Dosing & Uses
Dosage 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
Dosage 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
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Contraindicated (0)
Serious - Use Alternative (1)
- Factor VIIa, recombinant
Factor VIIa, recombinant, Factor XIII A-subunit, recombinant. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Thrombosis occurred in preclinical trials when excessive FXIII doses were coadministered with FVIIa.
Monitor Closely (0)
Minor (0)
Adverse 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 & 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
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
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Tretten intravenous - | 2,500 unit vial | ![]() | |
Tretten intravenous - | 2,500 unit vial | ![]() |
Copyright © 2010 First DataBank, Inc.
Patient Handout
factor XIII A-subunit,recombinant intravenous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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