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.

IF 1.9 4区 医学 Q3 HEALTH CARE SCIENCES & SERVICES Journal of comparative effectiveness research Pub Date : 2024-12-01 Epub Date: 2024-10-25 DOI:10.57264/cer-2024-0132
Johanna Purcell, Sheila Elliott
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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.

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新型单剂量预充式注射装置用于儿童注射 Acthar 凝胶的潜在用途临床评估:综述。
Acthar® Gel(repository corticotropin injection;Mallinckrodt Pharmaceuticals,NJ,USA)适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。通过单剂量预充式注射器(SelfJect™)给药 Acthar 的目的是简化皮下 (SC) 给药。本综述旨在通过对各种因素(包括皮肤深度、针头长度和规格、剂量、注射所需力量以及潜在危害)进行文献评估,确定 SelfJect 是否适合用于儿童患者。婴幼儿的皮肤到肌肉的距离通常小于 SelfJect 给药的最小深度,因此可能存在意外肌肉注射 (IM) 的风险;不过,由于 Acthar 皮下注射和 IM 给药之间具有生物等效性,因此意外 IM 注射不会给儿童带来额外风险。SelfJect 的针头规格是儿童患者可以接受的,并且符合美国疾病控制和预防中心对 SC 注射的建议。SelfJect 给药剂量仅适合 2 岁以上儿童。尽管青少年很可能能够达到取下保护帽和使用 SelfJect 给出全剂量 Acthar 所需的最小力量,但仍应由成人(18 岁及以上)为儿科患者注射 SelfJect。除了上市后常见的 Acthar 给药不良事件 (AE)(如虚弱、体液潴留、失眠、头痛和血糖升高)外,使用 SelfJect 还可能发生注射装置常见的注射部位相关不良事件。SelfJect 的针刺伤害风险可通过护针器得到缓解。总之,对注射装置注意事项的回顾表明,SelfJect 适合用于儿童群体。
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来源期刊
Journal of comparative effectiveness research
Journal of comparative effectiveness research HEALTH CARE SCIENCES & SERVICES-
CiteScore
3.50
自引率
9.50%
发文量
121
期刊介绍: Journal of Comparative Effectiveness Research provides a rapid-publication platform for debate, and for the presentation of new findings and research methodologies. Through rigorous evaluation and comprehensive coverage, the Journal of Comparative Effectiveness Research provides stakeholders (including patients, clinicians, healthcare purchasers, and health policy makers) with the key data and opinions to make informed and specific decisions on clinical practice.
期刊最新文献
Advancing the role of real-world evidence in comparative effectiveness research. 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. A novel injection device to administer repository corticotropin injection for inflammatory disease treatment: findings from a market research study. Healthcare costs and resource utilization of patients with chronic post-traumatic stress disorder: a retrospective US claims analysis of commercially insured patients. Managing the challenges of paying for gene therapy: strategies for market action and policy reform in the United States.
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