factor XIII concentrate, human concentrate
factor XIII concentrate, human (FXIII) concentrate (Human)(fak-tor thir-teen) ,
Pregnancy Category: C
Pharmacologic: blood products
ClassificationTherapeutic: none assigned
Pharmacologic: blood products
Routine preventive treatment of congenital Factor XIII deficiency.Perioperative management of surgical bleeding in patients with congenital Factor XIII deficiency
Factor XIII is a calcium- and thrombin-activated proenzyme. Once activated it catalyzes cross-linking of fibrin resulting in stabilization and resistance to fibrinolysis. Also prevents degradation of fibrin clot by plasmin; result is clot stabilization.
Replaces deficient Factor XIII thereby preventing or managing bleeding in congenital deficiency.
Absorption: IV administration results in complete bioavailability.
Metabolism and Excretion: Unknown.
Half-life: 6 days.
Time/action profile (hemostatic effect)
|IV||rapid||end of infusion||28 days|
Contraindicated in: Known severe hypersensitivity reactions to human plasma-derived products or any other components in the product.
Use Cautiously in: Obstetric: Use during pregnancy only if clearly needed; pregnancy is associated ↑ risk of thrombosis; Lactation: Use only if clearly needed.
Adverse Reactions/Side Effects
Central nervous system
Ear, Eye, Nose, Throat
- abdominal pain
- ↑ liver enzymes
- embolism (life-threatening)
- thrombosis (life-threatening)
- joint/limb injury
- allergic reactions including anaphylaxis
- antibody formation
- flu-like syndrome
Drug-Drug interactionNone noted.
Intravenous (Adults and Children) 40 units/kg; subsequent doses should be adjusted to maintain a trough FXIII level of 5–20% (should be given every 28 days for routine prophylaxis) (need for additional doses to manage perioperative bleeding based on patients FXIII level, type of surgery, and clinical response).
Concentrate for IV infusion (requires reconstitution and further dilution): 1000–1600 units/vial
- Monitor for hypersensitivity reactions (allergy, rash, pruritus, erythema, urticaria, chest tightness, wheezing, hypotension). If signs occur, discontinue infusion and institute appropriate treatment. Pyrogenic reactions (fever, chills) may also occur.
- Monitor for development of inhibitory antibodies. May manifest as inadequate response to treatment or breakthrough bleeding during prophylaxis. If suspected, perform an assay that measures FXIII inhibitory antibody concentrations.
- Lab Test Considerations: Monitor trough FXIII activity levels with each treatment.
Potential Nursing DiagnosesIneffective tissue perfusion (Indications)
- Dose is based on the most recent trough. If trough level is < 5%, ↑ dose by 5 units/kg, if trough level is 5–20% continue with 40 units/kg dose; if two trough levels >20% or one trough level >25% ↓ dose by 5 units/kg.
- Record the batch number of the product in the medical record every with each administration.
- Ensure vial is at room temperature. Do not use beyond expiration date. Reconstitute Mix2Vial as directed by manufacturer. Solution is colorless to slightly yellowish, slightly opalescent and free from visible particles. Do not administer solution that is discolored or contains a precipitate. Administer within 4 hr of reconstitution. Do not refrigerate or freeze reconstituted solution. Withdraw solution into syringe and attach syringe to IV administration set. If multiple vials are used, vial contents may be pooled using a separate Mix2Vial transfer set for each vial.
- Rate: Infuse at a rate not to exceed 4 mL/min.
- Y-Site Incompatibility: Administer through separate infusion line. Do not mix with other medications or solutions.
- Instruct patient to read the Patient Product Information before using and with each refill; new information may be available.
- Inform patient of signs and symptoms of hypersensitivity reactions; caution patient to notify health care professional promptly if these occur.
- Instruct patient to report bleeding to health care professional as a sign of immunogenicity.
- Advise patient to notify health care professional immediately if signs and symptoms of thrombosis (limb or abdomen swelling and/or pain, shortness of breath, loss of sensation or motor power, altered consciousness, vision, or speech) occur.
- Inform patient that because factor XIII concentrate is made from human blood, it may carry risk of transmitting infectious agents (viruses, Creutzfeldt-Jakob).
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs or aspirin without consulting health care professional.
- Advise patient to notify health care professional if planning to travel.
- Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
- Prevention of bleeding by replacement of deficient Factor XIII.