Coagulation factor VIII interacts in the following cases:
In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available. Therefore, factor VIII should be used during pregnancy only if clearly indicated.
Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during breast-feeding is not available. Therefore, factor VIII should be used during lactation only if clearly indicated.
Animal reproduction studies have not been conducted with factor VIII.
Coagulation factor VIII has no or negligible influence on the ability to drive and use machines.
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 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 coagulation factor VIII. If such inhibitors occur, the condition may manifest itself as an insufficient clinical response. In such cases, it is recommended that a specialised haemophilia centre be contacted.
The list presented below is according to the MedDRA system organ classification (SOC 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).
From clinical trials, non interventional studies, spontaneous reporting and regular literature screening the following adverse reactions were reported on coagulation factor VIII:
| MedDRA Standard System Organ Class | Adverse reactions | Frequency |
|---|---|---|
| Blood and lymphatic system disorders | Factor VIII inhibition | uncommon (PTPs*) very common (PUPs*) |
| Immune system disorders | Anaphylactic shock, hypersensitivity | not known |
| Skin and subcutaneous tissue disorder | Erythema, pruritus, urticaria | not known |
* Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.
With exception of factor VIII inhibition, adverse reactions in children are expected to be the same as in adults (see list above).
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