Postexposure Treatment for Hepatitis A

Q&A

What is hepatitis A?
Hepatitis A is a disease that affects the liver and is caused by the hepatitis A virus.

How is it contracted?
Hepatitis A is spread primarily when an uninfected and unvaccinated person ingests food or water that is contaminated with the feces of an infected person. This can happen a number of ways, such as if those handling the food at a restaurant haven't properly washed their hands, or by drinking or eating contaminated food, water, and ice in areas with poor sanitation, which is why travelers to developing countries should be careful. Sexual contact with an infected person and illegal drug use can increase risk of infection as well.1

What are the symptoms?
Those exposed to hepatitis A may experience symptoms 2 to 6 weeks after exposure, and symptoms may develop over a period of several days. Some people do not have any symptoms. Symptoms include fever, tiredness, loss of appetite, nausea, vomiting, abdominal discomfort, light-colored stool, dark urine, and jaundice (yellowing of the skin and eyes).1

How can I prevent hepatitis A?
The key to prevention is proper vaccination. The CDC recommends receiving the hepatitis A vaccine as early as possible. For those in high-risk situations, such as those traveling to developing countries (especially tourists, military personnel, business travelers, students, and missionaries), people with multiple sex partners, or people who use illegal drugs, the CDC recommends the use of a hepatitis A immune globulin like GamaSTAN in conjunction with a vaccine.

What is an immune globulin, and why isn't a vaccine enough?
An intramuscular immune globulin is a sterile solution of immune globulin for postexposure treatment of hepatitis A. An intramuscular immune globulin works much faster than a vaccine but does not last as long. Doctors will give you a hepatitis A immune globulin shot such as GamaSTAN and a vaccine to make sure you get the comprehensive care you need.2,3

QUICK FACTS

  • An estimated 1.4 million cases of hepatitis A occur annually worldwide4
  • When administered within 2 weeks after an exposure to the hepatitis A virus, an intramuscular immune globulin is 80% to 90% effective in preventing hepatitis A2

INDICATIONS AND USAGE

GAMASTAN (immune globulin [human]) is indicated for prophylaxis following exposure to hepatitis A infection, prevention or modification of measles in susceptible persons exposed fewer than 6 days previously, modification of varicella, and modification of rubella in exposed women who will not consider a therapeutic abortion. 
 
Limitations of Use
 
GAMASTAN is not indicated for routine prophylaxis or treatment of viral hepapitis type B, rubella, poliomyelitis, mumps, or varicella.
 
IMPORTANT SAFETY INFORMATION
 
Thrombosis may occur with immune globulin products, including GAMASTAN. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
 
For patients at risk of thrombosis, do not exceed the recommended dose of GAMASTAN. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
 
GAMASTAN is contraindicated in patients who have had anaphylactic or severe systemic hypersensitivity reactions to immune globulin (human) and in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.
 
Administer GAMASTAN cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations. Have epinephrine available for treatment of acute allergic symptoms, should they occur.
 
Inject intramuscularly only. Do not administer GAMASTAN intravenously because of the potential for serious reactions (eg, renal dysfunction/failure/hemolysis, transfusion-related acute lung injury [TRALI]). Do not inject into a blood vessel.
 
GAMASTAN 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. 
 
The most common adverse reaction reported for GAMASTAN S/D during post-approval use was fatigue.
 
Antibodies in GAMASTAN may interfere with the response to live virus vaccines such as measles, mumps, polio, rubella, and varicella. Defer live vaccine administration for up to 6 months after GAMASTAN administration.
 

Please see full Prescribing Information for GAMASTAN.

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.


References:

  1. Centers for Disease Control and Prevention (CDC). Hepatitis A questions and answers for the public. CDC website. http://www.cdc.gov/hepatitis/hav/afaq.htm. Updated April 20, 2018. Accessed August 8, 2018.
  2. Fiore AE, Wasley A, Bell BP; Advisory Committee on Immunization Practices (ACIP). Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(RR07):1-23.
  3. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occup Med. 2007;57:552-556.
  4. World Health Organization (WHO). Hepatitis A fact sheet. WHO website. http://www.wpro.who.int/mediacentre/factsheets/fs_20120219_hepa/en/. Upated July 7, 2017. Accessed August 8, 2018.
  5. GamaSTAN® (immune globulin [human]) Prescribing Information. Grifols.