TABLE 21.
Adverse Reactions Occurring in >5% of Subjects Treated With Privigen®, Irrespective of Time of Occurrence (Chronic ITP Study)
| Adverse Reaction | Subjects (%) [N=57] | Infusions (%) [N=114] |
|---|---|---|
| Headache | 37 (64.9) | 52 (45.6) |
| Pyrexia/hyperthermia | 19 (33.3) | 21 (18.4) |
| Positive DAT | 6 (10.5) | 7 (6.1) |
| Anemia | 6 (10.5) | 6 (5.3) |
| Vomiting | 5 (8.8) | 6 (5.3) |
| Nausea | 5 (8.8) | 7 (6.1) |
| Bilirubin conjugated, increased | 5 (8.8) | 5 (4.4) |
| Bilirubin unconjugated, increased | 5 (8.8) | 5 (4.4) |
| Hyperbilirubinemia | 3 (5.3) | 3 (2.6) |
| Blood lactate dehydrogenase increased | 3 (5.3) | 3 (2.6) |
| Hematocrit decreased | 3 (5.3) | 3 (2.6) |
DAT = direct antiglobulin test (Coombs’ test).
Source: Adapted from Privigen® Prescribing Information 2011.