Updated dosing instructions for immune globulin (human) gamaSTAN S/D for hepatitis a virus prophylaxis.
Following are the updated recommended doses of GamaSTAN S/D for hepatitis A preexposure and postexposure prophylaxis (2).
Preexposure Prophylaxis in Persons Who Plan to Travel in Areas with High or Intermediate Hepatitis A Endemicity
The recommended dosages of GamaSTAN S/D, which vary according to planned duration of travel are as follows (Table):
* Up to 1 month: 0.1 mL/kg
* Up to 2 months: 0.2 mL/kg
* 2 months or longer: repeat dose of 0.2 mL/kg every 2 months.
Postexposure Prophylaxis of Household and Institutional Hepatitis A Case Contacts
The recommended dosage of GamaSTAN S/D is 0.1 mL/kg (Table). There is no maximum dosage of GamaSTAN S/D for hepatitis A prophylaxis (1).
The effect of IG preparations on the response to certain live-virus vaccines is unknown, but antibodies in GamaSTAN S/D might interfere with live-virus vaccines such as measles, mumps, and rubella (MMR) vaccine and varicella vaccine (1,3). The recommendations for the timing of administration of GamaSTAN S/D with live-virus vaccines has not changed (1,3). The Advisory Committee on Immunization Practices (ACIP) recommends that MMR and varicella vaccines should be administered at least 2 weeks before or at least 3 months after the administration of IG preparations (1). If an IG preparation must be administered less than 2 weeks after the administration of MMR or varicella vaccine, the patient should be revaccinated no sooner than 3 months after receipt of the IG preparation.
The absolute lower limit of anti-HAV IgG required to prevent HAV infection has not been defined; however, 10 mIU/mL is considered to be the minimum protective level for HAV prophylaxis (1,4). The minimum anti-HAV IgG potency specified by the European Pharmacopoeia for intramuscular IG preparations indicated for HAV prophylaxis is >100 IU/mL (5). A recent study showed that only two of nine tested lots of commercially available IG preparations manufactured in the United States, Europe, and Asia had anti-HAV IgG potency of 100 IU/mL (6). In addition, anti-HAV IgG decay models indicate that only five of nine lots of IG dosed at 0.02 mL/kg achieved postabsorption plasma anti-HAV IgG levels above the minimum protective level of 10 mIU/mL (6). The decay model also showed that none of the tested IG lots maintained the proposed minimal protective anti-HAV IgG level of 10 mIU/mL for 3 months (6).
Indications for the use of IG are based on ACIP recommendations published in 2007 for prevention of hepatitis A infection after exposure to HAV and in international travelers (7).
Preexposure Prophylaxis for International Travel
Hepatitis A vaccine at the age-appropriate dose is preferred to IG. For travel that will begin in [less than or equal to] 2 weeks to countries with high or intermediate hepatitis A endemicity, older adults, immuno-compromised persons, and persons with chronic liver disease or other chronic medical conditions may receive IG simultaneously with hepatitis A vaccine at a separate anatomic injection site. Travelers who elect not to receive hepatitis A vaccine, who are aged <12 months, or who are allergic to a component of hepatitis A vaccine should receive a single dose of IG before travel (7).
IG should be used for children aged <12 months, immuno-compromised persons, persons who have chronic liver disease, and persons for whom vaccine is contraindicated. IG is also preferred over hepatitis A vaccine for persons aged >40 years; however, vaccine may be used if IG cannot be obtained (7).
Conflict of Interest
No conflicts of interest were reported.
(1.) GamaSTAN S/D. Package insert. Research Triangle Park, NC: Grifols; 2005. https://www.fda.gov/downloads/BiologicsBloodVaccines/ BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/ FractionatedPlasmaProducts/UCM371376.pdf
(2.) Important change in prescribing information immune globulin (human): GamaSTAN S/D https://www.hypermunes.com/ documents/24720443/24803488/Healthcare+Provider+Letter+Gam aSTAN+SD+Revised+Dosage+July+7+2017_with+LIT+C0DE.pdf/ b831e517-9d0b-472c-b5b5-719f5bb5e47c
(3.) Kroger AT, Duchin J, Vazquez M. General best practice guidelines for immunization. Best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/aciprecs/general-recs/index.html
(4.) Fiore AE, Wasley A, Bell BP. Prevention of hepatitis A through active or passive immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2006;55(No. RR-7).
(5.) Council of Europe. European pharmacopoeia. 8th ed. Strasbourg, France: Council of Europe; 2015.
(6.) Tejada-Strop A, Costafreda MI, Dimitrova Z, Kaplan GG, Teo CG. Evaluation of potencies of immune globulin products against hepatitis A. JAMA Intern Med 2017;177:430-2. https://doi.org/10.1001/ jamainternmed.2016.9057
(7.) CDC. Update: prevention of hepatitis A after exposure to hepatitis A virus and in international travelers. Updated recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2007;56:1080-4.
Noele P. Nelson, MD 
 Division of Viral Hepatitis, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, CDC.
Corresponding author: Noele P. Nelson, email@example.com, 404-718-8576.
TABLE. Indications and updated dosage recommendations for GamaSTAN S/D human immune globulin for preexposure and postexposure prophylaxis against hepatitis A infection Indication Updated dosage recommendation Preexposure prophylaxis Up to 1 month of travel 0.1 mL/kg Up to 2 months of travel 0.2 mL/kg 2 months of travel or longer 0.2 mL/kg (repeat every 2 months) Postexposure prophylaxis 0.1 mL/kg
|Printer friendly Cite/link Email Feedback|
|Author:||Nelson, Noele P.|
|Publication:||Morbidity and Mortality Weekly Report|
|Date:||Sep 15, 2017|
|Previous Article:||Occupational animal exposure among persons with campylobacteriosis and cryptosporidiosis--Nebraska, 2005-2015.|
|Next Article:||Vibrio cholerae serogroup 01, serotype Inaba--Minnesota, August 2016.|