Mallinckrodt Pharmaceuticals, Bridgewater, NJ 08807, USA.
J Comp Eff Res. 2024 Dec;13(12):e240132. doi: 10.57264/cer-2024-0132. Epub 2024 Oct 25.
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.
阿特赫凝胶（储存促皮质素注射液；美国马利兰州诺克罗斯特制药公司）被批准用于治疗多种炎症性疾病，目前通过小瓶和注射器手动给药。通过单剂量预填充注射器（SelfJect™）给药旨在简化其皮下（SC）给药。本综述的目的是通过评估包括皮肤深度、针头长度和规格、剂量、注射所需的力以及潜在危害在内的各种因素，确定 SelfJect 是否适合儿科患者使用。婴儿和幼儿的皮肤-肌肉距离通常小于 SelfJect 给药的最小深度，可能存在意外肌内（IM）注射的风险；但是，由于阿特赫 SC 和 IM 给药的生物等效性，意外 IM 注射对儿童没有额外的风险。SelfJect 的针头规格适合儿科患者，符合疾病控制和预防中心对 SC 注射的建议。SelfJect 给药的剂量仅适用于 2 岁以上的儿童。尽管青少年可能能够达到去除保护帽并使用 SelfJect 给予完整剂量所需的最小力，但应让成年人（18 岁及以上）为儿科患者使用 SelfJect。除了阿特赫给药后常见的上市后不良事件（AE）（例如，虚弱状态、体液潴留、失眠、头痛和血糖升高）外，与注射装置相关的 AE 也可能与 SelfJect 的使用有关。使用 SelfJect 可减轻与注射部位相关的不良事件的风险。总的来说，对注射装置考虑因素的综述表明，SelfJect 适合儿科人群使用。
