Safety profile
Demonstrated safety profile
Adverse reactions1
- 221 subjects constituted the safety population from three studies1
- The most-frequently reported (≥5%) adverse reactions in clinical trials in PTPs (N=221) were:1
- Headache (13.1%)
- Cough (8.1%)
- Pyrexia (9.0%)
Hypersensitivity reaction1
- One patient (19 years of age) experienced a hypersensitivity reaction associated with a transient increase of IgM anti-PEG antibody titre, which was negative upon retest during follow-up. The reaction occurred on the 4th ED in a patient with pre-existing asthma and was resolved using standard asthma treatment.1
FVIII inhibitors1
- No de novo or confirmed cases of inhibitor against FVIII occurred1,6
- A single unconfirmed positive result of a low titre of FVIII inhibitor (1.7 BU/mL) was reported in one adult patient undergoing surgery1
- Inhibitors to FVIII are a known complication in the management of patients with hemophilia A1
