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Safety
Manufacturing process
Adverse reactions1
| MedDRA Standard Systems Organ Clas | Adverse Reaction | Frequency |
|---|---|---|
| Blood and lymphatic system disorders | FVIII inhibition |
Uncommon (PTPs) Very common (PUPs) |
| VWF inhibition | Not known | |
| Immune system disorders |
Hypersensitivity (including tachycardia, chest pain, chest discomfort and back pain) |
Common |
| Nervous system disorders | Dysgeusia | Uncommon |
| Vascular disorders | Thromboembolic event | Uncommon |
| General disorders and administration site conditions | Pyrexia | Common |
| Headache | Very Common | |
| Investigations | Liver function test abnormal | Uncommon |
PTPs = previously treated patients.
PUPs = previously-untreated patients.
References
1. CSL Berhing UK Limited. Voncento Summary of Product Characteristics.
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to CSL Behring UK Ltd. on 01444 447 405.