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11/9/2022

Albumin (Human) Injection

Products Affected - Description

    • Albuked intravenous solution for injection, Kedrion Biopharma, Inc., Albumin (human) 25%, 12.5 grams protein/50 mL vial, NDC 76125-0792-25
    • Albuked intravenous solution for injection, Kedrion Biopharma, Inc., Albumin (human) 25%, 25 grams protein/100 mL vial, NDC 76125-0792-10
    • Albuked intravenous solution for injection, Kedrion Biopharma, Inc., Albumin (human) 5%, 12.5 grams protein/250 mL vial, NDC 76125-0790-25
    • Albumin intravenous solution for injection, Octapharma, Albumin (human) 25%, 25 grams protein/100 mL vial, NDC 67467-0643-02
    • Albumin intravenous solution for injection, Octapharma, Albumin (human) 5%, 12.5 grams protein/250 mL vial, NDC 67467-0623-02
    • Albumin intravenous solution for injection, Octapharma, Albumin (human) 5%, 25 grams protein/500 mL vial, NDC 67467-0623-03
    • Albutein intravenous solution for injection, Grifols, Albumin (human) 25%, 12.5 grams protein/50 mL vial, NDC 68516-5216-01
    • Albutein intravenous solution for injection, Grifols, Albumin (human) 25%, 25 grams protein/100 mL vial, NDC 68516-5216-02
    • Albutein intravenous solution for injection, Grifols, Albumin (human) 5%, 12.5 grams protein/250 mL vial, NDC 68516-5214-01
    • Albutein intravenous solution for injection, Grifols, Albumin (human) 5%, 25 grams protein/500 mL vial, NDC 68516-5214-02
    • Flexbumin intravenous solution for injection, Takeda, Albumin (human) 25%, 12.5 grams protein/50 mL vial, NDC 00944-0493-01
    • Flexbumin intravenous solution for injection, Takeda, Albumin (human) 25%, 25 grams protein/100 mL vial, NDC 00944-0493-02
    • Flexbumin intravenous solution for injection, Takeda, Albumin (human) 5%, 12.5 grams protein/250 mL vial, NDC 00944-0495-05

Reason for the Shortage

    • Kedrion did not provide a reason for the shortage.
    • Octapharma did not provide a reason for the shortage.
    • CSL Behring has AlbuRx available and shipping.
    • Takeda states the shortage is due to increased demand.
    • Grifols did not provide a reason for the shortage.

Available Products

    • AlbuRx intravenous solution for injection, CSL Behring, Albumin (human) 25%, 12.5 grams protein/50 mL vial, NDC 44206-0251-05
    • AlbuRx intravenous solution for injection, CSL Behring, Albumin (human) 25%, 25 grams protein/100 mL vial, NDC 44206-0251-10
    • AlbuRx intravenous solution for injection, CSL Behring, Albumin (human) 5%, 12.5 grams protein/250 mL vial, NDC 44206-0310-25
    • AlbuRx intravenous solution for injection, CSL Behring, Albumin (human) 5%, 25 grams protein/500 mL vial, NDC 44206-0310-50
    • Albumin intravenous solution for injection, Octapharma, Albumin (human) 25%, 12.5 grams protein/50 mL vial, NDC 67467-0643-01

Estimated Resupply Dates

    • Grifols has Albutein 5% and 25% on intermittent back order and the company is releasing supplies as they become available.
    • Kedrion has Albuked 5% in 250 mL and 25% in 50 mL and 100 mL on allocation.
    • Octapharma has Albumin 5% in 250 mL and 500 mL in limited supply. The 25% in 100 mL vials are also in limited supply.
    • Takeda has Flexbumin 5% and 25% on back order and the company cannot estimate a release date.

Implications for Patient Care

    • Albumin 5% solution is used for hypovolemic patients or intravascularly depleted patients.[1]
    • Albumin 25% solution is used for patients in whom fluid and sodium intake is restricted or to mobilize fluids.[1]

Alternative Agents & Management

    • Albumin 4% to 5% solution is recommended for therapeutic plasma exchange as the replacement fluid of choice. Other crystalloids are not recommended due to insufficient oncotic pressure and may result in edema or hypotension. If an albumin-saline combination is used for these patients, at least 50% of the total volume infused should be albumin.[1-2]
    • For postoperative hypovolemia, the Society for Critical Care Medicine has a strong recommendation (with moderate-quality evidence) for the use of crystalloid solutions for initial management. There is a weak recommendation (with low-quality evidence) to use albumin 4% to 5% in addition to crystalloids in patients with severe sepsis or septic shock.[3]
    • Compatibility data regarding using a Y-site with albumin 25% and fluids in order to mimic albumin 5% are not available.[4]
    • There are data for diluting albumin 25% with 0.9% sodium chloride or 5% dextrose to make albumin 5%.[5]

References

    1. Lexi-Drugs Online. Hudson, OH. Lexi-Comp, Inc.; 2022. https://online.lexi.com. Accessed October 7, 2022.
    2. IBM Micromedex [database online]. Greenwood Village, CO: IBM Corporation.; 2022. http://www.micromedexsolutions.com. Accessed October 7, 2022.
    3. Dynamed. Postoperative Fluid Therapy in Adults. EBSCO Information Services. Accessed October 7, 2022.
    4. Trissel's IV Compatibility [database online]. Hudson, OH. Lexi-Comp, Inc.; 2022. https://online.lexi.com. Accessed October 7, 2022.
    5. Albutein 25% prescribing information. Los Angeles, CA: Grifols Biologicals LLC., April 2022.

Updated

Updated November 9, 2022 by Elyse MacDonald, PharmD, MS, BCPS. Created September 23, 2022 by Leslie Jensen, PharmD, Drug Information Specialist. © 2022, Drug Information Service, University of Utah, Salt Lake City, UT.

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