Adverse reactions such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure, and moderate back pain may occur occasionally in connection with intravenous administration of human immunoglobulin.
Rarely human immunoglobulin may cause hypersensitivity reactions with a sudden fall in blood pressure and, in isolated cases, anaphylactic shock, even when the patient has shown no hypersensitivity to previous administration.
Cases of reversible aseptic meningitis and rare cases of transient cutaneous reactions have been observed with human normal immunoglobulin.
Reversible haemolytic reactions have been observed in patients, especially those with blood groups A, B, and AB (non-O-blood groups) in immunomodulatory treatment. Rarely, haemolytic anaemia requiring transfusion may develop after high dose IVIg treatment (see Precautions).
Increase in serum creatinine levels and/or acute renal failure have been observed.
Very rarely: transfusion related acute lung injury and thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, and deep vein thrombosis have occurred.
Tabulated list of adverse reactions: Seven clinical studies were performed with Privigen, which included patients with PID, ITP and CIDP patients, respectively. In the PID pivotal study, 80 patients were enrolled and treated with Privigen. Of these, 72 completed the 12 months of treatment. In the PID extension study, 55 patients were enrolled and treated with Privigen. Another clinical study included 11 PID patients in Japan.
Two ITP studies were performed with 57 patients each. Two CIDP studies were performed with 28 and 207 patients, respectively.
Most adverse drug reactions (ADRs) observed in the seven clinical studies were mild to moderate in nature.
The following table shows an overview of the ADRs in the seven studies, categorized according to MedDRA System Organ Class (SOC and Preferred Term Level (PT)) and frequency. Frequencies per infusion were evaluated according to the following conventions: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100). For spontaneous post-marketing ADRs, the reporting frequency is categorized as unknown.
Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. (See Table 3.)
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Paediatric Population: In Privigen clinical studies with paediatric patients, the frequency, nature and severity of adverse reactions did not differ between children and adults. In post-marketing reports, it is observed that the proportion of haemolysis cases to all case reports occurring in children is slightly higher than in adults. Refer to Precautions for details on risk factors and monitoring recommendations.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.