Afstyla Adverse Reactions

Summary of the safety profile: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with the use of factor VIII products and may in some cases progress to severe anaphylaxis (including shock) (see also Precautions). Hypersensitivity reactions were observed in clinical trial of AFSTYLA (see ADR table as follows), no anaphylactic reactions were reported.
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. Development of neutralising antibodies (inhibitors) to factor VIII was observed in the clinical trial in previously untreated patients with AFSTYLA (see ADR table as follows).
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).

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Inhibitor development has been observed in PUPs in the clinical study and in post marketing use. In the clinical study, a majority of inhibitors resolved with continuous treatment with AFSTYLA.
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.