Factor XIII A-subunit, recombinant (Rx)

Brand and Other Names:Tretten, catridecacog
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Dosing & Uses

AdultPediatric

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

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Interactions

Interaction Checker

and Factor XIII A-subunit, recombinant

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              • 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)

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                  Adverse Effects

                  ≥1%

                  Headache

                  Extremity pain

                  Injection site pain

                  Increased fibrin D dimer levels

                  <1%

                  Antibody formation

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                  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

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                  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.

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                  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)

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                  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
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                  Images

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Tretten intravenous
                  -
                  2,500 unit vial
                  Tretten intravenous
                  -
                  2,500 unit vial

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  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) 2021 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.

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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
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                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                  Tier Description
                  1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                  2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                  3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                  4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                  NC NOT COVERED – Drugs that are not covered by the plan.
                  Code Definition
                  PA Prior Authorization
                  Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                  QL Quantity Limits
                  Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                  ST Step Therapy
                  Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                  OR Other Restrictions
                  Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.