Heplisav-b

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  • Vaccines
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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

    • Heplisav-b Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Hepatitis B vaccine (recombinant), adjuvanted (formulated to contain HBsAg 20mcg + CpG 1018 3000mcg) per 0.5mL dose; soln for IM inj; preservative-free.

    Pharmacological Class

    HB.

    How Supplied

    Single-dose vials—1, 5

    Storage

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

    Manufacturer

    Dynavax Technologies

    Generic Availability

    NO

    Mechanism of Action

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

    Heplisav-b Indications

    Indications

    Hepatitis B immunization.

    Heplisav-b Dosage and Administration

    Adult

    Give IM inj in deltoid muscle. ≥18yrs: 2 doses (0.5mL each) 1 month apart.

    Children

    <18yrs: not established.

    Heplisav-b Contraindications

    Contraindications

    Yeast hypersensitivity.

    Heplisav-b Boxed Warnings

    Not Applicable

    Heplisav-b Warnings/Precautions

    Warnings/Precautions

    Have appropriate medical treatment available to manage possible anaphylactic reactions. Immunocompromised. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Immunocompromised Individuals

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

    Limitations of Vaccine Effectiveness

    • Hepatitis B has a long incubation period. Heplisav-B 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 clinical studies of Heplisav-B in pregnant women. Available human data on Heplisav-B administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

    Nursing Mother Considerations

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

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

    Pediatric Considerations

    Safety and effectiveness of Heplisav-B have not been established in individuals >18 years of age.

    Geriatric Considerations

    Clinical trials included 909 adults 65 through 70 years of age who received Heplisav-B.

    Among patients who received Heplisav-B, a seroprotective level of antibody to HBsAg was achieved in 90% of those 65 through 70 years of age versus 96% of those aged 18 through 64 years of age.

    Safety and effectiveness of Heplisav-B in adults older than 70 years of age were extrapolated from findings in patients younger than 70 years of age.

    Other Considerations for Specific Populations

    Safety and effectiveness of Heplisav-B have not been established in adults on hemodialysis.

    Heplisav-b Pharmacokinetics

    See Literature

    Heplisav-b 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.

    Heplisav-b Adverse Reactions

    Adverse Reactions

    Local reactions (eg, pain, redness, swelling), fatigue, headache, malaise; anaphylaxis.

    Heplisav-b Clinical Trials

    Clinical Trials

    The immunogenicity of Heplisav-B was assessed in comparison with a licensed hepatitis B vaccine (Engerix-B) in 3 randomized, active controlled, observer-blinded, multi-center Phase 3 clinical trials of adults. Heplisav-B was given as a 2-dose regimen at 0 and 1 months followed by saline placebo at 6 months. Engerix-B was given at 0, 1, and 6 months.

    The trials compared the seroprotection rates (% with antibody concentration ≥10 mIU/mL) induced by Heplisav-B and Engerix-B. Noninferiority was met if the lower bound of the 95% confidence interval of the difference in seroprotection rates (Heplisav-B minus Engerix-B) was greater than -10%.

    Study 1 (Seroprotection in Adults 18-55 Years of Age)

    • In Study 1, the immunogenicity population comprised of participants who received Heplisav-B (n=1511) and those who received Engerix-B (n=521). The mean age was 40 years for both groups. The primary analysis compared the seroprotection rate at Week 12 for Heplisav-B with that at Week 28 for Engerix-B. Non-inferiority of the seroprotection rate induced by Heplisav-B compared to Engerix-B was demonstrated as 95% (95% CI, 93.9-96.1) and 81.3% (95% CI, 77.8-84.6), respectively. The difference in seroprotection rates was 13.7% (95% CI, 10.4-17.5).

    Study 2 (Seroprotection in Adults 40-70 Years of Age)

    • In Study 2, the immunogenicity population comprised of patients who received Heplisav-B (n=1121) and those who received Engerix-B (n=353). The mean age was 54 years for both groups. The primary analysis compared the seroprotection rate at Week 12 for Heplisav-B with that at Week 32 for Engerix-B. Non-inferiority of the seroprotection rate induced by Heplisav-B compared to Engerix-B was demonstrated as 90.1% (95% CI, 88.2-91.8) and 70.5% (95% CI, 65.5-75.2), respectively. The difference in seroprotection rates was 19.6% (95% CI, 14.7-24.8).

    Study 3 (Seroprotection in Adults 18-70 Years of Age, Including those with Type 2 Diabetes Mellitus)

    • In Study 3, the immunogenicity population comprised of patients who received Heplisav-B (n=4537) and those who received Engerix-B (n=2289). The mean age was 51 years and 14% of patients had type 2 diabetes mellitus (defined as having a clinical diagnosis of type 2 diabetes and taking at least an oral or non-insulin injectable hypoglycemic agent and/or insulin).
    • The primary analysis compared the seroprotection rate at Week 28 for Heplisav-B (n= 640) with that at Week 28 for Engerix-B (n= 321) in patients with type 2 diabetes mellitus. Non-inferiority of the seroprotection rate induced by Heplisav-B compared to Engerix-B was demonstrated as 90.0% (95% CI, 87.4-92.2) and 65.1% (95% CI, 59.6-70.3), respectively. The difference in seroprotection rates was 24.9% (95% CI, 19.3-30.7).
    • A secondary analysis compared the seroprotection rate at Week 24 for Heplisav-B with that at Week 28 for Engerix-B in the total study population. Non-inferiority of the seroprotection rate induced by Heplisav-B compared to Engerix-B was demonstrated as 95.4% (95% CI, 94.8-96.0) and 81.3% (95% CI, 79.6-82.8), respectively. The difference in seroprotection rates was 14.2% (95% CI, 12.5-15.9).
    • Another secondary analysis compared the seroprotection rate at Week 24 for Heplisav-B with that at Week 28 for Engerix-B, by age group. For each age stratum non-inferiority of the seroprotection rate induced by Heplisav-B compared to Engerix-B was demonstrated in the following:
      • Age 18-29:  
        • Heplisav-B: 100.0% (95% CI, 97.9-100.0); Engerix-B: 93.9% (95% CI, 87.3-97.7); Difference in SPRs: 6.1% (95% CI, 2.8-12.6)
      • Age 30-39:  
        • Heplisav-B: 98.9% (95% CI, 97.7-99.6); Engerix-B: 92.0% (95% CI, 88.5-94.7); Difference in SPRs: 6.9% (95% CI, 4.2-10.4)
      • Age 40-49:  
        • Heplisav-B: 97.2% (95% CI, 96.0-98.2); Engerix-B: 84.2% (95% CI, 80.7-87.2); Difference in SPRs: 13.1% (95% CI, 9.9-16.6)
      • Age 50-59:  
        • Heplisav-B: 95.2% (95% CI, 94.0-96.3); Engerix-B: 79.7% (95% CI, 76.6-82.5); Difference in SPRs: 15.5% (95% CI, 12.6-18.7)
      • Age 60-70:  
        • Heplisav-B: 91.6% (95% CI, 89.9-93.1); Engerix-B: 72.6% (95% CI, 68.8-76.2); Difference in SPRs: 19.0% (95% CI, 15.2-23.0)

    Heplisav-b Note

    Notes

    For the Pregnancy Exposure Registry: call (844) 443-7734.

    Heplisav-b Patient Counseling

    Patient Counseling

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

    Emphasize that Heplisav-B 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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