GamaSTAN®
Immune Globulin (Human)

Immediate protection


Solution of immune globulin for intramuscular administration

 

 

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.

Broad Pathogen Safety Margin:

  • Caprylate precipitation/Depth filtration
  • Caprylate incubation
  • Depth filtration
  • Column chromatography
  • Nanofiltration
  • Low pH final container incubation

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.

Related Information:

  • Mercury (thimerosal) free and latex free
  • GamaSTAN provides tamper-evident packaging
  • Vaccines can take weeks to build efficacy, which can protect for years. GamaSTAN provides immediate protection. This allows the vaccine the time needed to establish active immunity for your patients in high-risk situations, such as:
    • Travelers to developing countries, especially tourists, military personnel, business travelers, students, and missionaries
    • Children in daycare centers
    • People with multiple sex partners
    • Intravenous drug users who share needles
  • When used in combination with a vaccine, GamaSTAN offers maximum postexposure immune protection

How Supplied:

 Fill Size  NDC Number
2-mL vial 13533-335-04
10-mL vial 13533-335-12

Storage conditions:

  • Do not use after expiration date printed on the label
  • Between 2°C-8°C (36°F-46°F)
  • Do not freeze

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 hepatitis 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 download full prescribing information for GAMASTAN from the link below.

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.

Prescribing Information

  • 23 Aug, 2018

    Prescribing Information Download (111.30 Kb)

Links