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 they recommend 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 she:

  • 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® (immune globulin [human]).

Outcome: Because Jenn was treated with both a vaccine and GamaSTAN 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.

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

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. 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. 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.