Other safety alerts
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| The United States: Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions |
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The US Food and Drug Administration (FDA) announces the FDA Adverse Event Reporting System (FAERS) had received increased reporting of allergic/hypersensitivity type reactions following infusion of specific lots of Immune Globulin Intravenous (IGIV) and/or and Immune Globulin Subcutaneous (IGSC). Reports included serious adverse events, some of which were considered severe, requiring treatment with epinephrine, steroids, and/or admission to the emergency room or hospital. Though hypersensitivity and anaphylactic/anaphylactoid reactions are a known risk with immune globulin products, the increased reporting of hypersensitivity reactions to these lots presents heightened safety risks for patients. The affected products are listed below:
- Asceniv (lot number: 239825; manufacturer: ADMA Biologics)
- Bivigam (lot number: 237452; manufacturer: ADMA Biologics)
- Gammaked (lot number: B03J086043; manufacturer: Grifols for Kedrion)
- Gamunex-C (lot number: B01J100623, B03J077152, B03J079503; manufacturer: Grifols)
IGIV and IGSC are used for replacement therapy in patients with primary humoral immunodeficiency.
Please refer to the following website in FDA for details:
http://www.fda.gov/vaccines-blood-biologics/immune-globulin-intravenous-igiv-andor-immune-globulin-subcutaneous-igsc-lots-increased-reports
In Hong Kong, Gamunex-C Solution For Infusion 10% 5g/50ml (HK-63147) is a pharmaceutical product registered by Luen Cheong Hong Ltd (LCH). The product is a prescription-only medicine. As confirmed with LCH, the affected lots have not been imported into Hong Kong. Asceniv, Bivigam and Gammaked are not registered pharmaceutical products in Hong Kong. So far, the Department of Health (DH) has received 40 cases of adverse drug reaction with regard to human normal immunoglobulin, and 2 cases were related to allergy or hypersensitivity reactions. Related news was previously issued by FDA and Health Canada, and was posted on the Drug Office website on 4 Mar 2022, 11 Mar 2025, 20 Jun 2025 and 22 Aug 2025. The current product insert of the locally registered Gamunex-C already included safety warnings on the risk of hypersensitivity. The risk of hypersensitivity of human normal immunoglobulin is also documented in overseas reputable drug references such as “British National Formulary” and “Martindale: The Complete Drug Reference”. The DH will remain vigilant on any safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Saturday, Oct 25, 2025
Issued at HKT 12:00
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