In the pivotal clinical trial in 44 adult patients with MMN, study subjects were on a regimen of Immunoglobulin (existing maintenance dose ranging from 0.5 to 2.0 grams/kg/month) prior to enrollment.

The pivotal clinical trial was an enrichment design, therefore the results cannot be generalized to naïve patients.

aAs initial dose was not studied, dosing guidance is available from existing EFNS/PNS guidelines.
bEach 12-week study part comprised 3, 4, or, 6 infusion cycles, depending on treatment intervals (2, 3, or 4 weeks). In the pivotal clinical trial, the dose ranged between 0.5 to 2.4 grams/kg/month2.

EFNS=European Federation of Neurological Societies; PNS=Peripheral Nerve Society.

GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% is available in 1, 2.5, 5, 10, 20 and 30g vial size1

The dose may need to be adjusted to achieve the desired clinical response. While receiving GAMMAGARD LIQUID, 9% of subjects in the clinical study experienced neurological decompensation that required an increase in dose. In order to avoid worsening of muscle weakness in patients, dose adjustment may be necessary.1

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.