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Demonstrated Tolerability
GAMMAGARD LIQUID - SC Administration

Protecting life's moments with demonstrated tolerability1,a

In the subcutaneous (SC) administration of GAMMAGARD LIQUID clinical study:

 

  • 17% (n=8) of subjects had a local AR at first infusion
  • This decreased to 2.2% (n=1) of subjects during the second and third infusions. This ranged from 0% to 8.7% (n=0 to 4) during the remainder of the first year
  • No local ARs were reported for the remainder of the study (weeks 53 to 68)

aThe safety of GAMMAGARD LIQUID in SC infusions was evaluated in 47 subjects.
bDuring all SC treatment periods.

 

Established tolerability profile of local ARs at first infusion, which declined with subsequent infusions1


17% (n=8) of subjects had a local AR at first infusion

This decreased to 2.2% (n=1) of subjects during the second and third infusions

This ranged from 0% to 8.7% (n=0 to 4) during the remainder of the first year of SC administration

No local ARs were reported for the remainder of the study (weeks 53-68)


 
(340/348) of non-serious adverse reactions (ARs) reported in this study were considered mild (228) or moderate (112).
(The remaining 2% [8/348] were rated severe)
 
of non-serious ARs were mild (n=228)
Mild ARs were defined as transient discomfort that resolves spontaneously or with minimal intervention
 
of non-serious ARS were moderate (n=112)
Moderate ARs were defined as limited impairment of function and resolves spontaneously or with minimal intervention with no sequelae
 
of non-serious ARs were severe (n=8)
Severe ARs were defined as marked impairment of function or can lead to temporary inability to resume normal life pattern; requires prolonged intervention or results in sequelae

 

Subject to Discontinuations in the Clinical Study2

  • One subject withdrew from the study after 10 treatments with GAMMAGARD LIQUID subcutaneous infusion (2.5 months) due to increased fatigue and malaise

 

Safety in terms of reported adverse events was monitored throughout the SC administration of the GAMMAGARD LIQUID study as described below2

  • Depending on whether infusions were administered in hospital or by the subject/parent at home, adverse events during infusion (including local reactions) were documented either by the investigator or a home care nurse.
  • Adverse events were followed up by telephone 72 hours after completion of infusion.
  • All post-infusion adverse events were recorded by the subject in a diary and transcribed to the case report form at regular intervals at the scheduled clinic visits.
  • Grading of all adverse events (including injection site adverse events) for severity was performed by the investigator based on patient/event outcome or action criteria.

Definitions

  • Temporally associated adverse events were defined as adverse events that occurred during infusion or within 72 hours after completion of an infusion.
  • Adverse Reactions are defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period.1

References: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxter Healthcare Corporation. April 2014. 2. Wasserman RL, Melamed I, Kobrynski L, et al. Efficacy, safety, and pharmacokinetics of a 10% liquid immune globulin preparation (GAMMAGARD LIQUID, 10%) administered subcutaneously in subjects with primary immunodeficiency disease. J Clin Immunol. 2011;31:323-331.


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