Tolerability and safety of the intravenous immunoglobulin Octagam: a 10-year prospective observational study.

PURPOSE Following the approval of Octagam in 1995, an open prospective observational cohort study has been initiated to observe the tolerability of the intravenous immunoglobulin Octagam. This study aimed to evaluate the long-term safety profile of Octagam in daily use in the treatment of various primary (PID) and secondary (SID) immunodeficiencies and autoimmune diseases (AID). METHODS Within a time period of 10 years, data were collected in 310 study sites. The treating physicians documented patient characteristics, treatment parameters and the occurrence of an adverse drug reaction (ADR) by using detailed case record forms (CRF). RESULTS A total of 6357 patients of all ages received 92 958 infusions of Octagam. ADR occurred in 4.2% of the patients and in 0.35% of all infusions. Most of them (94.8%) were classified as nonserious, the majority (90.2%) were of mild or moderate intensity. The ADR frequency differed slightly between the indication groups, for example in PID patients ADR occurred in 8.3% of patients and 0.5% of infusions, in SID patients in 5.0% of patients and 0.62% of infusions. Rigors were reported most frequently, followed by fever, headache, nausea and flush. The ADR symptoms differed between the indication groups, rigors were predominantly described in SID patients, headache in PID and AID patients including idiopathic thrombocytopenic purpura (ITP). A relation between the ADR frequency and elevated infusion rates or high dosages was not detected. CONCLUSIONS This unique 10-year observational study demonstrates that Octagam is well tolerated in routine clinical use with an overall ADR frequency of 0.35%.