Von Willebrand factor interacts in the following cases:
There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors. Therefore, patients at risk must be monitored for early signs of thrombosis. Prophylaxis against venous thromboembolisms should be instituted according to the current recommendations.
When using a FVIII-containing VWF preparation, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. In patients receiving factor VIII-containing von Willebrand factor products, plasma levels of FVIII:C should be monitored to avoid sustained excessive FVIII:C plasma levels, which may increase the risk of thrombotic events.
Animal studies are insufficient to assess its safety with respect to pregnancy, embryonic/fœtal development or peri- and postnatal development.
The safety of Von Willebrand factor during pregnancy ahas not been investigated in controlled clinical studies. Von Willebrand factor should be administered to pregnant von Willebrand factor deficient women only if clearly indicated.
The safety of Von Willebrand factor during lactation has not been investigated in controlled clinical studies. Von Willebrand factor should be administered to lactating von Willebrand factor deficient women only if clearly indicated.
Animal studies are insufficient to assess its safety with respect to fertility and reproduction.
No effects on the ability to drive or use machines have been observed.
Hypersensitivity or allergic reactions (which may include 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 infrequently, and may in some cases progress to severe anaphylaxis (including shock).
On rare occasions, fever has been observed.
Patients with von Willebrand disease, especially type 3 patients, may very rarely develop neutralising antibodies (inhibitors) to VWF. Patients treated with VWF should be carefully monitored for the development of inhibitors using appropriate clinical observations and laboratory tests. If such inhibitors occur, the condition will manifest itself as an inadequate clinical response. Such antibodies are precipitating and occur in close association with anaphylactic reactions. In all such cases, it is recommended that a specialised haemophilia centre be contacted.
Therefore, patients experiencing anaphylactic reaction should be evaluated for the presence of an inhibitor.
After correction of the factor Willebrand deficiency, due to the risk of a thrombotic episode in certain risk situations, monitoring for early signs of thrombosis or disseminated intravascular coagulation and prevention of thromboembolic complications should be undertaken according to current practices.
In patients receiving FVIII-containing VWF products sustained excessive FVIII:C plasma levels may increase the risk of thrombotic events.
The frequency of adverse event occurrence has been estimated according 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).
Uncommon: Hypersensitivity or allergic reactions. These may in some cases progress to severe anaphylaxis (including shock).
Uncommon: Restlessness
Uncommon: Headache, tingling, lethargy
Uncommon: Tachycardia
Uncommon: Hypotension, flushing
Uncommon: Wheezing
Uncommon: Nausea, vomiting
Uncommon: Angioedema, generalised urticaria, hives
Uncommon: Burning and stinging at the infusion site, chills, tightness of the chest
Rare: Fever
Very rare: Neutralising antibodies (inhibitors) to VWF
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