GamaSTAN® S/D [Immune Globulin (Human)]
postexposure prophylaxis for hepatitis A

GamaSTAN® S/D Postexposure Treatment for Hepatitis A

Q&A

What is hepatitis A?

Hepatitis A is a disease that affects the liver with the hepatitis A virus (HAV).1

How is it contracted?

Hepatitis A can be contracted if someone comes into contact with an infected person's fecal matter via mouth (fecal-oral). This can happen a number of different ways: at restaurants if those handling the food haven't properly washed their hands; and drinking or eating contaminated food, water, and ice, which is why travelers to developing countries should be careful. Sexual contact and intravenous drug use are also situations that can increase risk of infection.1

What are the symptoms?

Those exposed to hepatitis A can experience symptoms quite suddenly. These symptoms include fever, tiredness, loss of appetite, nausea, abdominal discomfort, 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 who have children in daycare centers, people with multiple sex partners, or a person who uses an intravenous (IV) drug who shares needles, the CDC recommends the use of a hepatitis A immune globulin like GamaSTAN S/D in conjunction with a vaccine.2,3

What is a hepatitis A immune globulin and why isn't a vaccine enough?

A hepatitis A immune globulin is a sterile solution of immune globulin for postexposure treatment of hepatitis A. An immune globulin works much faster than a vaccine, but does not last as long. Because of the potentially life-threatening nature of hepatitis A, doctors will give you a hepatitis A immune globulin shot like GamaSTAN S/D and a vaccine to make sure you get the comprehensive care you need.4,5

Quick Facts

  • An estimated 1.4 million cases of hepatitis A occur annually6
  • When administered within 2 weeks after an exposure to the hepatitis A virus (HAV), immune globulin is 80% to 90% effective in preventing hepatitis A7
  • Once hepatitis A is contracted, 33 out of 100 people are hospitalized1
  • Convenient single-dose vials for intramuscular (IM) injection only4

GamaSTAN S/D IMPORTANT SAFETY INFORMATION


GamaSTAN S/D should not be given to persons with isolated immunoglobulin A (IgA) deficiency. Such persons have the potential for developing antibodies to IgA and could have anaphylactic reactions to subsequent administration of blood products that contain IgA.

GamaSTAN S/D should not be administered to patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.

GamaSTAN S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

Local pain and tenderness at the injection site, urticaria, and angioedema may occur. Anaphylactic reactions, although rare, have been reported following the injection of human immunoglobulin preparations. Anaphylaxis is more likely to occur if GamaSTAN S/D is given intravenously; therefore, GamaSTAN S/D must be administered only intramuscularly.

Administration of live virus vaccines (eg, MMR) should be deferred until approximately 3 months after Immune Globulin (Human) administration.

GamaSTAN S/D is made from human plasma. As with all plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease, cannot be totally eliminated. There is also the possibility that unknown infectious agents may be present in such products.

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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. Immunization Action Coalition. Hepatitis A: questions and answers http://www.immunize.org/catg.d/p4204.pdf. Accessed June 16, 2009.

  2. Hepatitis A http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepa-508.pdf. Accessed June 16, 2009.

  3. Centers for Disease Control and Prevention. FAQs for the public http://www.cdc.gov/hepatitis/A/aFAQ.htm. Accessed June 16, 2009.

  4. GamaSTAN S/D [package insert]. Research Triangle Park, NC. Grifols; 2008.

  5. Centers for Disease Control and Prevention. Principles of vaccination http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac-508.pdf. Accessed June 15, 2009.

  6. World Health Organization. Hepatitis A key facts http://www.who.int/mediacentre/factsheets/fs328/en/print.html. Accessed June 16, 2009.

  7. Centers for Disease Control and Prevention, Advisory Committee on Immunization Practices. Prevention of hepatitis A through active or passive immunization. MMWR. 2006;55(RR07):1-34.