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9/27/2021

Protamine Sulfate Injection

Products Affected - Description

    • Protamine injection, Fresenius Kabi, 10 mg/mL, 25 mL vial, 1 count, NDC 63323-0229-30
    • Protamine injection, Fresenius Kabi, 10 mg/mL, 5 mL vial, 25 count, NDC 63323-0229-05

Reason for the Shortage

    • Fresenius Kabi has protamine on shortage due to manufacturing delays. A customer letter detailing the issue can be found at: http://editor.fresenius-kabi.us/PIUs/Protamine_Sulfate_Supply_Update_04_16_2021.pdf.

Available Products

    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Fresenius Kabi has protamine 10 mg/mL 5 mL and 25 mL vials on back order and the company estimates a release date of late-September to early-October 2021 for the 5 mL vials and early-November 2021 for the 25 mL vials. Check wholesalers for inventory.

Alternative Agents & Management

    • Consider using bivalirudin for cardiopulmonary bypass surgery to prevent the need for protamine due to heparin use. The Society of Thoracic Surgeons, Society of Cardiovascular Anesthesiologists, and the American Society of ExtraCorporeal Technology created clinical practice guidelines for anticoagulation during cardiopulmonary bypass that were published in 2018. These can be found at https://www.annalsthoracicsurgery.org/action/showPdf?pii=S0003-4975%2817%2931478-9. These include dosing information from the CHOOSE-ON and EVOLUTION-ON trials.
    • Bivalirudin starting doses in the CHOOSE-ON and EVOLUTION-ON trials included a loading dose of 1 mg/kg, maintenance infusion of 2.5 mg/kg/hr, and pump prime bolus of 50 mg.

Updated

Updated September 27, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. Created March 2, 2021 by Michelle Wheeler, PharmD, Drug Information Specialist. © 2021, Drug Information Service, University of Utah, Salt Lake City, UT.

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Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. ASHP and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this Bulletin. Neither ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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