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

GamaSTAN® S/D Postexposure Prophylaxis for Hepatitis A

Prevent the threat with GamaSTAN S/D.

According to the Advisory Committee on Immunization Practices (ACIP), when administered within 2 weeks after exposure to the hepatitis A virus (HAV), an immune globulin, such as GamaSTAN S/D, is 80%-90% effective in preventing hepatitis A.1

For more information concerning the CDC—ACIP recommendations and guidelines, visit the CDC—Advisory Committee on Immunization Practices.

Hypermunes Vaccine Visual Aid

Imminent Threat

Vaccines can take weeks to build efficacy, which can protect for years. GamaSTAN S/D provides immediate protection. This allows the vaccine the time needed to establish active immunity for your patients in high-risk situations, such as2,3:

  • Travelers to developing countries, especially tourists, military personnel, business travelers, students, and missionaries
  • Children in daycare centers
  • People with multiple sex partners
  • Intravenous (IV) drug users who share needles

Immediate Protection

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 months. When used in combination with a vaccine, GamaSTAN S/D offers maximum postexposure immune protection.4,5

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.

References:

  1. 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.

  2. Baxter D. Active and passive immunity, vaccine types, excipients and licensing. Occupational Medicine. 2007;57:552-556.

  3. Centers for Disease Control and Prevention. Hepatitis A. CDC Pink Book. http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/hepa-508.pdf. Accessed May 14, 2009.

  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 15, 2009.