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 (immune globulin [human]) is indicated for prophylaxis of hepatitis A infection, prevention or modification of measles (rubeola), and passive immunization against varicella in immunosuppressed patients, and also possibly for prophylaxis of rubella in early pregnancy (for women who will not consider a therapeutic abortion).

The prophylactic value of GamaSTAN S/D is greatest when given before or soon after exposure to hepatitis A. GamaSTAN S/D is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.

GamaSTAN S/D should be given to prevent or modify measles in a susceptible person exposed fewer than 6 days previously. A susceptible person is one who has not been vaccinated and has not had measles previously. GamaSTAN S/D and measles vaccine should not be given at the same time.

Thrombosis may occur with immune globulin products, including GamaSTAN S/D. 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 S/D. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Do not give GamaSTAN S/D 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.

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

Administer GamaSTAN S/D cautiously to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

GamaSTAN S/D is made from human plasma. Because GamaSTAN S/D is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases or CJD have ever been identified for GamaSTAN S/D.

Do not administer immune globulin (human) subcutaneously or 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.

Do not perform skin tests. In most patients the intradermal injection of concentrated gamma globulin solution with its buffers causes a localized area of inflammation, which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation of a chemical nature. Misinterpretation of the results of such tests can lead the physician to withhold beneficial human immunoglobulin from a patient who is not actually allergic to this material. Although true allergic responses to human gamma globulin given in the prescribed intramuscular manner are rare, have epinephrine available for treatment of acute allergic symptoms, should they occur.

Passive transfer of antibodies may transiently impair the immune responses to live attenuated virus vaccines such as mumps, rubella, and varicella for up to 6 months, and for a year or more to measles (rubeola). Inform the immunizing physician of recent therapy with GamaSTAN S/D so that appropriate precautions can be taken. No interactions with other products are known.

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 immune globulin preparations. Anaphylaxis is more likely to occur if GamaSTAN S/D is given intravenously; therefore, GamaSTAN S/D must be administered only intramuscularly.

Please see accompanying GamaSTAN S/D full Prescribing Information for complete prescribing details.

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; 2013.

  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.