Approved Dosing for COAGADEX
- 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.