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9/18/2019

Hepatitis B Vaccine (Recombinant)

Products Affected - Description

    • Engerix-B suspension for injection, GlaxoSmithKline, Pediatric/Adolescent Dose 10 mcg/ 0.5mL, 0.5 mL single dose vial, 10 count, NDC 58160-0820-11 - discontinued
    • Recombivax HB suspension for injection, Merck, Adult Dose 10 mcg/mL, 1 mL Luer Lock syringe, 10 count, NDC 00006-4094-02
    • Recombivax HB suspension for injection, Merck, Adult Dose 10 mcg/mL, 1 mL single dose vial, 1 count, NDC 00006-4995-00
    • Recombivax HB suspension for injection, Merck, Adult Dose 10 mcg/mL, 1 mL single dose vial, 10 count, NDC 00006-4995-41
    • Recombivax HB suspension for injection, Merck, Pediatric/Adolescent Dose 5 mcg/ 0.5 mL, 0.5 mL Luer Lock syringe, 10 count, NDC 00006-4093-02
    • Recombivax HB suspension for injection, Merck, Pediatric/Adolescent Dose 5 mcg/ 0.5 mL, 0.5 mL single dose vial, 10 count, NDC 00006-4981-00
    • Recombivax HB Dialysis Formulation suspension for injection, Merck, Dialysis Formulation 40 mcg/mL, 1 mL single dose vial, 1 count, NDC 00006-4992-00

Reason for the Shortage

    • Merck has Recombivax HB on shortage due to increase in global demand.
    • GlaxoSmithKline has Engerix B products available.
    • GlaxoSmithKline discontinued Engerix B pediatric vials in October 2017.

Available Products

    • Engerix-B suspension for injection, GlaxoSmithKline, Pediatric/Adolescent Dose 10 mcg/ 0.5mL, 0.5 mL syringe, 10 count, NDC 58160-0820-52
    • Engerix-B suspension for injection, GlaxoSmithKline, Adult Dose 20 mcg/mL, 1 mL single dose vial, 10 count, NDC 58160-0821-11
    • Engerix-B suspension for injection, GlaxoSmithKline, Adult Dose 20 mcg/mL, 1 mL syringe, 10 count, NDC 58160-0821-52

Estimated Resupply Dates

    • Merck has Recombivax HB adult formulation vials and syringes on back order and the company estimates this will continue through 2020.
    • Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent formulation vials in limited supply and this will continue through 2019. Merck's limited supply is being allocated to the CDC to ensure use is in accordance with their clinical guidance.
    • Merck has Recombivax HB dialysis formulation 40 mcg/mL on back order and the company estimates this will continue through 2020.

Implications for Patient Care

    • Recombivax HB adult and pediatric formulations are labeled for use in any age group as long as the correct volume/dose is given.
    • Engerix-B adult formulation may be used in patients aged 11 years and older. The pediatric formulation is only approved for patients under 20 years old.
    • More information on dosing of these medications can be found in the product labeling as well as the CDC site at https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepb.pdf.

Updated

Updated September 18, 2019 by Michelle Wheeler, PharmD, Drug Information Specialist. Created May 16, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. © 2019, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

This information is provided through the support of Vizient to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Vizient, 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, which 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 Vizient, 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 Vizient, ASHP nor University of Utah endorses or recommends the use of any drug.

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