Factor XIII A-subunit, recombinant (Rx)

≥1%

Headache

Extremity pain

Injection site pain

Increased fibrin D dimer levels

<1%

Antibody formation

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

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.

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)

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