Vizient offers mitigation strategy for Iohexol (Omnipaque) shortage

Vizient, an ICAHN Preferred Partner, offers the following mitigation strategy for handling ongoing drug shortages:

Drug Shortage: Iohexol (Omnipaque) solution

Information is compiled from mitigation strategies of institutions that serve on the Vizient Clinical Pharmacy Council and is reviewed by a panel of pharmacists. For more information, contact pharmacyquestions@vizientinc.com.

Situation
This mitigation strategy is to serve as a resource if iohexol (Omnipaque) experiences supply disruptions due to
shortages.

Background
According to communication from GE Healthcare, a drug shortage is occurring as a result of the Chinese
government lockdowns related to COVID-19. Nearly all of the U.S. supply for this product comes from the Shanghai
plant. The supply impact is not related to quality, raw material supply, or supply chain issues. Additionally, GE has
communicated that the impact is temporary, and the facility is now open again and ramping up production as allowed
by local COVID-19 mitigation protocols. GE expects to have intermittent impact to supply until the end of June 2022.
This mitigation strategy is intended to provide guidance for present and future shortages.

Products Affected
Omnipaque 140 ▪ 140 mg iodine/mL, 50 mL polymer bottle
Omnipaque 180 ▪ 180 mg iodine/mL, 10, 20 mL vials
Omnipaque 240▪ 240 mg iodine/mL, 10, 20 mL vials▪ 240 mg iodine/mL, 50, 100, 150, 200 mL polymer bottles
Omnipaque 300▪ 300 mg iodine/mL, 10, 125 mL vials▪ 300 mg iodine/mL, 30, 50, 75, 100, 125, 150, 200 mL polymer bottles
Omnipaque 350▪ 350 mg iodine/mL, 125 mL vials▪ 350 mg iodine/mL, 50, 75, 100, 125, 150, 200 mL polymer bottles
Omnipaque Oral solution 9 ▪ 9 mg iodine/mL, 500 mL polymer bottle
Omnipaque Oral solution 12 ▪ 12 mg iodine/mL, 500 mL polymer bottle
* Review ASHP Drug Shortages for the most current information

Assessment
Iohexol (Omnipaque) is an iodinated contrast media, specifically a low-osmolality contrast media (LOCM). It is
utilized in computed tomography (CT) scans and X-rays for oral and body cavity, intravascular, intraarterial, and
intrathecal imaging. Other iodinated contrast media, in the LOCM class, include iodixanol (Visipaque), iopamidol
(Isovue), iopromide (Ultravist), and ioversol (Optiray). Iopromide (Ultravist) and ioversol (Optiray) are manufactured
by Bayer and Guerbet, respectively, and account for approximately ≤ 5% of the market share combined. Iopamidol
(Isovue), manufactured by Bracco Diagnostics, accounts for the second largest market share, but is not currently
accepting new clients (accurate as of 05/01/2022). Iohexol (Omnipaque) and iodixanol (Visipaque), manufactured
by GE, account for the largest market share at > 50%. These contrast agents are necessary for imaging studies to
determine the appropriate diagnosis and subsequent treatment of patients for a variety of disease states. Hospitals
and health systems are advised to have a mitigation strategy available, to conserve inventory, in the event of a
shortage of these contrast agents.

Recommendation
Must know information
• Vizient is continuing to solicit feedback from members regarding how to manage this supply disruption,
including prioritization of certain imaging studies. This mitigation strategy will be updated, and the information
shared as it becomes available.
• Reschedule non-emergent imaging studies or interventional studies which require iohexol (Omnipaque) or
other LOCM agents to conserve available inventory.
• Reserve iohexol (Omnipaque) for critically ill patients requiring CT studies or cardiac catherization lab
interventions.
• Utilize other LOCM agents, such as iodixanol (Visipaque), in coordination with radiology representatives, as
supply allows.
• For oral solution iohexol (Omnipaque) used for X-rays, diatrizoate meglumine and diatrizoate sodium
solutions (MD-Gastroview and Gastrografin) can be utilized as alternatives.

Clinical
1) Reserve iohexol (Omnipaque) for critically ill patients requiring CT studies or cardiac catherization lab
interventions.
o Determine which patients qualify as critically ill with input from the appropriate hospital and
pharmacy leadership bodies, in coordination with radiologists.
o Consult with GE Medical Affairs (800-654-0118 or medical.affairs@ge.com) to evaluate reduction
of contrast load where clinically appropriate.
o If clinically appropriate, in coordination with radiologists, utilize other imaging study modalities such
as magnetic resonance imaging (MRI), ultrasound, or nuclear studies.
2) Utilize other LOCM agents, such as iodixanol (Visipaque), in coordination with radiology representatives,
as supply allows.
3) If utilizing iodixanol (Visipaque) in the catherization lab, reserve for patients with renal insufficiency or
cardiac issues.
4) For oral solution iohexol (Omnipaque) used for X-rays, diatrizoate meglumine and diatrizoate sodium
solutions (MD-Gastroview and Gastrografin) can be utilized as alternatives.

Operational
1) If inventory becomes critically low, reschedule non-emergent imaging or interventional studies which
require iohexol (Omnipaque) or other LOCM agents to conserve available inventory.
2) For single dose iohexol (Omnipaque) vials, assess and evaluate extending the beyond-use time for up to 6
hours after initial puncture if in ISO Class 5 or cleaner air, per USP 797.
3) Coordinate direct orders with GE and/or monitor availability with wholesaler. If wholesalers allocate iohexol (Omnipaque), ensure the allocated quantity is accurate based on previous purchase quantities.