SUMMARY

• Intravenous (IV) UPTRAVI is light sensitive and loses potency when exposed to light. The UPTRAVI United States (US) Prescribing Information (USPI) indicates that the sterile glass container and IV tubing must be wrapped with a light protective cover.^1,2
• A list of infusion sets that were used in the IV UPTRAVI study and met the criteria are listed below.

AVAILABLE DATA

IV UPTRAVI is light sensitive and loses potency when exposed to light. The UPTRAVI USPI indicates that the sterile glass container and IV tubing must be wrapped with a light protective cover. Amber IV bags and amber IV tube covers are an option for suitable protective covers depending on hospital policy. Another option is to use aluminum foil depending on the hospital’s policy.^1,2

Rationale for Glass Containers

Sterile glass containers are required to further dilute reconstituted UPTRAVI IV. In examining IV UPTRAVI stability in various containers including standard hospital IV bags, the total amount of drug recovered at the end of the infusion must be within 90-110% drug product as per the Food and Drug Administration (FDA) requirements. For glass containers, this requirement was met from the lowest dose (225 mcg) to highest dose (1800 mcg). Other common hospital IV bags made of polyvinyl chloride (PVC), DEHP, and polyurethane were identified in the same testing to be out of the 90-110% specification, thus not suitable for use with IV UPTRAVI.¹

The UPTRAVI USPI recommends glass containers as the only material tested to meet FDA requirements.² No other common IV bag meets specifications at this time.¹

Infusion Sets on the US Market

As indicated in the UPTRAVI label instructions, sterile glass container for dilution, using a single, appropriately sized polypropylene syringe and infusion set made of DEHP free PVC, and natural latex rubber-free microbore tubing met the criteria in the study.¹ Here are the infusion sets that were used in the IV UPTRAVI study and met the criteria:

• B. Braun Infusomat^® Space Pump IV Set Reference Number: 490038¹
  • Infusion line PVC, non-DEHP and natural latex and rubber free microbore tubing material
  • Link to B.Braun Infusomat^® Space Pump IV set https://www.bbraunusa.com/en/products/b0/60-drops-ml-primingvolume11mllength129in.html
• Alaris™ GP Primary Set Reference Number 63260NY¹
  • Infusion line PE-lined PVC, natural latex, and rubber free tubing material BD IV therapy
  • Link to BD IV Therapy - Alaris™ GP Primary Set - https://www.bd-products.com/products/ivsets/product.php?ID=1200

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 26 November 2024.