Corifact

Blood Coagulation Factors

Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.

For intravenous use only.
The units of factor XIII concentrate vary between cartons; check the vial to be used for actual factor XIII concentrate content.
Factor XIII concentrate contains no preservative; use aseptic technique during preparation and administration.
 
Reconstitution
The factor XIII vial and diluent vial must be at room temperature prior to reconstitution.
Remove flip caps of the factor XIII concentrate vial and diluent vial, swab with alcohol, and allow time to dry.
Open the Mix2Vial transfer set supplied by the manufacturer by peeling away the lid, but keep the transfer set in the clear package.
Tightly hold the diluent vial on a flat surface and push the plastic spike at the blue end of the Mix2Vial transfer set through the center of the diluent vial, and then carefully remove the clear package from the Mix2Vial (do not pull the transfer set).
Invert the diluent vial with Mix2Vial transfer set attached and push the plastic spike of the transparent adapter through the center stopper of the factor XIII concentrate vial; the diluent will automatically transfer to the factor XIII concentrate vial.
Gently swirl the vial to ensure that the product is completely dissolved. Do not shake.
After reconstitution, the solution should be colorless to slightly yellow and opalescent. Do not use if the product contains particulates.
Unscrew the diluent vial from the factor XIII concentrate vial. Withdraw appropriate volume into an empty, sterile syringe for administration.
If the same patient is to receive more than one vial, the contents of multiple vials may be pooled; however, a separate, unused Mix2Vial transfer set must be used for each vial.
Storage: After reconstitution, the product must be used within 4 hours; do not refrigerate or freeze. Discard any unused portion.
 
Intravenous injection:
Administer via a separate infusion line; do not mix with any other intravenous solution or medical product.
Administer at room temperature by slow intravenous injection at a rate not exceeding 4 mL/min.
Record the batch number in the patient's medical record.

epistaxis / Delayed / 2.0
anaphylactoid reactions / Rapid / Incidence not known
thromboembolism / Delayed / Incidence not known
thrombosis / Delayed / Incidence not known

erythema / Early / 1.0
hematoma / Early / 2.0
elevated hepatic enzymes / Delayed / 1.0
dyspnea / Early / Incidence not known
antibody formation / Delayed / Incidence not known

pruritus / Rapid / 1.0
fever / Early / 2.0
chills / Rapid / 1.0
rash / Early / 2.0
diarrhea / Early / 2.0
vomiting / Early / 2.0
abdominal pain / Early / 2.0
infection / Delayed / 2.0
headache / Early / 2.0
arthralgia / Delayed / 2.0
nausea / Early / Incidence not known

Corifact

Rx

Heat-treated, lyophilized coagulation factor XIII concentrate made from pooled human plasma
Approved for the prevention of bleeding episodes in patients with congenital factor XIII deficiency.
Serious hypersensitivity reactions may occur

40 International Units/kg IV initially. Subsequent dosing should occur every 28 days to maintain a factor XIII activity level trough of approximately 5—20%. Dosage adjustments should be guided by a specific assay used to determine the most recent factor XIII activity level trough (e.g., Berichrom activity assay) and the patient's clinical condition. An example of dosage adjustments using the Berichrom activity assay is as follows: 1 trough level of < 5%, increase dosage by 5 units/kg; trough level of 5—20%, no change in dosage; 2 trough levels of > 20% or 1 trough level of > 25%, decrease dosage by 5 units/kg.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Factor VIIa, Recombinant: (Major) The risk of potential interaction between factor VIIa, recombinant and coagulation factor concentrates has not been adequately evaluated. Simultaneous use of factor VIIa, recombinant and factor XIII concentrate should be avoided due to the potential for thrombosis.

Corifact Intravenous Inj Pwd F/Susp

Specific maximum dosage information is not available. Individualize dosage based on body weight, laboratory values, and the clinical status of the patient.

Factor XIII is an endogenous plasma glycoprotein that circulates in the blood and is found in platelets, macrophages, and monocytes. Factor XIII is a proenzyme that becomes activated in the presence of calcium to Factor XIIIa. During the coagulation cascade, Factor XIIIa promotes cross-linking of fibrin and is essential in the protection of the clot against fibrinolysis and degradation by plasmin.

Factor XIII concentrate is administered intravenously. Pharmacokinetic parameters were determined based on data from 14 patients ranging in age from 5—42 years (9 adults, 2 adolescents, and 3 children). Each patient received 40 units/kg IV every 28 days for a total of 3 doses. The doses were administered at a rate of approximately 250 units/min. After the third dose, the mean increase in Factor XIII activity levels was 83% (range 48—114%) over baseline. The mean half-life was 6.6 +/- 2.29 days and time to peak plasma concentration (Tmax) was achieved in 1.7 +/- 1.44 hours. An increase in Factor XIII plasma concentrations was seen for approximately 28 days.

It is not known whether factor XIII concentrate is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.