Patients with hemophilia A may develop neutralizing antibodies (inhibitors) to factor VIII, including AFSTYLA. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialized hemophilia center be contacted. No such reactions have been observed in completed clinical trials in previously treated patients with AFSTYLA.
Tabulated list of adverse reactions: The table presented as follows is according to the MedDRA system organ classification (SOC and Preferred Term level).
Frequencies have been evaluated on a per patient basis based on data from completed clinical trials according to the following convention: very common: ≥ 1/10; common ≥ 1/100 and <1/10; uncommon: ≥ 1/1,000 and <1/100; rare: ≥ 1/10,000 and <1/1,000; very rare < 1/10,000; not known (cannot be estimated from the available data). (See Table 4).
Click on icon to see table/diagram/image
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
View ADR Monitoring Form