Approved Dosing for COAGADEX

Golfer

  • Each vial of COAGADEX contains the labeled amount of factor X in international units (IU)
  • The dosage and duration of treatment depend on the severity of the factor X deficiency, on the location and extent of the bleeding and on the patient’s clinical condition
  • For adolescents and adults (at least 12 years of age), the dose to achieve a desired in vivo peak increase in factor X level may be calculated using the following formula:
    Dose
    (IU)
    = body weight
    (kg)
    x desired factor X rise
    (IU/dL or % of normal)
    x 0.5
    (IU/kg)/(IU/dL)
  • For young children (less than 12 years of age), the dose to achieve a desired in vivo peak increase in factor X level may be calculated using the following formula:
    Dose
    (IU)
    = body weight
    (kg)
    x desired factor X rise
    (IU/dL or % of normal)
    x 0.6
    (IU/kg)/(IU/dL)

Dosing Instructions for COAGADEX

For prophylaxis of bleeding episodes

Age Initial Dose Further Management
<12 years 40 IU/kg twice weekly Monitor trough blood levels of factor X targeting ≥5 IU/dL and adjust dosage to clinical response and trough levels. Do not exceed a peak level of 120 IU/dL
≥12 years 25 IU/kg twice weekly

For treatment of bleeding episodes

Age Initial Dose Further Management
<12 years 30 IU/kg Repeat at intervals of 24 hours until the bleed stops
≥12 years 25 IU/kg

For perioperative management

To calculate initial dose, please refer to the above formulas highlighted in blue
Age Initial Dose Further Management
<12 years Use a factor of 0.6 to calculate the required dose
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
≥12 years Use a factor of 0.5 to calculate the required dose

Reference: COAGADEX® (Coagulation Factor X, Human) Prescribing Information. Durham, NC: BPL Limited. 2018.

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:

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 with known hypersensitivity to any of the components of the product.

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.