Prehevbrio

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Prehevbrio Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Hepatitis B vaccine (recombinant) 10mcg/mL; susp for IM inj; aluminum hydroxide adsorbed; preservative-free.

    Pharmacological Class

    HB.

    How Supplied

    Single-dose vials—1,10

    Storage

    Store in a refrigerator at 2° C to 8° C (36° F to 46° F). Protect from light.
    Do not freeze; discard if the vaccine has been frozen.
    Do not use the vaccine after the expiration date shown on the vial label.

    Manufacturer

    VBI Vaccines, Inc

    Generic Availability

    NO

    Mechanism of Action

    Prehevbrio induces antibodies to HBsAg. Antibody concentrations ≥10mIU/mL against HBsAg are recognized as conferring protection against hepatitis B virus infection.

    Prehevbrio Indications

    Indications

    Hepatitis B immunization.

    Prehevbrio Dosage and Administration

    Adult

    Give IM inj in deltoid muscle. ≥18yrs: 10mcg (1mL) at elected date; repeat 1 and 6 months later.

    Children

    <18yrs: not established.

    Prehevbrio Contraindications

    Contraindications

    Severe allergic reaction (including anaphylaxis) after a previous dose of any hepatitis B vaccine.

    Prehevbrio Boxed Warnings

    Not Applicable

    Prehevbrio Warnings/Precautions

    Warnings/Precautions

    Immunocompromised. Have epinephrine inj available. Limited effectiveness due to unrecognized hepatitis B infection status at time of administration. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Immunocompromised Individuals

    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to Prehevbrio.

    Limitations of Vaccine Effectiveness

    • Hepatitis B has a long incubation period. Prehevbrio may not prevent hepatitis B infection in those who have an unrecognized hepatitis B infection at the time of vaccine administration.

    Pregnancy Considerations

    There are no adequate and well-controlled studies of Prehevbrio in pregnant women. Available human data on Prehevbrio administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

    Nursing Mother Considerations

    It is not known whether Prehevbrio is excreted in human milk. Data are not available to assess the effects of Prehevbrio on the breastfed infant or on milk production/excretion.

    Consider the benefits of breastfeeding along with the mother's clinical need for Prehevbrio and any potential adverse effects on the breastfed child from Prehevbrio or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness of Prehevbrio have not been established in individuals <18 years of age.

    Geriatric Considerations

    In Study 1, among patients who received Prehevbrio, a seroprotective level of antibody to HBsAg was achieved in 83.6% of those ≥ 65 years of age compared to 94.8% in adults 45 through 64 years of age and 99.2% in adults 18 through 44 years of age.

    Frequencies of local and systemic solicited adverse reactions were generally lower in elderly subjects ≥65 years of age than in younger subjects.

    Other Considerations for Specific Populations

    Safety and effectiveness of Prehevbrio have not been established in adults on hemodialysis.

    Prehevbrio Pharmacokinetics

    See Literature

    Prehevbrio Interactions

    Interactions

    Concomitant immunosuppressants; may get sub-optimal response. Concomitant immune globulin; give separately using different syringes at different inj sites. May interfere with lab tests.

    Prehevbrio Adverse Reactions

    Adverse Reactions

    Inj site pain, tenderness, headache, fatigue, myalgia.

    Prehevbrio Clinical Trials

    Clinical Trials

    The immunogenicity of Prehevbrio was evaluated in comparison with a US-licensed hepatitis B vaccine (Engerix-B) in 2 randomized, active controlled, double-blind, multi-center Phase 3 clinical trials in adults. Prehevbrio and Engerix-B were administered according to a 0-, 1- and 6-month schedule. The trials compared the seroprotection rates (SPR), defined as the proportion of participants with anti-HBs titers ≥10 mIU/mL, induced by Prehevbrio and Engerix-B. Non-inferiority was met if the lower bound of the 95% confidence interval (CI) of the difference in SPR (Prehevbrio minus Engerix-B) was greater than -5%.

    Study 1 in adults ≥18 years of age

    The immunogenicity population included patients who received Prehevbrio (n=718) and those who received Engerix-B (n=723). The mean age was 57 years in both groups. The primary analysis compared the SPR, 4 weeks after receiving the third dose of Prehevbrio or Engerix-B in patients ≥18 years of age. The SPR induced by Prehevbrio compared to Engerix-B was non-inferior in patients ≥18 years of age.

    • The results were:
      All adults (age 18+):
      • Prehevbrio: 91.4% (95% CI, 89.1-93.3); Engerix-B: 76.5% (95% CI, 73.2-79.5); Difference in SPR: 14.9% (95% CI, 11.2-18.6).
    • Age 45+ group:
      • Prehevbrio: 89.4% (95% CI, 86.8-91.7); Engerix-B: 73.1% (95% CI, 69.4-76.5); Difference in SPR: 16.4%; 95% CI, 12.2-20.7).

    Study 2 in adults 18 through 45 years of age

    The immunogenicity population included patients who received Prehevbrio (n=1753) and those who received Engerix-B (n=592). The mean age was 34 years in the Prehevbrio group and 33 years in the Engerix-B group. The study compared the SPR, 4 weeks after receiving the third dose of Prehevbrio or Engerix-B in all patients. The SPR induced by Prehevbrio compared to Engerix-B was non-inferior.

    • The results were:
      Age 18-45:
      • Prehevbrio: 99.3% (95% CI, 98.7-99.6); Engerix-B: 94.8% (95% CI, 92.7-96.4); Difference in SPR: 4.5% (95% CI, 2.9-6.6).

    Prehevbrio Note

    Notes

    For the Pregnancy Exposure Registry: call (888) 421-8808.

    Prehevbrio Patient Counseling

    Patient Counseling

    Inform vaccine recipient of the potential benefits and risks associated with vaccination, as well as the importance of completing the immunization series.

    Emphasize that Prehevbrio contains non-infectious purified HBsAg and cannot cause hepatitis B infection.

    Advise to report any adverse events to their healthcare provider.

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