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Corifact Dosage

Generic name: Factor XIII Concentrate (Human) 1600[iU] in 20mL;
Dosage form: injection

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Dosage

Corifact dosing regimen should be individualized based on body weight, laboratory values, and the patient's clinical condition.

Dosing Schedule

Initial dose

  • 40 International Units (units) per kg body weight
  • The injection rate should not exceed 4 mL per minute.

Subsequent dosing

  • Dosing should be guided by the most recent trough FXIII activity level, with dosing every 28 days (4 weeks) to maintain a trough FXIII activity level of approximately 5% to 20%.1 Recommended dosing adjustments of ±5 units per kg should be based on trough FXIII activity levels as shown in Table 1 and the patient's clinical condition (see Pharmacokinetics [12.3]).
  • Dosing adjustments should be guided based on a specific assay used to determine FXIII levels. An example of dose adjustment using the Berichrom activity assay is outlined in Table 1 below.
Table 1: Dose Adjustment Using the Berichrom Activity Assay
Factor XIII Activity Trough Level (%) Dosage Change
One trough level of <5% Increase by 5 units per kg
Trough level of 5% to 20% No change
Two trough levels of >20% Decrease by 5 units per kg
One trough level of >25% Decrease by 5 units per kg

The potency expressed in units is determined using the Berichrom activity assay, referenced to the current International Standard for Blood Coagulation Factor XIII, Plasma. Therefore, a unit herein is equivalent to an International Unit.

Preparation and Reconstitution

  • For intravenous use only.
  • Reconstitute, using aseptic techniques, prior to use.
  • Do not use Corifact beyond the expiration date on the vial label and carton.
  • Perform a visual inspection of the reconstituted solution. It should be colorless to slightly yellowish, slightly opalescent, and free from visible particles.
  • Administer Corifact using aseptic techniques to maintain product sterility.
  • Corifact is for single use only. Contains no preservatives. The product must be used within 4 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution. Discard partially used vials.

The procedures below are provided as general guidelines for the preparation and reconstitution of Corifact.

Reconstitute Corifact at room temperature as follows:

1.
Ensure that the Corifact vial and diluent vial are at room temperature. Prepare and administer using aseptic techniques.
2.
Place the Corifact vial, diluent vial, and Mix2Vial™ transfer set on a flat surface.
3.
Remove Corifact and diluent vial flip caps and treat the stoppers with the alcohol swab provided, and allow to dry prior to opening the Mix2Vial transfer set package.
4.
Open the Mix2Vial transfer set package by peeling away the lid (Fig. 1). Leave the Mix2Vial transfer set in the clear package.
Figure 1
Fig. 1
5.
Place the diluent vial on a flat surface and hold the vial tightly. Grip the Mix2Vial transfer set together with the clear package and push the plastic spike at the blue end of the Mix2Vial transfer set firmly through the center of the stopper of the diluent vial (Fig. 2).
Figure 2
Fig. 2
6.
Carefully remove the clear package from the Mix2Vial transfer set. Make sure that you pull up only the clear package, not the Mix2Vial transfer set (Fig. 3).
Figure 3
Fig. 3
7.
With the Corifact vial placed firmly on a flat surface, invert the diluent vial with the Mix2Vial transfer set attached and push the plastic spike of the transparent adapter firmly through the center of the stopper of the Corifact vial (Fig. 4). The diluent will automatically transfer into the Corifact vial.
Figure 4
Fig. 4
8.
With the diluent and Corifact vial still attached to the Mix2Vial transfer set, gently swirl the Corifact vial to ensure that the Corifact is fully dissolved (Fig. 5). Do not shake the vial.
Figure 5
Fig. 5
9.
With one hand, grasp the Corifact side of the Mix2Vial transfer set and with the other hand grasp the blue diluent-side of the Mix2Vial transfer set, and unscrew the set into two pieces. (Fig. 6).
Figure 6
Fig. 6
10.
Draw air into an empty, sterile syringe. While the Corifact vial is upright, screw the syringe to the Mix2Vial transfer set. Inject air into the Corifact vial. While keeping the syringe plunger pressed, invert the system upside down and draw the concentrate into the syringe by pulling the plunger back slowly. (Fig. 7).
Figure 7
Fig. 7
11.
Now that the concentrate has been transferred into the syringe, firmly grasp the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe from the Mix2Vial transfer set (Fig. 8). Attach the syringe to a suitable intravenous (IV) administration set.
Figure 8
Fig. 8
12.
After reconstitution, administration should begin promptly or within 4 hours.
13.
If the same patient is to receive more than one vial, you may pool the contents of multiple vials. Use a separate unused Mix2Vial transfer set for each product vial.
14.
Corifact is for single use only. Contains no preservatives. The product must be used within 4 hours after reconstitution. Do not refrigerate or freeze the reconstituted solution. Discard partially used vials.

Administration

  • Do not mix Corifact with other medicinal products, and administer Corifact through a separate infusion line.
  • Use aseptic techniques when administering Corifact.
  • Administer Corifact after it has been brought to room temperature. It should be administered by slow intravenous injection at a rate not exceeding 4 mL per minute.
  • Record the batch number of the product in the patient's medical records every time Corifact is administered to the patient.
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