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Hepatitis B Vaccine (Recombinant)

Last Updated: July 9, 2018
Status: Current

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
    • Engerix-B suspension for injection, GlaxoSmithKline, Adult Dose 20 mcg/mL, 1 mL syringe, 10 count, NDC 58160-0821-52
    • 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 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

Estimated Resupply Dates

    • Merck has Recombivax HB adult formulation vials and syringes on back order and the company estimates this will continue through 2018.
    • Merck has Recombivax HB pediatric/adolescent formulation syringes and pediatric/adolescent vials on back order and the company estimates this will continue through 2018. 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 2018.
    • GlaxoSmithKline has Engerix-B adult 20 mcg/mL 1 mL syringes on back order and the company estimates a release date in mid-July 2018.

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 July 9, 2018 by Leslie Jensen, PharmD, Drug Information Specialist. Created May 16, 2017 by Leslie Jensen, PharmD, Drug Information Specialist. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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