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
• Janssen has been made aware that a limited number of hospitals in the US are having difficulty sourcing the evacuated sterile glass bottles required to dilute reconstituted IV UPTRAVI. There are no supply or quality issues with the primary IV UPTRAVI vial supply for the primary product pack. This shortage is strictly related to the sterile glass bottle. The company is working with supply chain and distribution partners to help identify a resolution for affected hospitals.¹
• To obtain sterile glass containers for IV UPTRAVI, healthcare providers should reach out to their hospital's distributor to inquire on availability. Other distributors such as Healthcare Logistics may have availability, but it is the responsibility of the healthcare provider to verify availability.^1,3
• 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

Current Availability of Sterile Glass Bottles

Janssen has been made aware that a limited number of hospitals in the US are having difficulty sourcing the evacuated sterile glass bottles required to dilute reconstituted IV UPTRAVI. There are no supply or quality issues with the primary IV UPTRAVI vial supply for the primary product pack. This shortage is strictly related to the sterile glass bottle, which is produced by other companies and sourced separately, and is currently required to dilute reconstituted medication.¹

Janssen is working with supply chain and distribution partners to help identify a resolution for affected hospitals. Other long-term alternative ways to dilute and administer IV UPTRAVI are also currently being evaluated. In the interim, it is important to note that IV UPTRAVI should only be diluted according to the UPTRAVI USPI.^1,2

To obtain sterile glass containers for IV UPTRAVI, healthcare providers should reach out to their hospital's distributor to inquire on availability. If the hospital’s distributor doesn’t have the glass containers, please continue to work through the hospital’s processes and distributors. Other distributors such as Healthcare Logistics may have availability, but it is the responsibility of the healthcare provider to verify availability.^1,3

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-primingvolume13mllength127in.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^®, Derwent^® (and/or other resources, including internal/external databases) was conducted on 30 January 2024.