Factor XIII A-Subunit (Recombinant)

Class: Hemostatics
VA Class: BL500
Chemical Name: Human Factor XIII [A2] homodimer (allele F13A*1B), recombinant DNA origin
Molecular Formula: C₃₇₀₈H₅₇₃₅N₁₀₁₃O₁₁₁₁S₂₈
CAS Number: 606138-08-3
Brands: Tretten

Medically reviewed by Drugs.com on Feb 17, 2022. Written by ASHP.

Introduction

Biosynthetic (recombinant DNA origin) preparation of human factor XIII A₂ homodimer consisting of 2 factor XIII A-subunits.

Uses for Factor XIII A-Subunit (Recombinant)

Congenital Factor XIII A-subunit Deficiency

Routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency; designated an orphan drug by FDA for such use.

Prophylactic therapy with factor XIII concentrate is recommended in all patients with severe (<1% factor XIII activity) deficiency; considered current standard of care.

Factor XIII concentrate currently available in the US as a plasma-derived (Corifact) and a recombinant (Tretten) preparation. Some experts recommend preferential use of recombinant preparations because of potentially superior safety profile with respect to pathogen transmission. When selecting an appropriate factor XIII preparation, consider characteristics of each clotting factor concentrate in addition to individual patient variables.

Not effective and should not be used in patients with factor XIII B-subunit deficiency.

Factor XIII A-Subunit (Recombinant) Dosage and Administration

Administration

IV Administration

Administer by slow IV injection. (See Rate of Administration under Dosage and Administration.) Do not administer by continuous IV infusion.

Initiate therapy under supervision of a clinician experienced in the treatment of rare bleeding disorders. May be self-administered in the home setting after appropriate training provided.

Do not administer in the same IV line with other infusion solutions.

Reconstitution

Reconstitute lyophilized drug with sterile water for injection provided by manufacturer. Prior to reconstitution, allow drug vial and diluent to warm to (but not exceed) room temperature (25°C). To avoid foaming, do not inject diluent directly onto powder. Gently swirl vial; do not shake. Resulting solution should be clear and colorless; discard if particulate matter or discoloration observed.

May dilute solution with 0.9% sodium chloride injection to facilitate measurement of small doses (volumes) for administration.

Administer immediately after reconstitution or within 3 hours. If not used immediately, store in refrigerator or at room temperature (not to exceed 25°C). Discard unused portion.

Consult manufacturer's information for additional details on reconstitution and preparation of the drug.

Rate of Administration

Administer at a rate not exceeding 1–2 mL/minute.

Dosage

Dosage expressed in international units (IU, units). Each vial contains 2000–3125 units of factor XIII A-subunit (recombinant); actual number of units indicated on each vial and carton.

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