This information is intended for U.S. audiences only.

Intended for U.S. audiences only

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What Is Hepatitis B?

Hepatitis B is a contagious virus that can cause acute or chronic inflammation of the liver. Once a person comes in contact and is infected with the hepatitis B virus (HBV) through transmission of blood or other bodily fluids, it can stay in their body for life.1,2 About 5% of adults exposed to acute hepatitis B develop chronic HBV infection.3,4 Hepatitis B is considered chronic when it is present in the body for more than 6 months.2

What Causes Hepatitis B?

Hepatitis B is caused by infection with HBV. The virus is transmitted through bodily fluids, such as blood, semen, vaginal secretions, and open wounds. Patients are often exposed to hepatitis B through unprotected sex with an infected partner or acute exposure to HBV-infected blood.1,5

An infected mother can also pass hepatitis B to her infant during childbirth, either through vaginal or cesarean delivery. Once a child becomes exposed to the virus during childbirth, the infant has a 90% chance of developing chronic hepatitis B.1

The Centers for Disease Control and Prevention (CDC) recommends hepatitis B vaccination for adolescents, as well as unvaccinated adults at risk for HBV infection.5

What Are the Symptoms of Hepatitis B?

Symptoms of acute hepatitis B can appear anywhere from 6 weeks to 6 months following exposure, with the majority of patients experiencing symptoms around 90 days.2 These symptoms can include vomiting, fever, fatigue, nausea, abdominal pain, dark urine, joint pain, jaundice, loss of appetite, and clay-colored bowel movements.4

Symptoms of chronic hepatitis B can be ongoing for some but, for most, they can often appear 20 to 30 years following exposure and typically result from the liver becoming diseased.2

How Does Hepatitis B Affect the Body?

Over time, chronic hepatitis B can lead to serious liver conditions, such as cirrhosis or hepatocellular carcinoma (HCC, also known as liver cancer).4

How Has Hepatitis B Impacted the World?

The CDC estimates that there are approximately 850,000 to 2.2 million people in the United States infected with chronic hepatitis B, with approximately 30,000 new infections reported each year. An estimated 1800 people die as a result of a chronic HBV infection. In fact, approximately 25% of patients chronically infected with hepatitis B during childhood and 15% infected after childhood will die prematurely from cirrhosis or liver cancer. And, most of these patients often remain asymptomatic until cirrhosis or end-stage liver disease manifests.4

Worldwide, more than 786,000 people die from hepatitis B–related liver disease each year.4

References:

  1. Department of Health and Human Services, Centers for Disease Control and Prevention. Protect Your Baby for Life: When a Pregnant Woman Has Hepatitis B. http://www.cdc.gov/hepatitis/HBV/PDFs/HepBPerinatal-ProtectWhenPregnant.pdf. Updated October 2010. Accessed November 7, 2017.
  2. Department of Health and Human Services, Centers for Disease Control and Prevention. Hepatitis B FAQs for the Public. https://www.cdc.gov/hepatitis/hbv/bfaq.htm. Reviewed May 23, 2016. Accessed November 7, 2017.
  3. Department of Health and Human Services, Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. The Pink Book: Course Textbook – 12th Edition Second Printing Updated March 2017. http://www.cdc.gov/vaccines/pubs/pinkbook/hepb.html. Accessed November 7, 2017.
  4. Department of Health and Human Services, Centers for Disease Control and Prevention. Hepatitis B FAQs for Health Professionals. http://www.cdc.gov/hepatitis/HBV/HBVfaq.htm#overview. Reviewed August 4, 2016. Accessed November 7, 2017.
  5. Department of Health and Human Services, Centers for Disease Control and Prevention. Sexually Transmitted Disease Treatment Guidelines 2015: Hepatitis B. MMWR Recomm Rep. 2015 June 5;64(3):1-140.

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.