Postexposure Prophylaxis for Hepatitis A

Prevent the threat with GamaSTAN® (immune globulin [human]) postexposure prophylaxis for hepatitis A.

Hepatitis A is primarily spread 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 intravenous use can increase risk of infection as well.1

According to the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), when administered within 2 weeks after exposure to the hepatitis A virus, an intramuscular immune globulin, such as GamaSTAN, is 80% to 90% effective in preventing hepatitis A.2

For more information concerning the CDC ACIP recommendations and guidelines, visit the CDC ACIP website.

Immediate Protection

GamaSTAN is a sterile solution of immune globulin for intramuscular administration for postexposure prophylaxis for hepatitis A, providing rapid immune protection for up to 3 months.3,4

Safety Is a Priority3

  • GamaSTAN is mercury (thimerosal) free and latex free
  • GamaSTAN has Food and Drug Administration (FDA) labeling for capacity to remove pathogenic prions that may cause transmissible spongiform encephalopathies in humans
    • Studies of the GamaSTAN manufacturing process demonstrated that TSE clearance is achieved during the Pooled Plasma to Effluent III Fraction Process (6.7 log10). These studies provide reasonable assurance that low levels of Creutzfeldt-Jakob disease (CJD) or variant CJD agent infectivity, if present in the starting material, would be removed
  • GamaSTAN provides tamper-evident packaging
  • 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

Dosing Recommendations3*

GamaSTAN Dosing Recommendations

Product Information3

GamaSTAN Product Information

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. GamaSTAN® (immune globulin [human]) Prescribing Information. Grifols.
  4. Centers for Disease Control and Prevention. Hepatitis A questions and answers for health professionals. http://www.cdc.gov/hepatitis/hav/havfaq.htm. Updated July 27, 2018. Accessed August 8, 2018.