GAMMAGARD LIQUID SubQ Administration Side Effects1
Side effects may occur with SubQ treatment. In the clinical study, infusion site reactions (e.g., mild or moderate pain, swelling, itching, redness, bruising, and/or warmth) occurred at a 2.4% rate (per infusion).a In most cases, side effects did not cause an interruption of treatment. There were no serious product-related adverse reactions.
aIn a multicenter, prospective, open-label, non-controlled study (N=49; n=47 for SubQ).
The most common side effects with SubQ infusions of GAMMAGARD LIQUID, observed in ≥5% of the study subjects in the clinical trial, are shown below.
Most Common Side Effects1
- infusion site reactions (i.e., mild or moderate pain, swelling, itching, redness, bruising, and/or warmth)
- increased heart rate
- upper abdominal pain
- increased blood pressure
- ear pain
- canker sores
- sore throat
- pain in extremity
Side effects are defined as events occurring during or within 72 hours of infusion or any causally related event occurring within the study period.
You may experience some of these side effects after the infusion. If you experience any serious side effects such as blood clots, kidney problems, serious allergic reactions (hives, swelling in the mouth, or trouble breathing) or other serious symptoms, stop the infusion immediately and contact your healthcare professional or emergency services.1
It's important to talk to your healthcare provider about what to expect with SubQ administration of GAMMAGARD LIQUID treatment. Your doctor, nurse, or other healthcare professional can help you prepare for treatment and tell you what can be done to manage possible side effects. Also, resources and support are available to help you understand your treatment.
Reference: 1. GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% [Prescribing Information]. Westlake Village, CA: Baxalta US Inc.
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