COAGADEX Powder and solvent for solution for injection Ref.[9429] Active ingredients: Coagulation factor X

Hypersensitivity

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.

Inhibitors

The formation of neutralising antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency.

In general, all patients treated with Coagadex should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. If expected factor X activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor X inhibitor concentration.

Transmissible Agents

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.

Vaccination against hepatitis A and B in patients who regularly or repeatedly receive human plasma-derived Factor X products may be warranted.

It is strongly recommended that every time that Coagadex is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

Sodium Content

Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium. To be taken into consideration for patients on a controlled sodium diet.

Coagadex 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

Pregnancy

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

Breast-feeding

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

Fertility

Animal reproduction studies have not been conducted with Coagadex.

Coagadex 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 Coagadex clinical trials.

Tabulated list of adverse reactions

The following adverse reactions have been reported in clinical studies involving 27 patients treated with Coagadex. 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 (see section 5.1).

For safety information with respect to transmissible agents, see section 4.4.

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 listed in Appendix V.

In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.

The product should only be reconstituted using the Mix2Vial that is provided in the pack.