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Review
25 October 2024

Clinical assessment of the potential use of a novel single-dose prefilled injection device for the administration of Acthar Gel in children: a narrative review

Authors: Johanna Purcell https://orcid.org/0009-0001-5339-8927 and Sheila Elliott https://orcid.org/0009-0005-2994-5301 [email protected]Author Info & Affiliations
Volume 13, Number 12
https://doi.org/10.57264/cer-2024-0132
PDFFormats

Abstract

Acthar® Gel (repository corticotropin injection; Mallinckrodt Pharmaceuticals, NJ, USA) is indicated for the treatment of myriad inflammatory disorders and is currently administered manually via a vial and syringe. The administration of Acthar via a single-dose prefilled injector (SelfJect™) is intended to simplify its subcutaneous (SC) delivery. The purpose of this review was to determine whether SelfJect is suitable for use in pediatric patients through a literature assessment of various factors, including skin depth, needle length and gauge, dosage, force required for injection, and potential harms. Infants and young children, who commonly have skin-to-muscle distances less than the minimum depth of SelfJect administration, may have risk of unintentional intramuscular (IM) injection; however, an inadvertent IM injection poses no additional risk to children because of the bioequivalence between SC and IM administration of Acthar. The needle gauge of SelfJect is acceptable for pediatric patients and aligns with the Centers for Disease Control and Prevention recommendations for SC injections. The dosage delivered by SelfJect is only appropriate for children over 2 years of age. Although adolescents would likely be able to achieve the minimum force required to remove the protective cap and deliver a full dose of Acthar with SelfJect, an adult (18 years of age and older) should administer SelfJect to pediatric patients. In addition to the commonly reported postmarketing adverse events (AEs) from Acthar administration (e.g., asthenic conditions, fluid retention, insomnia, headache and increased blood glucose), injection site-related AEs common to injection devices may occur with SelfJect use. The risk of needlestick injury from SelfJect is mitigated by a needle guard. In summary, this review of injection device considerations demonstrates that SelfJect is appropriate for use in the pediatric population.

Shareable abstract

This narrative review found that a single-dose prefilled injector (SelfJect™) for administration of Acthar® Gel (repository corticotropin injection) is appropriate for use in pediatric patients if administered by an adult 18 years of age and older. #ActharGel #SelfJect

Plain language summary of a narrative review on the potential use of a novel injection device for Acthar Gel in children

What is this article about?

Acthar® Gel (repository corticotropin injection) may be prescribed for inflammatory diseases, such as rheumatoid arthritis and lupus. Acthar must be injected under the skin using a vial and syringe. A novel injection device (SelfJect™) has been developed to simplify Acthar injection. This review assessed if SelfJect may be used in pediatric patients (less than 18 years of age).

What were the results?

In infants and young children, Acthar may accidentally be injected too deeply into the muscle because of small distances from the skin to the underlying muscle. However, Acthar functions the same whether it is injected beneath the skin or into the muscle, and there is no risk for children if Acthar is injected too deeply. The size of the SelfJect needle is acceptable for pediatric patients and is in line with injection recommendations from the Centers for Disease Control and Prevention. The medication dosage delivered with SelfJect is only appropriate for children greater than 2 years of age. Although adolescents are likely strong enough to operate SelfJect, it is currently recommended that SelfJect injections be given to pediatric patients by adults 18 years of age and older. Side effects, such as pain, redness and swelling, may occur at the site of injection. A needle guard prevents inadvertently contacting the device needle.

What do the results of the study mean?

The novel SelfJect device for injection of Acthar is appropriate for use in pediatric patients if an adult operates the device.

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