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Typical presentation includes: Localized redness: A circular or irregular area of pink to red discoloration, usually 1-3 cm in diameter, centered around the injection point Swelling: Mild elevation of the skin with a firm or slightly boggy texture, reflecting subcutaneous fluid accumulation and inflammation Tenderness: Discomfort ranging from mild sensitivity to moderate pain when the area is touched or pressed Pruritus: Itching sensation that may be mild to moderate, occasionally accompanied by a desire to scratch Warmth: The affected area may feel slightly warmer than surrounding skin due to increased blood flow Less commonly, patients may notice small bruises (ecchymoses) or minor bleeding at the injection site, particularly if a small blood vessel was inadvertently punctured during injection
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The label also has a new Risk Evaluation and Mitigation Strategy (REMS) program that aims to mitigate the risk of complications (such as infection, bleeding, pain) due to improper insertion and removal of the device
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