Safety Profile
There are common side effects that could occur with EMFLAZA. In a study of safety, the listed effects happened at a rate greater than 5%.
Common side effects with emflaza% of patients taking deflazacort 0.9 mg/kg/day at 12 weeks
- Facial puffiness or Cushingoid appearance 33%
- Frequent daytime urination 12%
- Common cold 10%
- Abdominal discomfort 6%
- Weight increased 20%
- Upper respiratory tract infection 12%
- Irritability 8%
- Increased appetite 14%
- Unwanted hair growth 10%
- Runny nose 8%
- Cough 12%
- Central obesity 10%
- Skin redness 8%
Please seek treatment immediately and tell your son's healthcare provider if your child has any of these symptoms or any other side effects.
Consider his behavior and weight—here, now, and tomorrow
The deflazacort molecule is different from other corticosteroids and was developed to provide a more tolerable treatment option.
In a 52-week clinical trial of 196 boys aged 5 to 15 years with DMD, the effectiveness and safety of EMFLAZA were compared with prednisone. In comparing adverse events between deflazacort
0.9 mg/kg/day and prednisone 0.75 mg/kg/day, the following was found:
- Fewer boys taking deflazacort experienced abnormal behavior compared to those taking prednisone
- Deflazacort: 8.8% (n=6/68); prednisone: 14.3% (n=9/63)
- Boys taking deflazacort experienced less weight gain compared to those taking prednisone
- Deflazacort: 27.9% (n=19/68); prednisone: 34.9% (n=22/63)
- More boys taking deflazacort experienced cataracts compared to those taking prednisone (4.4% vs 1.6%)
- No cataracts were considered serious events