Uptick in Infusion Reactions with Gamunex-C

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Wed, 06/11/2025 - 21:06

Paul MacDowell

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Last seen: 4 days 5 hours ago

Joined: 07/13/2017 - 22:23

Uptick in Infusion Reactions with Gamunex-C

Hi all-
We have had a recent uptick in infusion reactions with Gamunex-C IVIG product at our organization and have reported to FDA MedWatch. I wanted to share with this group and see if others are experiencing similar reporting at their organization. Within a month time span, we have approx. double the amount reports we would typically see in a 12 month span. In reviewing reactions, the most common lot number involved in reactions seems to be 20gm vial size Lot B01J093362.

Reactions are occurring in patients previously tolerating many prior infusions. Some patients received pre-meds and have still experienced reaction. Most common symptoms in these cases are rash and itching responsive to antihistamines.

Thanks,
Paul

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