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Hepatitis B Vaccine Recombinant

Last Updated: January 16, 2018
Status: Resolved

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)
Adult Dose 10 mcg/mL, 1 mL single dose vial, 1 count (NDC 00006-4995-00)
Adult Dose 10 mcg/mL, 1 mL single dose vial, 10 count (NDC 00006-4995-41)
Pediatric/Adolescent Dose 5 mcg/ 0.5 mL, 0.5 mL Luer Lock syringe, 10 count (NDC 00006-4093-02)
Pediatric/Adolescent Dose 5 mcg/ 0.5 mL, 0.5 mL single dose vial, 10 count (NDC 00006-4981-00)
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
    Adult Dose 20 mcg/mL, 1 mL single dose vial, 10 count (NDC 58160-0821-11)
    Adult Dose 20 mcg/mL, 1 mL syringe, 10 count (NDC 58160-0821-52)
    Pediatric/Adolescent Dose 10 mcg/ 0.5mL, 0.5 mL syringe, 10 count, (NDC 58160-0820-52)

 
Recombivax HB Dialysis Formulation suspension for injection, Merck
Dialysis Formulation 40 mcg/mL, 1 mL single dose vial, 1 count (NDC 00006-4992-00)

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 a release date of early-April 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.

Updated

January 16, 2018; November 7, August 25, July 21, June 27, May 16, 2017, University of Utah, Drug Information Service. Copyright 2018, Drug Information Service, University of Utah, Salt Lake City, UT.

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