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The following standard categories of frequency are used where data are available: 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 (frequency cannot be estimated from the available data). (See Table 6.)
Click on icon to see table/diagram/imageDescription of selected adverse reactions: FVIII inhibition: Patients with haemophilia A may develop neutralising antibodies (inhibitors) to FVIII. If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
VWF inhibition: Patients with VWD, especially type 3 patients, may develop neutralising antibodies (inhibitors) to VWF. If such inhibitors occur, the condition will manifest itself as an inadequate clinical response. Such antibodies are precipitating and may occur concomitantly to anaphylactic reactions. Therefore, patients experiencing an anaphylactic reaction should be evaluated for the presence of an inhibitor.
Hypersensitivity (allergic reactions): Includes: angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing have been observed on occasion, and may in some cases progress to severe anaphylaxis (including shock).
Thromboembolic events: In patients with VWD, there is a risk of occurrence of thromboembolic events, particularly in patients with known clinical or laboratory risk factors. In patients receiving FVIII-containing VWF products, sustained excessive FVIII:C plasma levels may increase the risk of thromboembolic events.
For safety with respect to transmissible agents, see Precautions.
Paediatric population: Frequency, type and severity of adverse reactions in the Haemophilia A paediatric population is expected to be the same as in that observed in the adult population.
Frequency, type and severity of adverse reactions in the von Willebrand paediatric population is expected to be the same as in that observed in the adult population.
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.
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