Drug Detail:Coagadex (Coagulation factor x [ koe-ag-ue-lay-tion-fak-tor-x- ])
Generic Name: Coagulation Factor X Human 100[iU] in 1mL;
Dosage Form: kit
Drug Class: Miscellaneous coagulation modifiers
For intravenous use after reconstitution only
Dose
- Dose and duration of the treatment depend on the severity of the Factor X deficiency, location and extent of the bleeding, the patient's age (<12 years or >12 years) and the patient's clinical condition.
- Base the dose and frequency on the individual clinical response. Do not administer more than 60 IU/kg daily.
- Each vial of COAGADEX is labeled with the actual Factor X potency/content in International Units (IU).
| Age | Initial dose | Further management |
|---|---|---|
| Children: Less than 12 years of age | 40 IU/kg twice weekly | Due to inter-and intra-patient variability, it is recommended that trough blood levels of Factor X should be monitored at intervals, especially in the first weeks of therapy or after dosages changes. Adjust dosage regimen to clinical response and trough levels of Factor X of at least 5 IU/dL. Do not exceed a peak level of 120 IU/dL. [For more detailed calculations of dose, see Detailed Dose Calculation (2.1)]. |
| Adults and adolescents: 12 years of age or older | 25 IU/kg twice weekly |
| Age | Initial dose | Further management |
|---|---|---|
| Children: Less than 12 years of age | 30 IU/kg | Infuse COAGADEX when the first sign of bleeding occurs [see Clinical Trial Experience (6.1)]. Repeat at intervals of 24 hours until the bleed stops. [For more detailed calculations of dose, see Detailed Dose Calculation (2.1)]. |
| Adults and adolescents: 12 years of age or older | 25 IU/kg |
| Age | Initial dose | Further management |
|---|---|---|
| Children: Less than 12 years of age | Use a factor of 0.6 to calculate the required dose | Measure post-infusion plasma Factor X levels for each patient before and after surgery to ensure that hemostatic levels are obtained and maintained. Pre-surgery: calculate the dose of COAGADEX to raise plasma Factor X levels to 70-90 IU/dL Post-surgery: Repeat 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 |
| Dose (IU) = body weight (kg) × desired factor X rise† (IU/dL or % of normal) × 0.6 | ||
| Adults and adolescents: 12 years of age or older | Use a factor of 0.5 to calculate the required dose | |
| Dose (IU) = body weight (kg) × desired factor X rise‡ (IU/dL or % of normal) × 0.5 | ||
Detailed Dose Calculation
- For young children (less than 12 years of age), the incremental recovery is approximately 1.7 IU/dL per IU/kg so the number at the end of each of the above formulae changes as follows:
Dose (IU) = Body Weight (kg) × Desired Factor X Rise (IU/dL) × 0.6
†The desired Factor X rise is the difference between the patient's plasma Factor X level and the maximum desired level.
To estimate the expected in vivo maximum increase in plasma Factor X, expressed as IU/dL (or % of normal), use the following formula:
Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)] × 1.7 - For adolescents and adults (at least 12 years of age), the incremental recovery is approximately 2.0 IU/dL per IU/kg so the number at the end of each of the above formulae changes as follows:
Dose (IU) = Body Weight (kg) × Desired Factor X Rise (IU/dL or % of normal) × 0.5
‡The desired Factor X rise is the difference between the patient's plasma Factor X level and the maximum desired level.
To estimate the expected in vivo maximum increase in plasma Factor X expressed as IU/dL (or % of normal) use the following formula:
Estimated Increment of Factor X (IU/dL or % of normal) = [Total Dose (IU)/Body Weight (kg)]× 2
Preparation and Reconstitution
- Always work on a clean surface and wash your hands before performing the following procedures.
- To reconstitute, use the diluent (Sterile Water for Injection) and transfer device (Mix2Vial) provided in the COAGADEX carton.
- To administer, you will also need a syringe and suitable needle (not provided in the COAGADEX carton).
- Bring the vials of COAGADEX and the Sterile Water for Injection to room temperature before mixing.
- The reconstitution is performed as follows:
|
|
Step 1
|
|
|
Step 3
|
|
|
Step 4
|
|
|
Step 5
|
|
|
Step 6
|
|
|
Step 8
|
Administration
For intravenous administration only
- If the dose requires more than one vial of COAGADEX:
- Reconstitute each vial (steps 1 to 5) using a new Mix2Vial for each vial
- Draw up all of the solution into a single syringe (steps 6 to 8)
- Visually inspect the final solution for particulate matter and discoloration prior to administration. Do not use if particulate matter or discoloration is observed
- Attach a suitable needle to the syringe
- Administer by intravenous infusion at a rate of 10 mL/min, but no more than 20 mL/min
