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Nabi-HB Patient Site

Important Safety Information

Prescribing Information

Intended for U.S. audiences only

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Important Safety Information

Prescribing Information

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For acute exposure to hepatits B virusAct now to prevent HBV from taking hold forever

HEPATITIS B CAN POSE A SERIOUS THREAT

Without protection, an acute hepatitis B infection may develop into an incurable, contagious, and potentially deadly chronic infection1

In the United States alone:

  • ~22,000 acute* hepatitis B cases2
  • Up to 2.2 million people living with chronic hepatitis B3†
  • About 4000 people die from chronic hepatitis B–related cirrhosis and 1500 die from hepatocellular carcinoma each year4

HBV=hepatitis B virus; HBsAg=hepatitis B surface antigen.

*Defined as acute illness with discrete onset of symptoms and jaundice or elevated serum alanine aminotransferase (ALT) >100 IU/L.2

†Defined as unable to clear the hepatitis B virus after 6 months.1

‡Based on the 2015 Centers for Disease Control and Prevention Viral Hepatitis Surveillance report.

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 patients7-9
  • Waning serum antibody levels may compromise seroprotection over time
    – Among immunocompetent HBV vaccine responders, protection lasts 15 to 20 years7
  • Response can be compromised due to smoking history, obesity, age, chronic medical conditions, compromised immune system, or gender (male)7



NABI-HB PROVIDES PROTECTION AGAINST HEPATITIS B INFECTION WITHIN 24 HOURS OF ADMINISTRATION11,12

Guaranteed potency with Nabi-HB11

  • Each milliliter of Nabi-HB contains >312 IU/mL 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 PROTECTION11

HBIG=hepatitis immunoglobulin.

NABI-HB WAS WELL TOLERATED AND REACTIONS REPORTED WERE MILD

  • In clinical trials, the majority (92%) of reactions were reported as mild11

    Patients with mild reactions related to the administration of Nabi-HB (N=50)11

    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 globulins11

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 profile11,12

References:

  1. World Health Organization. Hepatitis B fact sheet: http://www.who.int/mediacentre/factsheets/fs204/en/. Accessed January 18, 2018.
  2. Centers for Disease Control and Prevention. Viral Hepatitis Surveillance Report, United States, 2015. https://www.cdc.gov/hepatitis/statistics/2015surveillance/pdfs/2015HepSurveillanceRpt.pdf+&cd=3&hl=en&ct=clnk&gl=us. Accessed January 18, 2018. 
  3. Centers for Disease Control and Prevention. Hepatitis B FAQs for the Public. https://www.cdc.gov/hepatitis/hbv/bfaq.htm. Accessed January 11, 2018. 
  4. Centers for Disease Control and Prevention. Epidemiology and prevention of vaccine-preventable disease: hepatitis B. https://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html. Accessed January 18, 2018. 
  5. Centers for Disease Control and Prevention. Protect your baby for life: when a pregnant woman has hepatitis B. https://www.cdc.gov/hepatitis/hbv/pdfs/hepbperinatal-protectwhenpregnant.pdf. Updated October 2010. Accessed January 18, 2018. 
  6. Centers for Disease Control and Prevention. Sharps injuries: bloodborne pathogens. https://www.cdc.gov/niosh/stopsticks/bloodborne.html. Accessed January 18, 2018. 
  7. 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. 
  8. 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.
  9. PDR: prescriber’s digital reference. Engerix (hepatitis B vaccine recombinant) drug summary: http://www.pdr.net/drug-summary/Engerix-Bhepatitis-B-vaccine—recombinant—186.5915. Accessed January 17, 2018. 
  10. Centers for Disease Control and Prevention (CDC). Adult vaccination coverage—United States, 2010. MMWR Morb Mortal Wkly Rep. 2012;61(4):66-72 
  11. Nabi-HB [Prescribing Information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; 2008. 
  12. Data on file. ADMA Biologics. 
  13. Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015;64:1-137.

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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