Factor XIII Concentrate (Human)
Pronunciation: FAK-tor thirteen
Class: Antihemophilic agents
- Injection, lyophilized powder for solution 1,000 to 1,600 units
Restores hemostasis in patients with factor XIII deficiency.
C max and AUC at steady state are approximately 0.9 units/mL and 184 units•h/mL, respectively. T max is approximately 1.7 h.
Vd at steady state is 51.1 mL/kg.
Half-life is 6.6 days and Cl is approximately 0.25 mL/h/kg.
Approximately 28 days.
Indications and Usage
For routine prophylactic treatment of congenital factor XIII deficiency.
History of anaphylactic or severe systemic reactions to human plasma–derived products or to any components in factor XIII.
Dosage and AdministrationAdults and Children
IV 40 units/kg initially by slow IV injection at a rate not to exceed 4 mL/min. Dosage adjustments should be based on trough factor XIII activity levels (target level of 5% to 20% using Berichrom activity assay) and the patient's clinical response; repeat every 4 wk. If there is 1 trough level of less than 5%, increase dosage by 5 units/kg; if trough level of 5% to 20%, no dosage change; if 2 trough levels of more than 20%, decrease dosage by 5 units/kg; if 1 trough level of more than 25%, decrease dosage by 5 units/kg.
- Administer by IV infusion at a rate not to exceed 4 mL/min.
- Reconstitute with provided sterile water for injection.
- The reconstituted solution should be brought to room temperature prior to infusing.
- Administer through a separate infusion line.
- Do not mix factor XIII with any other medicinal products.
- For single-use only and contains no preservatives. Discard partially used vials.
- The solution should be used within 4 h after reconstitution.
Store between 36° and 46°F; do not freeze. Protect from light. May be stored at room temperature (77°F or less) for up to 6 mo. Do not return the product to the refrigerator after it is stored at room temperature. Do not refrigerate or freeze the reconstituted solution.
Do not mix factor XIII concentrate (human) with other drugs; administer through a separate infusion line.
Embolism, thrombosis (postmarketing).
Headache, head injury (more than 2%).
Rash (more than 2%).
Abdominal pain, diarrhea, vomiting (more than 2%).
Hypersensitivity reactions including allergy, rash, pruritus, and erythema (more than 1%); allergic/anaphylactic reaction (including cutaneous reactions, alteration in BP, nausea, dyspnea, fever, and chills) (postmarketing).
Elevated thrombin-antithrombin levels, increase in hepatic enzymes (more than 1%).
Arthralgia, joint injury, limb injury (more than 2%).
Upper respiratory tract infection (more than 2%).
Contusion, epistaxis, fever, flu-like syndrome, hematoma (more than 2%); chills/rise in temperature (more than 1%); factor XIII inhibitor formation, pyrexia, transmission of an infectious agent (postmarketing).
Monitoring of patients' trough factor XIII activity level is recommended during treatment with factor XIII. If breakthrough bleeding occurs or if expected peak plasma factor XIII activity levels are not attained, an investigation to determine the presence of factor XIII inhibitory antibodies should be performed.
Category C .
There were no apparent differences in the safety profile in children compared with adults.
Hypersensitivity reactions (including allergy, rash, pruritus, and erythema) have occurred.
Development of inhibitory antibodies against factor XIII has been detected in patients and may manifest as an inadequate response to treatment.
Thromboembolic events have been reported; pregnant women may be at increased risk because of hypercoagulable state.
Transmission of viral infections
Product is prepared from pooled units of human plasma and may carry a risk of transmitting infectious agents (eg, Creutzfeldt-Jakob disease).
No symptoms have been reported.
- Advise patient or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
- Inform patients of signs and symptoms of allergic hypersensitivity reactions (eg, urticaria, rash, tightness of chest, wheezing, hypotension and/or anaphylaxis) that may occur during or after an injection of the drug. Instruct patient to contact their health care provider and/or seek immediate emergency care depending on the severity of the reaction.
- Inform patients of the signs and symptoms of immunogenicity such as breakthrough bleeding.
- Instruct patients about the risk of thromboembolic events and to look for symptoms of thrombosis, including limb or abdomen swelling and/or pain; chest pain; shortness of breath; loss of sensation or motor power; and altered consciousness, vision, or speech.
- Inform patients that the drug is made from human blood and may carry a risk of transmitting infectious agents, such as viruses, and, theoretically, Creutzfeldt-Jakob disease.
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