Drug Detail:Factor xiii a-subunit (recombinant) (monograph) (Tretten)
Drug Class:
Usual Adult Dose for Factor XIII Deficiency
CORTIFACT(R):
Initial dose: 40 international units/kg intravenously
Maximum rate: 4 mL/min
- Adjust dose up or down 5 international units/kg to maintain 5 to 20% trough factor XIII levels.
Routine prophylaxis: administer every 28 days
Perioperative management of surgical bleeding:
- Individualize dose based on factor XIII activity level, type of surgery, and clinical response.
- Monitor factor XIII levels during and after surgery.
- Examples of dose adjustment for peri-operative management, based on patient's last prophylactic dose:
- Last dose within 7 days: additional dose may not be needed
- Last dose 8 to 21 days ago: additional full or partial dose may be needed based on factor XIII activity level
- Last dose 21 to 28 days ago: full prophylactic dose.
TRETTEN(R):
Routine prophylaxis:
Initial dose: 35 international units/kg intravenously
Maximum rate: 1 to 2 mL/min
- Consider dose adjustment if adequate coverage is not achieved at the initial dose.
- Not for use in congenital factor XIII B-subunit deficiency.
Usual Pediatric Dose for Factor XIII Deficiency
CORTIFACT(R):
Initial dose: 40 international units/kg intravenously
Maximum rate: 4 mL/min
- Adjust dose up or down 5 international units/kg to maintain 5 to 20% trough factor XIII levels.
Routine prophylaxis: administer every 28 days
Perioperative management of surgical bleeding:
- Individualize dose based on factor XIII activity level, type of surgery, and clinical response.
- Monitor factor XIII levels during and after surgery.
- Examples of dose adjustment for peri-operative management, based on patient's last prophylactic dose:
- Last dose within 7 days: additional dose may not be needed
- Last dose 8 to 21 days ago: additional full or partial dose may be needed based on factor XIII activity level
- Last dose 21 to 28 days ago: full prophylactic dose.
TRETTEN(R):
Routine prophylaxis:
Initial dose: 35 international units/kg intravenously
Maximum rate: 1 to 2 mL/min
- Consider dose adjustment if adequate coverage is not achieved at the initial dose.
- Not for use in congenital factor XIII B-subunit deficiency.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
CORTIFACT(R):
Dose adjustment using Berichrom Activity Assay:
One trough level under 5%: increase by 5 international units/kg
Trough level 5 to 20%: no change
Two trough levels over 20%: decrease by 5 international units/kg
One trough level over 25%: decrease by 5 international units/kg
Precautions
CONTRAINDICATIONS:
- Anaphylactic or severe systemic reactions to human plasma-derived products
- Hypersensitivity to any of the ingredients
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
