Pharmacokinetics

  • Mean half-life: 30.3 hours
  • Adjusted mean incremental recovery*: 2.08 IU/dl per IU/kg

*Based on the peak increment in the first hour post dose.

Runner

Dosing

COAGADEX is available in 250 IU or 500 IU range single-use vials that include a Mix2Vial™ for reconstitution

COAGADEX Dosing

Dose and duration of the treatment depend on the severity of the factor X deficiency, location and extent of the bleeding, and on the patient’s clinical condition.

Dose
(IU)
=
body weight
(kg)
x
desired factor X rise
(IU/dL or % of normal)
x
0.5
(IU/kg)/​(IU/dL)
  • On-demand
    • For treatment of bleeding episodes, infuse 25 IU/kg COAGADEX when the first sign of bleeding occurs
    • Repeat every 24 hours until the bleed stops
  • Perioperatively
    • Pre-surgery: Calculate the dose of COAGADEX needed to raise plasma factor X levels to 70-90 IU/dL
    • Post-surgery: Dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the patient is no longer at risk of bleeding due to surgery
    • It is recommended that post-infusion factor X levels are measured for each patient before and after surgery to ensure that hemostatic levels are obtained and maintained

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

Mix2Vial is a trademark of West Pharmaceuticals Services.
Reference: COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2015.

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:

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 complete Prescribing Information for COAGADEX.