Adynovate Adverse Reactions

Summary of the safety profile: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADYNOVATE. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.
Tabulated list of adverse reactions: The safety of ADYNOVATE was evaluated in 365 previously treated patients with severe haemophilia A (factor VIII less than 1% of normal), who received at least one dose of ADYNOVATE in 6 completed multi-center, prospective, open label clinical studies and 1 ongoing clinical study.
The table presented as follows is according to the MedDRA system organ classification (System Organ Class and Preferred Term Level).
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 3.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Hypersensitivity: The observed event of hypersensitivity was a mild transient non-serious rash, occurring in one 2-year-old patient who had developed a previous rash while on ADYNOVATE.
Paediatric population: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. The safety of ADYNOVATE was evaluated in 38 subjects < 6 years and 34 subjects 6 to < 12 years of age having accumulated a total of 2880 EDs and 2975 EDs respectively. The mean (SD) age was 3.3 (1.55) and 8.1 (1.92) years respectively.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation 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 via the national reporting system.