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Safety Profile
GAMMAGARD LIQUID - SC Administration

Protecting life’s moments with an established safety profile1,a

In the SC administration of GAMMAGARD LIQUID treatment clinical study:

  • Local adverse reactions (AR) reported as mild (transient discomfort that resolves spontaneously or with minimal intervention) were rash, erythema, edema, hemorrhage, and irritation. Local AEs reported as mild or moderate (limited impairment of function and resolves spontaneously or with minimal intervention and no sequelae) were pain, hematoma, pruritus, and swelling

  • The most common adverse reactions during subcutaneous (SC) treatment (observed in ≥5% of PI subjects) were infusion site (local) event, headache, fatigue, heart rate increased, pyrexia, abdominal pain upper, nausea, vomiting, asthma, blood pressure systolic increased, diarrhea, ear pain, aphthous stomatitis migraine, oropharyngeal pain, and pain extremity

aAdverse reaction is defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period

bExcluding infections

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

Adverse reactions occurring in ≥5% of subjects in the intravenous clinical studyb

No serious adverse reactions were observed during the GAMMAGARD LIQUID SC clinical study1

bExcluding infections

References: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc. 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(3):323-331.


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