The safety profile of Acthar has been demonstrated over many years of clinical use.
Safety was reviewed in 331 infants with infantile spasms from 4 clinical studies.1,3,14
When dosed as recommended by the FDA at 75 U/m2 twice daily for 2 weeks, Acthar reduced the risk and severity of dose-related adverse events compared to 150 U/m2 once daily for 2 weeks.1,3,14
Incidence of Treatment-Emergent Adverse Events Occurring in ≥2% of Acthar Patients1
aAbove is a summary of adverse events specifically tabulated from source data derived from retrospective chart reviews and clinical trials in children under 2 years of age treated for IS. The number of patients in controlled trials at the recommended dose was too few to provide meaningful comparison to the control groups. Data represent patients who received the daily dose of 150 U/m2.
bSpecific infections that occurred at ≥2% were candidiasis, otitis media, pneumonia, and upper respiratory tract infections.
cIn the treatment of IS, other types of seizures/convulsions may occur because some patients with IS 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.
Download this convenient and easy-to-follow Injection Training Guide for caregivers of children with IS.
Download for your practice to complete.
From per-injection volume to number of vials, our calculator does it all.
H.P. Acthar® Gel (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.Contraindications