title: Tolerability and safety of Octagam® (IVIG): a post-authorization safety analysis of four non-interventional phase IV trials .
abstract: OBJECTIVE
  To evaluate the tolerability and safety of Octagam®5% and 10% across all indications, ages, and treatment regimens, using data from four non-interventional post-authorization safety studies (PASS); this analysis was performed following changes in the preparation of raw material used to manufacture Octagam.
  
  
  METHODS
  All four studies included in- and out-patients prescribed Octagam for treatment of their medical condition. Physicians used case report forms to document baseline demographics, Octagam treatment details, and data on the efficacy of Octagam, and recorded all adverse drug reactions (ADRs) and other safety data.
  
  
  RESULTS
  Altogether 21,780 infusions of Octagam in 2,397 patients were included in our analysis. The most frequent indication for Octagam was secondary immunodeficiencies (SID; n = 1,368, 11,348 infusions), followed by primary immunodeficiencies (PID; n = 363; 3,923 infusions). During the individual patient observation, 83% of SID and 67% of PID patients were free of any infection. In up to 85% of all investigator assessments, Octagam was rated to have a favorable effect. In autoimmune diseases, investigators assessed Octagam as being beneficial in 70% (immune thrombocytopenia) up to 100% (Guillain-Barré syndrome), depending on the indication. The majority of patients (92%) tolerated Octagam treatment without any ADR. The overall incidence of reported ADRs was 1.0% for all infusions. The majority of ADRs were considered non-serious (93%) and mild or moderate (87%) in severity. No unexpected ADR signal was detected.
  
  
  CONCLUSIONS
  This analysis demonstrates that the changes in the preparation of raw material used to manufacture Octagam did not affect the safety profile of Octagam®5% and 10%.  *At the time of study realization.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Frenzel
authors.forename: Stefan
authors.initials: S
authors.lastname: Wietek
authors.forename: Tor-Einar
authors.initials: TE
authors.lastname: Svae
authors.forename: Anette
authors.initials: A
authors.lastname: Debes
authors.forename: Daniel
authors.initials: D
authors.lastname: Svorc
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001327:Autoimmune Diseases / Q000628:therapy; D002648:Child; D002675:Child, Preschool; D005260:Female; D020275:Guillain-Barre Syndrome / Q000628:therapy; D006801:Humans; D007136:Immunoglobulins / Q000172:deficiency; D016756:Immunoglobulins, Intravenous / Q000009:adverse effects* / Q000627:therapeutic use; D007153:Immunologic Deficiency Syndromes / Q000188:drug therapy; D007223:Infant; D007231:Infant, Newborn; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D016553:Purpura, Thrombocytopenic, Idiopathic / Q000188:drug therapy; D013921:Thrombocytopenia / Q000628:therapy; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C495669:Octagam