ADVERSE REACTIONS
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, requiring dialysis has been observed. Types of severe renal adverse events that have been seen following IGIV therapy include: acute renal failure, acute tubular necrosis, proximal tubular nephropathy and osmotic nephrosis (30-35,50,60-62).Inflammatory adverse reactions have been described in agammoglobulinemic 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 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 as follows: 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. Immediate anaphylactoid and hypersensitivity reactions due to previous sensitization of the recipient to certain antigens, most commonly IgA, may be observed in exceptional cases, described under CONTRAINDICATIONS (15,16,51). In patients with ITP, who receive higher doses (0.4 g/kg/day or greater), 2.9% of infusions may result in adverse reactions (20). Headache, generally mild, is the most common symptom noted, occurring during or following 2% of infusions. A few cases of usually mild hemolysis have been reported after
infusion of intravenous immunoglobulin products (52,53). These were attributed to transferral of blood group (e.g., anti-D) antibodies (54,55).
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REPORTS OF SUSPECTED CARIMUNE NF SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Carimune NF. The information is not vetted and should not be considered as verified clinical evidence.
Possible Carimune NF side effects / adverse reactions in 35 year old female
Reported by a physician from United States on 2012-02-21
Patient: 35 year old female
Reactions: Caesarean Section, Maternal Exposure During Pregnancy, Hypertension, PRE-Eclampsia, Hepatic Enzyme Increased
Adverse event resulted in: hospitalization
Suspect drug(s):
Carimune NF
Possible Carimune NF side effects / adverse reactions in 70 year old female
Reported by a pharmacist from United States on 2012-04-11
Patient: 70 year old female weighing 80.3 kg (176.6 pounds)
Reactions: Malaise, Vomiting, Nausea, Dehydration
Adverse event resulted in: hospitalization
Suspect drug(s):
Carimune NF
Other drugs received by patient: Forteo
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