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COAGADEX is the first and only treatment specifically for hereditary factor X deficiency

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Coagadex vial

COAGADEX is a high-purity product that contains more than 94% factor X

Until recently, the treatments available were designed for other diseases and contain larger amounts of other proteins, such as factors II and IX, in addition to factor X.

Taking these extra proteins when you don’t need them can cause blood clots that may block blood vessels and cause serious injury (for example: stroke or blood clots in the lung or leg).

Learn more about COAGADEX

Until recently, the treatments available were designed for other diseases and contain larger amounts of other proteins, such as factors II and IX, in addition to factor X.

Taking these extra proteins when you don’t need them can cause blood clots that may block blood vessels and cause serious injury (for example: stroke or blood clots in the lung or leg).

Learn more about COAGADEX

Factor X deficiency is a rare bleeding disorder

It is caused by having too little of a protein called factor X in the blood.

Factor X plays an important role in blood clotting (coagulation). People with factor X deficiency have a higher risk of excess bleeding.

Factor X illustration

Need help and support for factor X deficiency?

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Indications for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children (aged 12 years and above) with hereditary factor X deficiency for:

  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding in patients with mild hereditary factor X deficiency

Limitation of Use

Perioperative management of bleeding in major surgery in patients with moderate and severe hereditary factor X deficiency has not been studied.

Important Safety Information for COAGADEX

COAGADEX is contraindicated in patients with known hypersensitivity to any of the components of the product.

Allergic type hypersensitivity reactions, including anaphylaxis, are possible with COAGADEX. If symptoms occur, patients should discontinue use of the product immediately and contact their physician.

The formation of neutralizing antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. Carefully monitor patients taking COAGADEX for the development of inhibitors by appropriate clinical observations and laboratory tests.

COAGADEX is made from human plasma and may contain infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. No cases of transmission of viral diseases, vCJD or CJD, have been associated with the use of COAGADEX.

In clinical studies, the most common adverse reactions (frequency ≥5% of subjects) with COAGADEX were infusion site erythema, infusion site pain, fatigue and back pain.

Please see Full Prescribing Information for complete prescribing details.