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Factor XIII A-Subunit (Recombinant)

Medically reviewed by Drugs.com. Last updated on Feb 29, 2020.

Pronunciation

(FAK ter THIR teen aye SUB yoo nit ree KOM be nant)

Index Terms

  • Catridecacog
  • Recombinant Factor XIII A-Subunit
  • rFXIII

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intravenous:

Tretten: 2000 - 3125 units (1 ea)

Brand Names: U.S.

  • Tretten

Pharmacologic Category

  • Antihemophilic Agent

Pharmacology

Factor XIII A-Subunit (recombinant) is a protransglutaminase (rFXIII [rA2] homodimer) and binds to free human FXIII B-subunit resulting in a heterotetramer [rA2B2]. rFXIII has been shown to be activated by thrombin in the presence of Ca2+. Activated rFXIII has been shown in dose-dependent manner to increase mechanical strength of fibrin clots, retard fibrinolysis, and rFXIII has been shown to enhance platelet adhesion to the site of injury. After combining with available plasma B-subunits, factor XIII A-subunit (recombinant) has been shown to have the same pharmacodynamic properties in plasma as endogenous FXIII.

Distribution

Distribution: Vss: Children <6 years: 61.2 ± 41 mL/kg; Adults: 65.9 ± 26.9 mL/kg.

Half-Life Elimination

Half-life: Children <6 years: 7.1 ± 1.9 days; Adults: ~ 5.1 ± 2.6 days.

Use: Labeled Indications

Factor XIII A-subunit deficiency: Routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency

Contraindications

Hypersensitivity to coagulation factor XIII A-subunit (recombinant) or any component of the formulation.

Dosing: Adult

Factor XIII A-subunit deficiency: IV: 35 units/kg once monthly to achieve a target trough level of factor XIII activity ≥10%; consider dose adjustment if adequate coverage is not achieved (higher doses may not increase the levels of tetrameric factor XIII).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Factor XIII A-subunit deficiency: Infants, Children, and Adolescents: IV: 35 units/kg/dose once monthly to achieve a target trough level of factor XIII activity ≥10%; consider dose adjustment if adequate coverage is not achieved (higher doses may not increase the levels of tetrameric factor XIII).

Reconstitution

Bring the vial of powder and diluent to room temperature, but not above 25°C (77°F). Reconstitute only with 3.2 mL sterile water (provided); do not inject the diluent directly on the powder to avoid foaming. Gently swirl; do not shake. After reconstitution, each vial contains 667-1042 units/mL recombinant coagulation factor XIII A-subunit. For smaller dose that requires less than the full volume in the vial, reconstituted solution may be diluted with sodium chloride 0.9% to facilitate measurement of small volumes; discard remaining product. Use immediately (or may store at room temperature not to exceed 25°C (77°F) for up to 3 hours).

Administration

IV: Administer IV at a rate not exceeding 1 to 2 mL/minute. Do not administer as a continuous infusion or with other infusion solutions.

Storage

Prior to reconstitution, store refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze; protect from light. If the reconstituted solution is not used immediately, store refrigerated or at room temperature not to exceed 25°C (77°F) for up to 3 hours; discard after 3 hours.

Drug Interactions

Factor VIIa (Recombinant): Factor XIII A-Subunit (Recombinant) may enhance the thrombogenic effect of Factor VIIa (Recombinant). Monitor therapy

Adverse Reactions

1% to 10%:

Central nervous system: Headache (≥1%)

Hematologic & oncologic: Increased fibrinolysis (increase in fibrin D dimer levels; ≥1%)

Immunologic: Antibody development (non-neutralizing; 2% to 5%)

Local: Pain at injection site (≥1%)

Neuromuscular & skeletal: Limb pain (≥1%)

Warnings/Precautions

Concerns related to adverse effects:

• Antibody formation: Inhibitory antibodies may occur. Patients with inhibitory antibodies may manifest as an inadequate response to treatment. Factor XIII inhibitory antibodies should be measured when breakthrough bleeding or factor XIII activity levels are suboptimal after apparent adequate dosing.

• Hypersensitivity reactions: May cause allergic reactions; discontinue immediately if signs or symptoms of anaphylaxis or hypersensitivity reactions (including urticaria, rash, tightness of the chest, wheezing, hypotension) occur and institute appropriate management.

• Thrombotic events: Thromboembolic complications may occur; monitor patients with known risk factors for thrombosis.

Other Warnings/Precautions:

• Appropriate use: Not indicated for use in patients with congenital factor XIII B-subunit deficiency.

Monitoring Parameters

Factor XIII trough levels; development of factor XIII inhibitory antibodies; hypersensitivity reactions; thrombotic events.

Pregnancy Considerations

Pregnant patients with factor XIII deficiency may have an increased risk of bleeding following abortion, antenatal procedures, and delivery. There is also a high rate of pregnancy loss without treatment; close surveillance is recommended. Maternal factor XIII concentrations decrease during pregnancy and dosing frequency should be increased. Additional treatment may be needed prior to delivery or procedures. Factor XIII A-Subunit (Recombinant) may be used in patients with a factor XIII A-subunit deficiency (RCOG [Pavord 2017]).

Patient Education

What is this drug used for?

• It is used to prevent bleeding in patients without Factor XIII A-subunit.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Painful extremities

• Injection site pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight

• Blood clots like numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain; shortness of breath; fast heartbeat; or coughing up blood

• Dizziness

• Passing out

• Severe headache

• Bruising

• Bleeding

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.