Adult Dosing
Congenital FXIII deficiency
- Initial dose: 40 units/kg IV at a rate not exceeding 4 mL/minute
- Administer dose q4 wks to maintain a trough FXIII activity level of approximately 5-20%
- Dose adjustment based on trough FXIII activity levels:
- One FXIII trough level of <5%: Increase by 5 units/kg
- Trough level of 5-20%: No dose change
- Two FXIII trough levels of >20% or one trough level of >25%: Decrease by 5 units/kg
- Recommended for IV use only
- Product should be used within 4 hrs after reconstitution; discard partially used vials
Pediatric Dosing
Congenital FXIII deficiency
- Initial dose: 40 units/kg IV at a rate not exceeding 4 mL/minute
- Administer dose q4 wks to maintain a trough FXIII activity level of approximately 5-20%
- Dose adjustment based on trough FXIII activity levels:
- One FXIII trough level of <5%: Increase by 5 units/kg
- Trough level of 5-20%: No dose change
- Two FXIII trough levels of >20% or one trough level of >25%: Decrease by 5 units/kg
- Recommended for IV use only
- Product should be used within 4 hrs after reconstitution; discard partially used vials
[Outline]
- Hypersensitivity reactions, including anaphylaxis, have been reported following FXIII concentrate administration. Promptly discontinue the drug and provide appropriate emergency care, if signs or symptoms of anaphylaxis or hypersensitivity reactions occur
- Development of inhibitory antibodies against FXIII, which may manifest as an inadequate response to treatment has been reported in patients receiving the product. Consider performing an assay that measures FXIII inhibitory antibody concentrations if expected plasma FXIII activity levels are not attained or if breakthrough bleeding occurs while receiving prophylaxis
- In postmarketing surveillance, thromboembolic complications have been reported with the therapy. Use cautiously in pregnant women because of their hypercoagulable state and potential for increased risk of thromboembolic events
- This product is prepared from human plasma; products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Also, it may carry a risk of transmitting infectious agents such as viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. The risk of transmission may be reduced by screening plasma donors for prior exposure to certain viruses and by inactivating and/or removing certain viruses during manufacture. Despite these measures, these products may still contain human pathogenic agents, including those not yet known or identified. Discuss the risks and benefits of this product with the patient
- Monitor trough FXIII activity levels regularly during the treatment
Caution: Use cautiously in
Pregnancy Category:C
Breastfeeding: Safety unknown. Use only if clearly needed when treating nursing women.
