Patient Profiles

According to the World Health Organization (WHO), an estimated 1.4 million cases of hepatitis A occur annually.1

Jenn Landon*

Age: 37

Location: Kansas City, Kansas

Incident: Jenn has always wanted to help people. She decided her path was to become a missionary and will be traveling to Peru in 2 weeks. She also knows that she may need to be protected from specific diseases. She went to the Centers for Disease Control and Prevention (CDC) website and saw that the CDC recommends intramuscular immune globulin for prevention of hepatitis A for all unvaccinated people traveling to or working in countries with an intermediate or high level of the hepatitis A virus. She went to the hospital to make sure she received complete protection before her trip.

Diagnosis: When Jenn arrived at the hospital, the attending physician noted that the patient:

  • Is going to a developing country for approximately 3 months
  • Had not been previously vaccinated for hepatitis A

Treatment: The doctor administered the hepatitis A vaccine along with GamaSTAN® S/D [immune globulin (human)].

Outcome: Because Jenn was treated with both a vaccine and GamaSTAN S/D before she left for Peru, she was protected against hepatitis A and was able to aid those in need without concern for her own health.

Once hepatitis A is contracted, 11% to 22% of people are hospitalized.2

Jeff Pak*

Age: 32

Location: San Francisco, California

Incident: Jeff and his friends love to dine at the newest, trendiest restaurants. Recently, they dined at a very exclusive restaurant, and everyone loved the meal and had a great time. Two days later, Jeff saw on the news that numerous patrons of that same restaurant contracted hepatitis A. Worried that he could have contracted the virus, Jeff went online and found out just how serious hepatitis A is and how easily it can spread. Not wanting to endanger anyone around him, Jeff went to the hospital immediately.

Diagnosis: When Jeff arrived at the hospital, the attending physician noted that he:

  • Was potentially exposed to contaminated water and/or food
  • Had not been previously vaccinated for hepatitis A

Treatment: The doctor administered a vaccine and GamaSTAN S/D.

Outcome: Because Jeff was treated with both a vaccine and a hepatitis A immune globulin, such as GamaSTAN S/D, shortly after the potential exposure, he did not contract hepatitis A and was able to continue frequenting the latest restaurants.

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 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. World Health Organization. Hepatitis A global alert and response. World Health Organization website. http://www.who.int/csr/disease/hepatitis/whocdscsredc2007/en/index4.html#. Accessed May 11, 2016.
  2. Centers for Disease Control and Prevention. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2006;55(RR07):1-23.