WHO IS AT RISK FOR HEPATITIS B INFECTION?
Have a conversation with your healthcare provider about your risk for contracting hepatitis B if you1:
- Have been raped or sexually assaulted by a perpetrator whose hepatitis B status is positive or is a stranger/unknown person
- Had sexual contact with a partner whose hepatitis B status is positive and you do not know if you have ever received the hepatitis B vaccine
- Had sex without a condom and your partner’s hepatitis B status is positive/unknown
- Have recently shared an intravenous needle with someone whose hepatitis B status is unknown
- Had sex with a person who engages in sexual activity for payment
If you have been raped, sexually assaulted, or exposed to blood that you think
is positive for hepatitis B, you should seek medical attention right away
What is Nabi-HB?
Nabi-HB® [Hepatitis B Immune Globulin (Human)] is a single shot that your healthcare provider may give you if you have been exposed to the hepatitis B virus. Nabi-HB contains antibodies to help prevent you from getting a chronic hepatitis B infection. 1
Nabi-HB is 75% effective if administered within 2 weeks of the last sexual exposure to a person with acute hepatitis B 1
How Does Nabi-HB Work?
Nabi-HB provides immediate, protective antibodies to people who have been recently exposed to the bodily fluids of people who have hepatitis B virus, or HBV, temporarily providing them with immunity to the virus.1 These people may include:
- Sexual partners
- Infants born to mothers with hepatitis B
- Household members with hepatitis B
- Healthcare workers
What is Post-exposure Prophylaxis?
Post-exposure prophylaxis, or PEP, is a way to prevent HBV infection after a recent exposure to the virus.
Nabi-HB is administered as a post-exposure prophylaxis (PEP), to individuals with acute exposure to hepatitis B.
Due to a short window period for infection, PEP treatment must be administered in a timely manner, preferably within 24 hours of the exposure (but can be administered within 2 weeks), in order for it to be effective in protecting exposed individuals against hepatitis B virus (HBV) infection and subsequent chronic liver disease.2
In infants exposed to hepatitis B through childbirth, the CDC recommends administering a hepatitis B immune globulin (HBIG) shot, like Nabi-HB, and the first dose of the hepatitis B vaccine within 12 hours of birth.3
CDC Recommendations on PEP
The CDC recommends that all unvaccinated individuals exposed to a hepatitis B virus surface antigen (HBsAg)-positive source receive an injection of an HBIG such as Nabi-HB, along with the hepatitis B vaccine series. Once administered, an HBIG patient is protected from HBV infection for 3 to 6 months.2
About 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.4,5 About 5% of adults exposed to acute hepatitis B develop chronic HBV infection. Hepatitis B is considered chronic when it is present in the body for more than 6 months.5
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.2,4
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.4
The Centers for Disease Control and Prevention (CDC) recommends hepatitis B vaccination for adolescents, as well as unvaccinated adults at risk for HBV infection.2
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.5 These symptoms can include vomiting, fever, fatigue, nausea, abdominal pain, dark urine, joint pain, jaundice, loss of appetite, and clay-colored bowel movements.6
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.5
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).6
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. Worldwide, more than 786,000 people die from hepatitis B-related liver disease each year.6
- Nabi-HB [Prescribing Information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; 2008.
- Department of Health and Human Services, Centers for Disease Control and Prevention. Sexually Transmitted Disease Treatment Guidelines 2015: Hepatitis B. MMWR Recomm Rep. 2015;64(3):1-140.
- 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.
- 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.
- 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.
- 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.
Important Safety Information
Nabi-HB, Hepatitis B Immune Globulin (Human)
What is the most important information I should know about Nabi-HB?
Nabi-HB® is prepared from blood plasma donated by individuals with high amounts of Hepatitis B antibodies. Products, like Nabi-HB, that are made from human plasma may contain infectious agents, like viruses. Human plasma is tested for viruses and treated to kill or remove certain, known viruses. There is still the possibility that these products can transmit disease caused by known and unknown infectious agents. Talk to your healthcare provider about the risks and benefits of using Nabi-HB.
Who should not use Nabi-HB?
Do not get a Nabi-HB injection if you:
- Have had a severe allergic reaction to any human immune globulins
- Are deficient in IgA antibodies.
- Have severe thrombocytopenia (low blood platelets) or any blood clotting disorder.
What should I tell my healthcare provider before using Nabi-HB?
- If you have an IgA deficiency
- If you have severely low blood platelets or any blood clotting disorder
- If you are scheduled to take vaccinations within 3 months of taking Nabi-HB
- If you are pregnant
- If you are breastfeeding
- About all the medicines you take
What are the possible side effects of Nabi-HB?
Most side effects of Nabi-HB are mild. Side effects are grouped by how often they happen when you are treated.
Side effects are mostly local and include:
- Swelling and redness at the injection site
- Pain at the injection site
- Muscle pain
- General discomfort
- Higher than normal levels of liver enzymes
- Joint stiffness
- Lower than normal levels of white blood cells
- Higher than normal levels of creatinine
These are not all the possible side effects of Nabi-HB. Talk to your healthcare provider for any side effect that bothers you or does not go away.
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.
For more information call 1-800-458-4244.