The tolerability and safety of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% were evaluated in 44 patients with MMN who received a total of 983 infusions of GAMMAGARD LIQUID1

  • The percentage of infusions for which patients on GAMMAGARD LIQUID experienced a headache was 2.9% compared with 2.3% of infusions for patients on placebo1
  • Two serious ARs in the clinical trial for MMN, each impacting one subject, were pulmonary embolism and blurred vision, both of which were judged to be treatment related1
  • In the study, among the 317 non-serious AEs, 176 were considered ARs. Of these, 126 were mild, 37 were moderate, and 13 were severe1
    • Mild: transient discomfort that resolves spontaneously or with minimal intervention
    • Moderate: limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae
    • Severe: marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae
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References:

  1. Gammagard Liquid [Immune Globulin Infusion (Human)] 10% [package insert]. Westlake Village, CA: Baxter Healthcare Corporation.
  2. Data on file, Baxter Healthcare Corporation. 2011.

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Selected Important Safety Information about GAMMAGARD LIQUID
  • GAMMAGARD LIQUID can cause decreased kidney function or kidney failure, blood clots in the heart, brain, lungs or elsewhere in the body. Call your healthcare professional or go to your emergency department right away if you have: Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem. Pain, swelling, warmth, redness, or a lump in your legs or arms. These could be signs of a blood clot.
  • Do not take GAMMAGARD LIQUID if you have a known history of a severe allergic reaction to IgG or other blood products.