Are there adverse reactions or side effects that are common with Vivaglobin®?
In the US and Canada clinical study, SCIg was evaluated in 65 subjects diagnosed with PI. In clinical trials, the most frequent adverse event was injection-site reaction, consisting of mild or moderate swelling, redness, and itching. No serious local site reactions were observed, and reactions tended to decrease substantially after repeated use. Reactions similar to those reported with administration of other immune globulin products may also occur. Rarely, immediate anaphylactoid and hypersensitivity reactions may occur. Other adverse events irrespective of causality included headache, gastrointestinal disorder, fever, nausea, sore throat, and rash. As with all immune globulin (Ig) products, patients receiving Ig therapy for the first time, receiving a new product, or not having received Ig therapy within the preceding eight weeks may be at risk for developing reactions including fever, chills, nausea, and vomiting. On rare occasions, these reactions may lead to shock. Such patients s
