SAFETY &
TOLERABILITY
TOLERABILITY
EMFLAZA® safety profile
EMFLAZA does have a risk of side effects. Please seek treatment immediately and tell your child's healthcare provider if your child has any of these symptoms or any other side effects.
| Common side effects with EMFLAZA | Deflazacort 0.9 mg/kg/day (n=51) % at 12 weeks | Placebo (n=50) % at 12 weeksa |
|---|---|---|
| Facial puffiness or Cushingoid appearance | 33% | 12% |
| Weight increased | 20% | 6% |
| Increased appetite | 14% | 2% |
| Cough | 12% | 10% |
| Frequent daytime urinatioan | 12% | 6% |
| Upper respiratory tract infection | 12% | 2% |
| Unwanted hair growth | 10% | 6% |
| Central obesity | 10% | 2% |
| Common cold | 10% | 4% |
| Irritability | 8% | 6% |
| Runny nose | 8% | 4% |
| Skin redness | 8% | 0% |
| Abdominal discomfort | 6% | 2% |
- At 12 weeks placebo patients were re-randomized to receive either EMFLAZA or an active comparator.
More time on treatment may mean more time experiencing results
In a clinical study, fewer patients taking deflazacort experienced side effects than patients taking prednisone.
Changes in behavior are common with corticosteroid therapy in boys with Duchenne and can often lead to treatment changes or modifications
- Boys taking deflazacort were less likely to experience psychiatric side effects such as abnormal behavior, aggression, irritability, and mood swings compared with those taking prednisone
Weight gain may negatively impact the ability to walk for children with Duchenne
- Boys taking deflazacort also gained less weight compared with those taking prednisone (5% increase in body weight vs 18%)
- More boys taking deflazacort experienced cataracts compared with those taking prednisone (4.4% vs 1.6%)