Factor XIII A-subunit, recombinant (Rx)

Brand and Other Names:Tretten, catridecacog
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Dosing & Uses

AdultPediatric

Dosage Forms & Strength

lyophilized powder for reconstitution

  • Actual amount of international units (IU) stated on each carton and vial
  • 2000-3125 IU/vial (667-1042 IU/mL following reconstitution)

Factor XIII Deficiency

Indicated for routine prevention of bleeding in patients with congenital Factor XIII A-subunit deficiency

35 IU/kg IV once monthly to achieve target trough level of FXIII activity ≥10% using a validated assay

May adjust dose if recommended dose (ie, 35 IU/kg/month) does not achieve adequate results

Dosage Forms & Strength

lyophilized powder for reconstitution

  • Actual amount of international units (IU) stated on each carton and vial
  • 2000-3125 IU/vial (667-1042 IU/mL following reconstitution)

Factor XIII Deficiency

Indicated for routine prevention of bleeding in patients with congenital Factor XIII A-subunit deficiency

35 IU/kg IV once monthly to achieve target trough level of FXIII activity ≥10% using a validated assay

May adjust dose if recommended dose (ie, 35 IU/kg/month) does not achieve adequate results

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Interactions

Interaction Checker

and Factor XIII A-subunit, recombinant

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            Adverse Effects

            ≥1%

            Headache

            Extremity pain

            Injection site pain

            Increased fibrin D dimer levels

            <1%

            Antibody formation

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            Warnings

            Contraindications

            Hypersensitivity

            Caution

            Allergic reactions reported, including urticaria, rash, chest tightness, wheezing, and hypotension; if these symptoms occur, discontinue immediately and institute appropriate treatment

            Thromboembolic complications reported; monitor patients with predisposing conditions for thrombosis

            Coadministration with Factor VIIa may cause thrombosis

            Inhibitory antibodies may occur and result in inadequate response to treatment; if expected plasma FXIII activity levels are not attained, or if breakthrough bleeding occurs while receiving prophylaxis, perform an assay that measures FXIII inhibitory antibody concentrations

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: Unknown if distributed in human breast milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant human factor XIII-A2 homodimer composed of 2 FXIII A-subunits

            FXIII is the terminal enzyme in the blood coagulation cascade; when activated by thrombin at the site of vessel wall injury, FXIII plays an important role in the maintenance of hemostasis through cross-linking of fibrin and other proteins in the fibrin clot

            Absorption

            Peak plasma concentration: 0.71 IU/mL (adults); 0.48 IU/mL (children)

            AUC: 128.3 IU•hr/mL (adults); 107.8 IU•hr/mL (children)

            Distribution

            Vd: 65.9 mL/kg (adults); 61.2 mL/kg (children)

            Elimination

            Half-life: 5.1 days (adults); 7.1 days (children)

            Clearance: 0.33 mL/hr/kg (adults); 0.41 mL/hr/kg (children)

            Mean residence time (MRT): 7.9 (adults); 7.5 (children)

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            Administration

            IV Preparation

            The product can be reconstituted using the vial adapter included or a needle and syringe

            Use aseptic technique

            Bring lyophilized powder and sterile water for injection (diluent) to room temperature, but not above 25°C (77°F)

            Reconstitute only with 3.2 mL sterile water for injection (provided)

            Hold the syringe slightly tilted with vial facing downward; push the plunger slowly to inject all water (3.2 mL) into the powder vial

            Do not inject the diluent directly on the powder to avoid foaming

            Gently swirl the vial until all material is dissolved

            DO NOT SHAKE the vial

            Reconstituted product is a clear and colorless solution

            Use reconstituted solution immediately; if not, store the solution refrigerated or at room temperature not to exceed 25°C (77°F) for up to 3 hr

            IV Administration

            Inspect reconstituted solution visually for particulate matter and discoloration prior to administration; do not use if particulate matter or discoloration is observed

            Administer IV at a rate not exceeding 1-2 mL/minute

            Do not administer with other infusion solutions

            Do not administer as drip

            Storage

            Unopened vials (before reconstitution)

            • Store refrigerated between 2-8°C [36-46°F]) in original carton and protect from light
            • Do not freeze

            Reconstituted vials

            • Use within 3 hr following reconstitution
            • Store solution refrigerated or at room temperature not to exceed 25°C (77°F) for up to 3 hr
            • Discard after 3 hr
            • Discard partially used vials
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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