The most frequently reported adverse reactions (≤10%) in infants treated with HEMANGEOL were:
- Sleep disorders
- Aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever
- The following adverse events were observed with an incidence of less than 1%:
- Cardiac disorders
- Decreased blood glucose
- Decreased heart beat
- Fewer than 2% of treated patients discontinued treatment due to adverse reactions
Compassionate Use Program
More than 600 infants received HEMANGEOL in a compassionate use program (CUP). Mean age at treatment initiation was 3.6 months. Mean dose of HEMANGEOL was 2.2 mg/kg/day and mean treatment duration was 7.1 months.
The adverse reactions reported in the CUP were similar to the adverse drug reactions observed during clinical trials but some were more severe.