View Prescribing Information (PDF)

The products discussed herein may only be dispensed with a prescription from a doctor or healthcare provider.

GamaSTAN^® S/D, Immune Globulin (Human) provides short-term pre-exposure or post-exposure protection for prevention against hepatitis A (HAV), an enterically transmitted viral infection.

Hepatitis A is a reportable disease in all states in the US. It remains a major public health problem in spite of improved hygienic and sanitary conditions. Extensive community-wide outbreaks of the disease are still prevalent in many segments of the US population.

Travelers to developing countries and people in day care environments are among those most exposed to the hepatitis A virus. Others include individuals with multiple sex partners or intravenous (IV) drug users who share needles. GamaSTAN^® S/D is convenient to use and provides short-term, temporary immunity against hepatitis A through the passive transfer of preformed antibodies.

Treatment by passively immunizing with GamaSTAN^® S/D modifies hepatitis A when given before or soon after exposure to HAV.

When administered in a timely fashion post-exposure to an infectious agent, passive immunization with GamaSTAN^® S/D can prevent or modify measles (rubeola), varicella, and rubella and may prevent serious illness from bacterial infection in patients with certain types of immune deficiency.

Recommended Use of GamaSTAN^® S/D

Travelers to developing countries are at substantial risk for acquiring hepatitis A. Tourists, military personnel, business travelers, students, and missionaries are all at risk in locations where there is high or intermediate endemicity. The prophylactic value of GamaSTAN^® S/D is greatest when given before or soon after exposure to hepatitis A.

GamaSTAN^® S/D is recommended as prophylaxis in susceptible persons (those who have not been vaccinated and have not had measles previously) exposed to measles within 6 days of contact.

GamaSTAN^® S/D provides replacement therapy of antibodies in persons with hypogammaglobulinemia and agammaglobulinemia.

For Intramuscular Administration Only.

Product attributes

			Solvent/Detergent treatment for virus inactivation (See Product Insert [PDF])
			Single dose vials for IM injection only
			Tamper-evident packaging

Contraindications, side effects, and precautions

			Use caution in persons with a history of prior systemic allergic reaction to human immune globulin products or a history of IgA deficiency
			Side effects such as local injection site reactions, urticaria, and angioedema may occur
			Administration of live virus vaccines (eg, MMR) should be deferred until approximately 3 months after immune globulin (human) administration

Disease information

Hepatitis A (HAV)
Hepatitis A is an inflammation of the liver caused by the Hepatitis A virus. The hepatitis A viral infection is found in serum, stool, and liver of an infected person. The disease is most often spread through contaminated food or water. The symptoms of hepatitis A are similar to the flu, but the skin and the eyes might become yellow because the liver is unable to function properly and filter bilirubin from the blood.

Except in rare cases, hepatitis A resolves without long-term damage to the liver.

Measles (Rubeola)
Measles is a highly contagious, acute viral infection that usually begins after a 7- to 14-day incubation period. It is characterized by fever, cough, nasal discharge, and conjunctivitis. Signs and symptoms parallel the severity of the infection. In healthy, well-nourished children, measles has a low mortality rate unless complications ensue.

Rubella (Congenital)
A pregnant woman who becomes infected with rubella (German measles) during her pregnancy may lead to congenital rubella syndrome in her unborn child. This is especially true if the infection occurs during the first 16 weeks of the pregnancy.

Congenital rubella is a viral infection that can result in fetal death or a variety of serious congenital defects, including deafness, cataracts, mental retardation, congenital heart defects, and others.

Varicella (Chickenpox)
Chickenpox is a highly infectious disease caused by the varicella-zoster virus, which results in a blister-like rash, itching, tiredness, and fever. It spreads from person to person by direct contact or through the air from an infected person's coughing or sneezing, and has a 10- to 21-day incubation period.

Hypogammaglobulinemia
Hypogammaglobulinemia is a condition in which a person has an abnormally low concentration of one or more gamma globulins in the blood and an increased risk of infection.

Agammaglobulinemia
Agammaglobulinemia is an inherited disorder characterized by very low levels of protective immunoglobulins; affected people develop repeated infections. It is a rare disorder that only affects males because it is inherited as an X-linked recessive trait (like hemophilia). The body produces very little (if any) gamma globulin (IgG) and other immunoglobulins in the bloodstream. People with this disorder are particularly susceptible to bacterial infections caused by Haemophilus influenzae, pneumococcus (Streptococcus pneumoniae), and staphylococci, as well as repeated viral infections. The upper respiratory tract, lungs, and skin are common sites of infection.

Please refer to Important Dosing and Administration Information (PDF)

For assistance or questions regarding the dosage and administration of GamaSTAN^® S/D, Immune Globulin (Human) please call (919) 412-1030.

GamaSTAN^® S/D 2 mL prefilled syringes have been distributed only in the United States.

Important Safety Information

			GamaSTAN S/D should not be given to persons with isloated 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 (e.g., MMR) should be deferred for 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.
			To view Prescribing Information for GamaSTAN S/D, please visit www.talecris-pi.info/inserts/gamastans-d.pdf.
			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.