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HEPATITIS B POSES AN IMMEDIATE THREAT TO SEXUAL ASSAULT PATIENTS

  • HBV is 50 to 100 times more infectious than HIV1
  • Due to bleeding and trauma to tissues, as well as possible exposure at multiple sites, the risk of blood-borne infections being transmitted after a sexual assault is greater than with consensual sex2,3
  • Incidence of HBV exposure during sexual assault is unknown since the HBV status of perpetrators is rarely known4

Once someone is exposed to HBV and remains unprotected, HBV may
take hold and develop into potentially deadly chronic liver disease7

HBV=hepatitis B virus; HIV=human immunodeficiency virus; STIs=sexually transmitted infections.

Hepatitis B seroprotection remains a serious issue

  • The HBV vaccine series alone takes up to 2 weeks to achieve initial serum levels and 3 doses (6 months) to provide seroprotection in ~90% of patients8-10
  • Waning serum antibody levels may compromise seroprotection over time
  • Among immunocompetent HBV vaccine responders, protection lasts 15 to 20 years8
  • Response can be compromised due to smoking history, obesity, age, chronic medical conditions, compromised immune system, or gender (male)8

What immediate steps will you take to help protect your
patients from developing a chronic HBV infection?

Nabi-HB® PROVIDES PROTECTION AGAINST HEPATITIS B INFECTION WITHIN 24 HOURS OF ADMINISTRATION12,13

Guaranteed potency with Nabi-HB12

  • Each milliliter of Nabi-HB contains >312 IU of anti-HBs
  • The potency of each milliliter of Nabi-HB exceeds the potency of anti-HBs in a US reference hepatitis B immune globulin (FDA). The US reference has been tested against the WHO standard and found to be equal to 208 IU/mL

Anti-HBs=anti-hepatitis B surface antibodies; IU=international units; WHO=World Health Organization.

Nabi-HB® + HBV VACCINE SERIES DELIVERS HIGHLY EFFECTIVE PROTECTION12

CDC Recommendations for Prophylaxis:
Administering an HBIG with the HBV vaccine series is highly effective in
preventing transmission following exposure to HBV14

Nabi-HB® WAS WELL TOLERATED AND REACTIONS REPORTED WERE MILD

  • In clinical trials, the majority (92%) of reactions were reported as mild12

    Patients with mild reactions related to the administration of Nabi-HB (N=50)12

    https://www.google.com 

    AST=aspartate transaminase; WBC=white blood cells.

  • No anaphylactic reactions with Nabi-HB have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins12

Nabi-HB® IS DEVELOPED THROUGH A SAFETY-FIRST MANUFACTURING PROCESS

  • Manufactured solely from US plasma from the Food and Drug Administration (FDA)-licensed plasma collection centers
  • Produced using a manufacturing process based on cold ethanol fractionation followed by ion exchange chromatography

Three virus inactivation/removal steps

  1. Precipitation and removal of fraction III of the cold ethanol process removes some nonenveloped viruses
  2. Solvent/detergent treatment designed to inactivate enveloped viruses
  3. Nanofiltration with 35 nm filters to remove nonenveloped and enveloped viruses

Viral safety built into manufacturing

  • Multistep viral removal/activation system that eliminates and inactivates viruses to further ensure the safety of Nabi-HB
    • Because this product is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Nabi-HB is a market leader with a proven safety profile12,13

References:

  1. Centers for Disease Control and Prevention. Hepatitis B FAQs for the public. https://www.cdc.gov/hepatitis/hbv/bfaq.htm. Accessed January 11, 2018.
  2. Centers for Disease Control and Prevention. Updated guidelines for antiretroviral post-exposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV—United States, 2016. https://www.cdc.gov/hiv/pdf/programresources/cdc-hiv-npep-guidelines.pdf. Accessed January 18, 2018.
  3. Middlesex-London Health Unit. Post exposure management: hepatitis B, hepatitis C and HIV. https://webcache.googleusercontent.com/search?q= cache:yv8rPNtV2AoJ:https://www.healthunit.com/uploads/post-exposure-management-hepatitis-b-hepatitis-c-and-hiv.pdf+&cd=1&hl=en&ct=clnk&gl=us. Accessed January 18, 2018.
  4. Roberts JR, Custalow CB, Thomsen TW, et al. Roberts and Hedges’ Clinical Procedures in Emergency Medicine and Acute Care. 7th ed. Philadelphia, PA: Elsevier; 2019.
  5. Centers for Disease Control and Prevention. Sexual violence: facts at a glance 2012. https://www.cdc.gov/ violenceprevention/pdf/sv-datasheet-a.pdf. Accessed January 18, 2018.
  6. Cantor D, Fisher B, Chibnall S, et al. Report on the AAU campus climate survey on sexual assault and sexual misconduct. Rockville, MD: Westat.
  7. World Health Organization. Hepatitis B fact sheet: http://www.who.int/mediacentre/ factsheets/fs204/en. Accessed January 17, 2018.
  8. Centers for Disease Control and Prevention. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) part 2: immunization of infants, children, and adolescents. MMWR Recomm Rep. 2006;55(RR-16):1-40.
  9. Junewicz A, Brateanu A, Nielsen C. Q: do patients who received only two doses of hepatitis B vaccine need a booster? Cleve Clin J Med. 2014;81(6):346-348.
  10. PDR: prescriber’s digital reference. Engerix (hepatitis B vaccine recombinant) drug summary: http://www.pdr.net/drug-summary/Engerix-B-hepatitis-B-vaccine–recombinant–186. Accessed January 17, 2018.
  11. Nabi-HB [Prescribing Information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; 2008.
  12. Data on file. Final Clinical and Statistical Report of Nabi-4202. ADMA Biologics.
  13. Data on file, ADMA, Biologics.
  14. Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64(RR-03):1-137.

Important Safety Information for Nabi-HB®

Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB® [Hepatitis B Immune Globulin (Human)] or any other human immune globulin. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB should be given only if the expected benefits outweigh the potential risks.

Nabi-HB is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents (e.g., viruses) and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Nabi-HB [Hepatitis B Immune Globulin (Human)], must be administered only intramuscularly for post-exposure prophylaxis.

Vaccination with live virus vaccines (e.g., MMR) should be deferred until approximately three months after administration of Nabi-HB.

The most common adverse reactions associated with Nabi-HB in clinical trials were erythema and ache at the injection site as well as systemic reactions such as headache, myalgia, malaise, nausea and vomiting. No anaphylactic reactions with Nabi-HB have been reported.

Please see the full Prescribing Information for Nabi-HB [Hepatitis B Immune Globulin (Human)].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.

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