Treating With GamaSTAN1

GamaSTAN is a human immune globulin where the polyclonal antibody contained within is a passive immunizing agent to neutralize viruses, such as hepatitis A and measles viruses, to prevent or ameliorate disease.

GamaSTAN is indicated for use in the following situations:

  1. Postexposure prophylaxis for hepatitis A infection
    - GamaSTAN is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously
  2. Prevention or modification of measles (rubeola) in susceptible persons exposed fewer than 6 days previously; a susceptible person is one who has not been vaccinated and has not had measles previously
  3. Passive immunization in immunocompromised patients to protect against varicella if varicella-zoster immune globulin (human) is not available
  4. May benefit women who have been exposed to rubella in the first trimester of pregnancy and who will not consider a therapeutic abortion

Trusted Dependability

  • Established history—more than 45 years of consistent supply and product support
  • Mercury (thimerosal) and latex free
  • US Food and Drug Administration (FDA) labeling for capacity to remove pathogenic prions
  • Tamper-evident packaging
  • 24-month shelf life

Clinical Efficacy

Peak levels of immunoglobulin G (IgG) are obtained approximately 2 days after intramuscular (IM) injection of GamaSTAN. The half-life of IgG in the circulation of individuals with normal IgG levels is 23 days.1

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.

Safety Is a Priority1

Manufacturing Process
Pathogen Safety

The following GamaSTAN manufacturing steps contribute to inactivation and/or removal capacity:

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

The caprylate/chromatography manufacturing process was also investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed by the caprylate/chromatography manufacturing process.

GamaSTAN is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the vCJD agent, and, theoretically, the CJD agent.

 

Traceability and Transparency of Information

Grifols' manufacturing process has a comprehensive computer system called PediGri® that ensures full traceability from every donation.

  • Each plasma unit is coded and computer-traced from the start of the process until the units are transformed into a final product
  • Users can access the donation number and the viral screening conducted at the origin of the donation with the product lot number
    • Specific information is also available, including the total number of plasma units, the total volume of plasma, the certificate of analysis showing the plasma origin viral screening, and biochemical characteristics of the final product

For immediate, easy, and convenient access to all the information on the origin and quality of Grifols' plasma derivatives, visit www.pedigri.grifols.com.

Dosing Recommendations for GamaSTAN1

Coding Information

Download an informational guide about the Hypermunes portfolio. 

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.


Reference:

  1. GamaSTAN® (immune globulin [human]) Prescribing Information. Grifols.