About Hepatitis A¹

Hepatitis A is an acute infectious disease of the liver caused by the hepatitis A virus (HAV). Many cases have few or no symptoms, especially in the young. The time between infection and symptoms, in those who develop them, is between 2 and 7 weeks. When symptoms occur, they typically last 8 to 12 weeks and may include nausea, jaundice, fever, and abdominal pain.

Hepatitis A Is a Serious Disease

Globally, about 3.4 million symptomatic cases and about 158 million infections occur each year^2,3
Among reported cases of hepatitis A [CDC, 2023], nearly 61% required hospitalization⁴
Older people with chronic liver disease, such as those infected with hepatitis C virus, are more likely to become seriously ill and die from hepatitis A¹

Populations at risk for hepatitis A⁵

International travelers
Men who have sex with men
Persons who use or inject drugs (ie, all those who use illegal drugs)
Persons with occupational risk for exposure
Persons who anticipate close personal contact with an international adoptee
Persons experiencing homelessness

Since 2016, most cases of hepatitis A in the United States result from person-to-person transmission during communitywide outbreaks predominantly among adults with specific risk factors such as drug use or homelessness, but also with foods that are eaten raw (eg strawberries, lettuce, raspberries) or partially cooked or undercooked (eg shrimp, scallops, oysters).¹

Postexposure Prophylaxis for Hepatitis A

GamaSTAN is indicated for prophylaxis following exposure to hepatitis A. The prophylactic value of GamaSTAN is greatest when given before or soon after exposure to hepatitis A. GamaSTAN is not indicated in persons with clinical manifestations of hepatitis A or in those exposed more than 2 weeks previously.^1,6

According to the CDC ACIP, when administered within 2 weeks after exposure to the hepatitis A virus, an IGIM, such as GamaSTAN, is 80% to 90% effective in preventing hepatitis A.⁷

IGIM should be administered to all previously unvaccinated household and sexual contacts of persons with serologically confirmed hepatitis A. Consideration should also be given to providing IGIM to persons with other types of ongoing close personal contact with a person with hepatitis A (eg, regular babysitting).¹

IGIM should be administered to all previously unvaccinated staff and attendees of child care centers or homes if (1) one or more cases of hepatitis A are recognized in children or employees, or (2) cases are recognized in 2 or more households of center attendees.¹

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Dosing Recommendations for GamaSTAN⁶

Disease State

Hepatitis A

Dosage: 0.1 mL/kg

Instruction: Administer within 2 weeks of prior exposure to hepatitis A

Measles

Dosage: 0.25 mL/kg

Instruction: Administer within 6 days of exposure

Varicella

Dosage: 0.6 mL/kg to
1.2 mL/kg

Instruction: Administer promptly if varicella-zoster immune globulin (human) is unavailable

Rubella

Dosage: 0.55 mL/kg

Instruction: Only administer to exposed pregnant women who will not consider a therapeutic abortion

Disease State	Dosage	Instruction
Hepatitis A	0.1 mL/kg	Administer within 2 weeks of prior exposure to hepatitis A
	0.1 mL/kg 0.2 mL/kg	Administer before departure to persons traveling to areas with endemic hepatitis A: 0.1 mL/kg if the length of stay will be up to 1 month 0.2 mL/kg if the length of stay will be up to 2 months; repeat every 2 months for longer stays
Measles	0.25 mL/kg	Administer within 6 days of exposure
	0.5 mL/kg	Immediately administer (maximum dose, 15 mL) to an immunocompromised child
Varicella	0.6 mL/kg to 1.2 mL/kg	Administer promptly if varicella-zoster immune globulin (human) is unavailable
Rubella	0.55 mL/kg	Only administer to exposed pregnant women who will not consider a therapeutic abortion

Important Safety Information for GamaSTAN® (immune globulin [human])

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.

References:

Nelson NP, Weng MK, Hofmeister MG, et al. Prevention of hepatitis A virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices, 2020. MMWR Recomm Rep. 2020;69(5):1-38.
Razavi H. Global epidemiology of viral hepatitis. Gastroenterol Clin North Am. 2020;49(2):179-189.
Cao G, Jing W, Liu J, Liu M. The global trends and regional differences in incidence and mortality of hepatitis A from 1990 to 2019 and implications for its prevention. Hepatol Int. 2021;15(5):1068-1082.
Widespread person-to-person outbreaks of hepatitis A across the United States. Centers for Disease Control and Prevention. Updated June 13, 2022. Accessed February 10, 2023. https://www.cdc.gov/hepatitis/outbreaks/2017March-HepatitisA.htm.
Centers for Disease Control and Prevention. Hepatitis A Questions and Answers for the Public. https://www.cdc.gov/hepatitis/hav/afaq.htm. Reviewed July 28, 2020. Accessed November 9, 2023.
GamaSTAN® (immune globulin [human]) Prescribing Information. Grifols.
Fiore AE, Wasley A, Bell BP; Advisory Committee on Immunization Practices (ACIP). Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006;55(RR-07):1-23.

About Hepatitis A1