Coagulation factor X Other names: Stuart-Prower factor Prothrombinase

Coagulation factor X is likely to be counteracted by factor Xa inhibitors, direct or indirect. These antithrombotic agents should not be used in patients with factor X deficiency. Coagadex should not be used as an antidote to the effects of direct oral anti-coagulants (DOACs) in patients who do not have factor X deficiency.

Allergic type hypersensitivity reactions, including anaphylaxis, are possible. Coagadex contains traces of human proteins other than factor X. Patients should be informed of the early signs of hypersensitivity reactions including angioedema, infusion site inflammation (e.g. burning, stinging, erythema), chills, cough, dizziness, fever, flushing, generalised urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing. If any of these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician. In case of shock, the current medical standards for shock treatment should be observed.

Due to the rarity of hereditary factor X deficiency, experience regarding the use of coagulation factor X during pregnancy and breast-feeding is not available. Therefore, coagulation factor X should be used during pregnancy only if clearly indicated.

Due to the rarity of hereditary factor X deficiency, experience regarding the use of coagulation factor X during pregnancy and breast-feeding is not available. Therefore, coagulation factor X should be used during breast-feeding only if clearly indicated.

Fertility

Animal reproduction studies have not been conducted with coagulation factor X.

Coagulation factor X has no or negligible influence on the ability to drive and use machines.

Summary of safety profile

The adverse reactions that occurred in the highest frequency were infusion site erythema, infusion site pain, fatigue, and back pain.

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 with treatment of other haemophilias and may in some cases have progressed to severe anaphylaxis (including shock). Hypersensitivity reactions, allergic reactions, and anaphylaxis have not been reported in coagulation factor X clinical trials.

Tabulated list of adverse reactions

The following adverse reactions have been reported in clinical studies involving 27 patients treated with coagulation factor X. Frequencies have been evaluated according to the following convention: very common (≥1/10 subjects); common (≥1/100 to <1/10). Frequencies of uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000) cannot be estimated from the available data

List of adverse reactions (ADRs) in 27 treated subjects:

Musculoskeletal and connective tissue disorders

Common: Back pain

General disorders and administration site conditions

Common: Infusion site erythema, Fatigue, Infusion site pain

Paediatric population

Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.