Acthar side effects are clinically recognizable
Side effects are typically reversible and resolve once treatment is stopped
- Patients may need careful monitoring during treatment with Acthar and for a period following the discontinuation of therapy
- Side effects are similar to those seen with corticosteroids
- Prolonged use of Acthar may increase the risk of side effects
Acthar has a known adverse event profile
Safety data were evaluated from 4 clinical trials
- The safety profile of Acthar was established in 331 infants with IS from 4 clinical studies
Incidence of treatment-emergent adverse events occurring in ≥2% of Acthar patients who received the daily dose of 150 U/m2*
*Above is a summary of adverse reactions specifically tabulated from source data derived from retrospective chart reviews and clinical trials in children under 2 years of age treated for infantile spasms. The number of patients in controlled trials at the recommended dose was too few to provide meaningful comparison to the control groups. Data represents patients who received the daily dose of 150 U/m2.
†Specific infections that occurred at ≥2% were candidiasis, otitis media, pneumonia, and upper respiratory tract infections.
‡In the treatment of infantile spasms, other types of seizures/convulsions may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut syndrome). Additionally, the spasms sometimes mask other seizures and once the spasms resolve after treatment, the other seizures may become visible.