Factor XIII A-subunit, recombinant (Tretten, catridecacog)
Classes: Hemostatics; Coagulation Factors
Dosing and uses of Tretten (Factor XIII A-subunit, recombinant)
Dosing 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
Pediatric dosage forms and strengths
Dosing 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
Tretten (Factor XIII A-subunit, recombinant) adverse (side) effects
≥1%
Headache
Extremity pain
Injection site pain
Increased fibrin D dimer levels
<1%
Antibody formation
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
Pregnancy and 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.
Pharmacology of Tretten (Factor XIII A-subunit, recombinant)
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)
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
