Coagadex Dosage

Generic name: Coagulation Factor X Human 100[iU] in 1mL;
Dosage form: kit
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Drugs.com. Last updated on Apr 19, 2023.

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).

Prophylaxis of bleeding episodes
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

On–demand treatment and control of bleeding episodes
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

Perioperative management of bleeding
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:

Table 1 COAGADEX Reconstitution Instructions
	Step 1 Remove the cap from the vial of COAGADEX and clean the top of the rubber stopper with an alcohol swab (not supplied) and allow to dry prior to opening the Mix2Vial package. Repeat this step with the vial of sterile water. Step 2 Peel back the top of the Mix2Vial package. Do not remove the device from the package.
	Step 3 Place the blue end of the Mix2Vial over the water vial and push straight down until the spike penetrates the rubber stopper and snaps into place. Remove the plastic outer packaging from the Mix2Vial and discard it. Do not touch the exposed end of the device.
	Step 4 With the COAGADEX vial placed on a flat surface, invert the water vial with the Mix2Vial device still attached. Place the clear end of the Mix2Vial on the product vial and push straight down until the spike penetrates the rubber stopper and snaps into place. The water will automatically transfer into the COAGADEX vial by the vacuum contained within it. Do not use if the water is not pulled into the vial of COAGADEX.
	Step 5 Gently swirl the COAGADEX vial to make sure that the powder is fully dissolved. Do not shake the vial. The reconstituted solution should be clear or a slightly pearl-like solution. Do not use if particulate matter or discoloration is observed and contact BPL.
	Step 6 Separate the empty water vial and blue part of the Mix2Vial from the clear part that is attached to the COAGADEX vial by unscrewing counter-clockwise. Step 7 Draw air into an empty, sterile syringe (not supplied) by pulling the plunger to the volume of water added. Connect the syringe to the clear part of the Mix2Vial and push the air in the syringe into the vial.
	Step 8 Immediately invert the COAGADEX vial. The solution will automatically be drawn into the syringe. Draw the remaining solution into the syringe by pulling the plunger back slowly. Disconnect the filled syringe from the device. Use the product immediately after reconstitution. Do not store the reconstituted product.

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