Immunorel Adverse Reactions

Adverse reactions such as pain, headache and chills may be seen in patients with immunodeficiency.
Inflammatory adverse reactions have been described in agammaglobulinemic and hypogammaglobulinemic patients who have never received immunoglobulin substitution therapy before or in patients whose time from last treatment is greater than 8 weeks and whose initial infusion rate exceeds 20 drops (1 mL) per minute. This occurs in approximately 10% of such cases. Such reactions may also be observed in some patients during chronic substitution therapy.
These reactions, which generally become apparent only 30 minutes to 1 hour after the beginning of the infusion, are flushing of the face, feelings of tightness in the chest, chills, fever, dizziness, nausea, diaphoresis, and hypotension. In such cases the infusion should be temporarily stopped until the symptoms have subsided.
Immunoglobulin Normal, Human (ImmunoRel) although contains small amounts of IgA ≤ 80 mg/L, it is not indicated in patients with IgA deficiencies. In such cases there is a fair amount of risk of anaphylactic reactions to the product.
Increases in creatinine and blood urea nitrogen (BUN) have been observed as soon as one to two days following infusion. Progression to oliguria or anuria may require dialysis. Severe occasional renal adverse events that have been reported following IVIG therapy include: acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis.
Very rarely, mild haemolysis have been reported after infusion of intravenous immunoglobulin products. These were attributed to transferals of blood group e.g., anti-D antibodies.