GAMMAGARD LIQUID for
Subcutaneous (SubQ) Administration
Sustained Protection Against Infection1
SubQ administration of GAMMAGARD LIQUID treatment has been shown to be effective in a clinical study of 49 adult and pediatric PI subjects. Prior to receiving GAMMAGARD LIQUID SubQ, subjects were treated with IV Ig* every 3 or 4 weeks for 12 weeks.1
- Annual rate of less than 0.1 validated acute serious bacterial infections per subject-year†
- 3 cases of serious validated bacterial pneumonia; none required hospitalization to treat the infection
- No hospitalizations secondary to any infections over the course of the clinical study
†The upper 99% confidence limit of 0.133 is lower than the minimal goal of achieving a rate of >1 bacterial infection per subject-year.
Demonstrated Tolerability in the Clinical Study1
In the GAMMAGARD LIQUID clinical study for SubQ administration, there was demonstrated tolerability.
Please see below for Detailed Important Risk Information.
|of infusions were completed without reducing the infusion rate or stopping the infusion due to
side effects or tolerability issues.‡
‡The safety of GAMMAGARD LIQUID in SC infusions was evaluated in 47 subjects during all SC treatment periods.
GAMMAGARD LIQUID treatment is formulated with1:
- Added Sugars1
- Added Sodium1
- Added Preservatives1
- Stabilized and buffered with glycine1 for those patients in whom additives may be a concern
- The packaging is not made with natural rubber latex1
Reference: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.
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