ZIRABEV® Safety Information
ZIRABEV® HAS A SAFETY PROFILE SIMILAR TO THAT OF REFERENCE BEVACIZUMAB2
No significant differences in adverse events of special interest2
Adverse events of special interest, all causalities (safety population)3
- The incidence of treatment-emergent adverse events for all categories was similar across treatment groups4
- No new safety signals were identified with ZIRABEV compared with the known adverse event profile of Reference Bevacizumab2
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC
- Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies
- Pregnancy (see section 4.6 of the SmPC)
Abbreviations: GI=gastrointestinal. n=count. SmPC=summary of product characteristics.
1. ZIRABEV® (bevacizumab) summary of product characteristics.
2. Reinmuth N, Bryl M, Bondarenko I, et al. BioDrugs. 2019;33(5):555-570.
3. Reinmuth N, Bryl M, Bondarenko I, et al. Supplementary Material BioDrugs. doi:10.1007/s40259-019-00363-4.
4. Data on file. Pfizer Inc., New York, NY. 2018.
PP-BIO-IRL-0130. Preparation Date: April 2021.