likely compatible, but long-term high-dose therapy should be avoided. |
| Teratogenic Risk | EMFLAZA (deflazacort) is a corticosteroid. Corticosteroids are associated with an increased risk of orofacial clefts when used in the first trimester. In the second and third trimesters, prolonged use may cause fetal adrenal suppression, intrauterine growth restriction, and premature birth. Increased maternal blood pressure and glucose levels may also affect the fetus. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to deflazacort or any component","Systemic fungal infections"]
| Precautions | ["Increased risk of infection","Adrenal insufficiency","Cushing's syndrome","Osteoporosis","Gastrointestinal perforation","Behavioral and mood disturbances","Immunosuppression"] |
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| Fetal Monitoring | Monitor maternal blood glucose, blood pressure, and signs of infection. For the fetus, consider growth ultrasounds every 4-6 weeks during prolonged therapy. Assess for adrenal insufficiency in the newborn if used in the late third trimester. |
| Fertility Effects | Corticosteroids like deflazacort may alter menstrual cycles and reduce sperm motility or count in males, but effects on fertility are generally reversible upon discontinuation. |