doi: 10.15585/mmwr.mm6636a5.
Updated Dosing Instructions for Immune Globulin (Human) GamaSTAN S/D for Hepatitis A Virus Prophylaxis
Affiliations
- PMID:28910270
- PMCID: PMC5657912
- DOI: 10.15585/mmwr.mm6636a5
Item in Clipboard
Updated Dosing Instructions for Immune Globulin (Human) GamaSTAN S/D for Hepatitis A Virus Prophylaxis
Noele P Nelson. MMWR Morb Mortal Wkly Rep..
Display options
Format
Display options
Format
Abstract
GamaSTAN S/D (Grifols Therapeutics, Inc., Research Triangle Park, North Carolina) is a sterile, preservative-free solution of immune globulin (IG) for intramuscular administration and is used for prophylaxis against disease caused by infection with hepatitis A, measles, varicella, and rubella viruses (1). GamaSTAN S/D is the only IG product approved by the Food and Drug Administration for hepatitis A virus (HAV) prophylaxis. In July 2017, GamaSTAN S/D prescribing information was updated with changes to the dosing instructions for hepatitis A preexposure and postexposure prophylaxis indications. These changes were made because of concerns about decreased HAV immunoglobulin G antibody (anti-HAV IgG) potency, likely resulting from decreasing prevalence of previous HAV infection among plasma donors, leading to declining anti-HAV antibody levels in donor plasma (2). No changes in dosing instructions were made for measles, varicella, or rubella preexposure or postexposure prophylaxis.
Conflict of interest statement
Similar articles
- The indications and safety of polyvalent immunoglobulin for post-exposure prophylaxis of hepatitis A, rubella and measles.Young MK.Young MK.Hum Vaccin Immunother. 2019;15(9):2060-2065. doi: 10.1080/21645515.2019.1621148. Epub 2019 Jun 19.Hum Vaccin Immunother. 2019.PMID:31116633Free PMC article.Review.
- Update: Recommendations of the Advisory Committee on Immunization Practices for Use of Hepatitis A Vaccine for Postexposure Prophylaxis and for Preexposure Prophylaxis for International Travel.Nelson NP, Link-Gelles R, Hofmeister MG, Romero JR, Moore KL, Ward JW, Schillie SF.Nelson NP, et al.MMWR Morb Mortal Wkly Rep. 2018 Nov 2;67(43):1216-1220. doi: 10.15585/mmwr.mm6743a5.MMWR Morb Mortal Wkly Rep. 2018.PMID:30383742Free PMC article.
- Testing for antibody to hepatitis A to decrease the cost of hepatitis A prophylaxis with immune globulin or hepatitis A vaccines.Bryan JP, Nelson M.Bryan JP, et al.Arch Intern Med. 1994 Mar 28;154(6):663-8.Arch Intern Med. 1994.PMID:8129500
- Prevention of hepatitis A infections: guidelines for use of hepatitis A vaccine and immune globulin. American Academy of Pediatrics Committee on Infectious Diseases.[No authors listed][No authors listed]Pediatrics. 1996 Dec;98(6 Pt 1):1207-15.Pediatrics. 1996.PMID:8951284Review.
- Field effectiveness of hepatitis A vaccine and uptake of post exposure prophylaxis following a change to the Australian guidelines.Freeman E, Lawrence G, McAnulty J, Tobin S, MacIntyre CR, Torvaldsen S.Freeman E, et al.Vaccine. 2014 Sep 22;32(42):5509-13. doi: 10.1016/j.vaccine.2014.07.048. Epub 2014 Aug 8.Vaccine. 2014.PMID:25111168
Cited by
- Polyvalent Human Immune Globulin: A Prospective, Open-Label Study Assessing Anti-Hepatitis A Virus (HAV) Antibody Levels, Pharmacokinetics, and Safety in HAV-Seronegative Healthy Subjects.Kankam M, Griffin R, Price J, Michaud J, Liang W, Llorens MB, Sanz A, Vince B, Vilardell D.Kankam M, et al.Adv Ther. 2020 May;37(5):2373-2389. doi: 10.1007/s12325-020-01327-9. Epub 2020 Apr 16.Adv Ther. 2020.PMID:32301062Free PMC article.Clinical Trial.
- The indications and safety of polyvalent immunoglobulin for post-exposure prophylaxis of hepatitis A, rubella and measles.Young MK.Young MK.Hum Vaccin Immunother. 2019;15(9):2060-2065. doi: 10.1080/21645515.2019.1621148. Epub 2019 Jun 19.Hum Vaccin Immunother. 2019.PMID:31116633Free PMC article.Review.
- Update: Recommendations of the Advisory Committee on Immunization Practices for Use of Hepatitis A Vaccine for Postexposure Prophylaxis and for Preexposure Prophylaxis for International Travel.Nelson NP, Link-Gelles R, Hofmeister MG, Romero JR, Moore KL, Ward JW, Schillie SF.Nelson NP, et al.MMWR Morb Mortal Wkly Rep. 2018 Nov 2;67(43):1216-1220. doi: 10.15585/mmwr.mm6743a5.MMWR Morb Mortal Wkly Rep. 2018.PMID:30383742Free PMC article.
- Hepatitis A Virus: Essential Knowledge and a Novel Identify-Isolate-Inform Tool for Frontline Healthcare Providers.Koenig KL, Shastry S, Burns MJ.Koenig KL, et al.West J Emerg Med. 2017 Oct;18(6):1000-1007. doi: 10.5811/westjem.2017.10.35983. Epub 2017 Oct 18.West J Emerg Med. 2017.PMID:29085529Free PMC article.
- Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020.Nelson NP, Weng MK, Hofmeister MG, Moore KL, Doshani M, Kamili S, Koneru A, Haber P, Hagan L, Romero JR, Schillie S, Harris AM.Nelson NP, et al.MMWR Recomm Rep. 2020 Jul 3;69(5):1-38. doi: 10.15585/mmwr.rr6905a1.MMWR Recomm Rep. 2020.PMID:32614811Free PMC article.
References
- GamaSTAN S/D. Package insert. Research Triangle Park, NC: Grifols; 2005.https://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/...
- Important change in prescribing information immune globulin (human): GamaSTAN S/Dhttps://www.hypermunes.com/documents/24720443/24803488/Healthcare+Provid...
- Kroger AT, Duchin J, Vázquez M. General best practice guidelines for immunization. Best practices guidance of the Advisory Committee on Immunization Practices (ACIP).https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html
- 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). - PubMed
- Council of Europe. European pharmacopoeia. 8th ed. Strasbourg, France: Council of Europe; 2015.
MeSH terms
Substances
Related information
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical