Table 3.
Safety of VARIZIG (Varicella Zoster Immune Globulin [Human])
| Preferred Term | In Utero–Exposed Newborns (n = 43) | Preterm Infants (n = 80) |
|---|---|---|
| AEs | ||
| Participants, No. (%) | 7 (16) | 20 (25) |
| Total AEs, No. | 13 | 58 |
| AEs related to VARIZIG | ||
| Participants, No. (%) | 1 (2) | 1 (1) |
| Participants with related AEs, No. (%) | ||
| Seizure | … | 1 (1) |
| Varicella | 1 (2) | … |
| Serious AEs | ||
| Participants, No. (%) | 5 (12) | 7 (9) |
| Total serious AEs, No. | 5 | 20 |
| Total related serious AEs, No. | 1 | 1 |
| All related serious AEs, No. (%)a,b | ||
| Seizure | … | 1 (2) |
| Varicella | 1 (2) | … |
| Deaths, No. (%) | … | 2 (3) |
Abbreviations: AE, adverse event.
aIn the in utero–exposed population, the following serious AEs were considered unrelated to VARIZIG: pneumonia (n = 1), varicella (n = 3).
bIn the preterm infant population, the following serious AEs were considered unrelated to VARIZIG: bronchopulmonary dysplasia, pneumonia, staphylococcal sepsis, thrombocytopenia (each in 2 participants); and coagulopathy, condition aggravated, seizure, cytomegalovirus infection, disseminated intravascular coagulation, intraventricular hemorrhage, metabolic acidosis, necrotizing enterocolitis, pulmonary hemorrhage, sepsis, and urinary tract infection (each in 1 participant).