Factor XIII A-subunit deficiency: 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).
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).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Factor XIII A-subunit, recombinant human: Drug information")
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).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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%)
Hypersensitivity to coagulation factor XIII A-subunit (recombinant) or any component of the formulation.
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.
Potency is shown as a range for each vial (2,000 to 3,125 units/vial). The actual units of potency of recombinant coagulation factor XIII A-subunit are stated on each vial label and carton.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Tretten: 2000 - 3125 units (1 ea)
No
Solution (reconstituted) (Tretten Intravenous)
2500 unit (Price provided is per AHF Unit): $21.66
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Tretten: 2000 - 3125 units (1 ea)
IV: Administer IV only at a rate not exceeding 1 to 2 mL/minute. Do not administer with other infusion solutions. Do not administer as drip.
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.
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.
Routine prophylaxis of bleeding in patients with congenital factor XIII A-subunit deficiency (FDA approved in all ages).
Note: Not indicated for use in patients with congenital factor XIII B-subunit deficiency.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Factor VIIa (Recombinant): Factor XIII A-Subunit (Recombinant) may enhance the thrombogenic effect of Factor VIIa (Recombinant). Risk C: Monitor therapy
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]).
Factor XIII trough levels in conjunction with clinical response to assess efficacy; factor XIII inhibitory antibodies if inadequate clinical response and/or factor XIII trough levels are suboptimal; signs/symptoms of hypersensitivity reactions, and thrombotic events.
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.
Half-life: Children <6 years: 7.1 ± 1.9 days; Adults: ~ 5.1 ± 2.6 days.
Distribution: Vss: Children <6 years: 61.2 ± 41 mL/kg; Adults: 65.9 ± 26.9 mL/kg.
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