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

GamaSTAN® S/D Postexposure Prophylaxis for Hepatitis A

Hepatitis A Quick Facts

  • According to the World Health Organization (WHO), an estimated 1.4 million cases of hepatitis A occur annually1
  • Once hepatitis A is contracted, 33 out of 100 people are hospitalized2
  • According to the Advisory Committee on Immunization Practices (ACIP), when administered within 2 weeks after an exposure to the hepatitis A virus (HAV), immune globulin is 80%-90% effective in preventing hepatitis A3

GamaSTAN S/D Quick Facts

  • GamaSTAN S/D is mercury (thimerosal) free and latex free4
  • Only GamaSTAN S/D has FDA labeling for removal of pathogenic prions that may cause TSEs* in humans
  • GamaSTAN S/D provides tamper-evident packaging
  • GamaSTAN S/D is a sterile solution of immune globulin for intramuscular administration for postexposure prophylaxis for hepatitis A, providing rapid immune protection for up to 3 months5,6
  • Convenient single-dose vials for 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.

For full Prescribing Information, click here.

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.

*Human TSEs (transmissible spongiform encephalopathies) are a group of neurodegenerative diseases related to mad cow disease.

References:

  1. Hepatitis A. World Health Organization, DCDSR. WHO/CDS/CSR/EDC/2000.7:1-39. http://www.who.int/csr/disease/hepatitis/whocdscsredc2007/en/. Accessed June 17, 2009.

  2. Immunization Action Coalition. Hepatitis A questions and answers. Accessed June 17, 2009.

  3. Prevention of hepatitis A through active or passive immunization. ACIP, CDC. MMWR. 2006;55(RR-07):1-23.

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

  5. Centers for Disease Control and Prevention. FAQs for Health Professionals. http://www.cdc.gov/hepatitis/HAV/HAVfaq.htm#general. Accessed June 17, 2009.

  6. Principles of vaccination. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/prinvac-508.pdf. Accessed May 14, 2009.