Flebogamma DIF Adverse Reactions

Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia, low blood pressure and moderate low back pain may occur occasionally.
Rarely human normal immunoglobulins may cause 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, isolated cases of reversible haemolytic anaemia/haemolysis and rare cases of transient cutaneous reactions, have been observed with human normal immunoglobulin.
Increase in serum creatinine level and/or acute renal failure have been observed.
Very rarely: Thromboembolic reactions such as myocardial infarction, stroke, pulmonary embolism, deep vein thromboses.
Two multicenter clinical trials were performed, one of them in children and adults with primary immune deficiency and the second one in patients with chronic immune thrombocytopenic purpura in acute phase. Forty-six patients were included in the first trial and 41 completed the study. They were followed during 1 year of treatment at a dose of 300 - 600 mg/kg every 3 to 4 weeks. A total of 20 patients were included in the second study. Patients received a total dose of 400 mg/kg body weight for 5 consecutive days and were followed for 3 months. Therefore, a total of 66 patients have been exposed to Flebogamma 5% DIF and they have received 806 infusions. Data from both studies indicate a good tolerability of the product as incidence of adverse events was low and most of them were mild to moderate in intensity.
Of the 806 infusions administered in patients enrolled in both studies 10.8% (1-sided 95% CI upper bound = 12.9%) were associated with an adverse event suspected to be related to the product. No patients died, only 6 patients withdrew from the studies but none of them because of potentially related adverse events. Four patients experienced 8 serious adverse events that were considered not related to the study medicinal product. Pyrexia and headache were the most frequently reported adverse events potentially related to the medicinal product in both studies.
The adverse drug reactions reported in the 2 trials by at least the 5% of the patients are summarised and categorised according to the MedDRA system organ class in the table as follows: Frequency has been determined using the following criteria: very common: ≥1/10; common: ≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000, not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing of seriousness. (See Table 2.)

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