Infant Data
Results
FDA APPROVED INDICATION
Coagulation factor XIII is indicated for prophylaxis and perioperative management of surgical bleeding in pediatric patients with congenital factor XIII deficiency.
CONTRAINDICATIONS
Contraindicated in patients with anaphylactic or severe systemic reaction to human plasma-derived products or to any other component of the product.
PRECAUTIONS
- This product is a human plasma derivative and there is an increased risk of transmission of infectious agents, including viruses and theoretical risk of Creutzfeldt-Jakob disease agent.
- Hypersensitivity reactions have been reported. If anaphylaxis or hypersensitivity reaction occur, immediately discontinue and institute appropriate treatment.
- Development of inhibitory antibodies have been detected.
- Thromboembolic complications have been reported
ADVERSE EFFECTS
The most common adverse reactions are joint inflammation, hypersensitivity, arthralgia, rash, pruritus, erythema, hematoma, headache, elevated thrombin-antithrombin levels, and increased blood lactate dehydrogenase.
ADMINISTRATION
Do not exceed 4 mL/min during administration. The final concentration of factor XIII solution is 50 to 80 international units/mL.
MONITORING
Monitor trough Factor XIII activity levels during treatment, and during and after surgery, to maintain an activity level of 5% to 20%. Monitor for development of inhibitory antibodies. If an adequate response is not seen with appropriate doses or bleeding is not controlled, perform an assay that measures factor XIII inhibitory antibody concentrations. Monitor for thromboembolic complications in patients with known risk factors.