Select an Indication for COAGADEX:

Calendar icon Routine
(prophylaxis)
years
For children under 12 years of age, the initial dose of COAGADEX for prophylaxis is 40 IU/kg twice weekly.
For a child weighing , the initial dose is:
IU twice weekly
For adults and adolescents 12 years of age and older, the initial dose of COAGADEX for prophylaxis is 25 IU/kg twice weekly.
For an adult or adolescent weighing , the initial dose is:
IU twice weekly
Blood droplet and hand icon As Needed
(on-demand)
years
For children under 12 years of age, the initial dose of COAGADEX for as needed (on-demand) treatment of bleeding episodes is 30 IU/kg. Infuse COAGADEX when the first sign of bleeding occurs.
For a child weighing , the initial dose is:
IU
For adults and adolescents 12 years of age and older, the initial dose of COAGADEX for as needed (on-demand) treatment of bleeding episodes is 25 IU/kg. Infuse COAGADEX when the first sign of bleeding occurs.
For an adult or adolescent weighing , the initial dose is:
IU
Doctor icon Perioperative
Management
years
IU/dL
(% of normal)
IU/dL
(% of normal)

Desired factor X level

Pre-surgery: Raise plasma factor X levels to 70-90 IU/dL

Post-surgery: Maintain plasma factor X levels at ≥50 IU/dL until the patient is no longer at risk of bleeding due to surgery

For a child weighing , with a current factor X level of IU/dL and a desired factor X level of IU/dL (% of normal), the pre-surgery dose is:
IU
For an adult or adolescent weighing , with a current factor X level of IU/dL, and a desired factor X level of IU/dL (% of normal), the pre-surgery dose is:
IU

Indications and Usage for COAGADEX

COAGADEX, a plasma-derived blood coagulation factor X concentrate, is indicated in adults and children with hereditary factor X deficiency for:

  • Routine prophylaxis to reduce the frequency of bleeding episodes
  • On-demand treatment and control of bleeding episodes
  • Perioperative management of bleeding in patients with mild and moderate hereditary factor X deficiency

Limitation of Use

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

Contraindication for COAGADEX

COAGADEX is contraindicated in patients who have had life-threatening hypersensitivity reactions to COAGADEX.

Important Safety Information for COAGADEX

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

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 complete Prescribing Information for COAGADEX.