Advances in Trace Element Supplementation for Parenteral Nutrition

Abstract

Parenteral nutrition (PN) provides support for patients lacking sufficient intestinal absorption of nutrients. Historically, the need for trace element (TE) supplementation was poorly appreciated, and multi-TE products were not initially subjected to rigorous oversight by the United States Food and Drug Administration (FDA). Subsequently, the American Society for Parenteral and Enteral Nutrition (ASPEN) issued dosage recommendations for PN, which are updated periodically. The FDA has implemented review and approval processes to ensure access to safer and more effective TE products. The development of a multi-TE product meeting ASPEN recommendations and FDA requirements is the result of a partnership between the FDA, industry, and clinicians with expertise in PN. This article examines the rationale for the development of TRALEMENT^® (Trace Elements Injection 4*) and the FDA's rigorous requirements leading to its review and approval. This combination product contains copper, manganese, selenium, and zinc and is indicated for use in adults and pediatric patients weighing ≥10 kg. Comprehensive management of PN therapy requires consideration of many factors when prescribing, reviewing, preparing, and administering PN, as well as monitoring the nutritional status of patients receiving PN. Understanding patients' TE requirements and incorporating them into PN is an important part of contemporary PN therapy.

Keywords: adults; children; copper; manganese; micronutrient; parenteral nutrition; selenium; trace elements; zinc.

Figure 1

Timeline in the development of current US recommendations for dosing of trace elements in parenteral nutrition [8]. AMA, American Medical Association; ASCN, American Society for Clinical Nutrition; ASPEN, American Society for Parenteral and Enteral Nutrition; Cr, chromium; FDA, United States Food and Drug Administration; Mn, manganese; NAG, Nutrition Advisory Group; PN, parenteral nutrition; Se, selenium; US, United States; Zn, zinc.

Figure 2

Summary of review materials and analysis included in literature assessments for 505(b)(2) NDA 209376 submission. ASPEN, American Society for Parenteral and Enteral Nutrition; FDA, United States Food and Drug Administration; IND, investigational new drug application; IR, information request; IOM, Institute of Medicine; NDA, new drug application; PMR, postmarketing requirement; PN, parenteral nutrition; TE, trace element.