Usual Adult Dose for Factor X Deficiency

On-demand Treatment and Control:
25 international units/kg IV infusion at the first sign of bleeding; repeat every 24 hours until bleeding stops.

Maximum dose: 60 international units/kg/day

Perioperative Management:
Pre-surgery:

• Calculate and administer dose needed to increase Factor X levels to 70 to 90 international units/dL (required dose [international units] = body weight [kg] x desired Factor X increase [international units/dL] x 0.5).

Post-surgery:

• Repeat pre-surgery dose as needed to maintain Factor X levels at a minimum of 50 international units/dL until patient is no longer at risk of bleeding due to surgery.

Maximum dose: 60 international units/kg/day

Comments: Measure post-infusion Factor X levels before and after surgery.

Use: Perioperative bleeding management in patients with mild hereditary Factor X deficiency.

Usual Pediatric Dose for Factor X Deficiency

12 YEARS OR OLDER:
On-demand Treatment and Control:
25 international units/kg IV infusion at the first sign of bleeding; repeat every 24 hours until bleeding stops.

Maximum dose: 60 international units/kg/day

Perioperative Management:
Pre-surgery:

• Calculate and administer dose needed to increase Factor X levels to 70 to 90 international units/dL (required dose [international units] = body weight [kg] x desired Factor X increase [international units/dL] x 0.5).

Post-surgery:

• Repeat pre-surgery dose as needed to maintain Factor X levels at a minimum of 50 international units/dL until patient is no longer at risk of bleeding due to surgery.

Maximum dose: 60 international units/kg/day

Comments: Measure post-infusion Factor X levels before and after surgery.

Use: Perioperative bleeding management in patients with mild hereditary Factor X deficiency.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For IV use only.
• Administer at a rate of 10 mL/min, not to exceed 20 mL/min.

Storage requirements:

• Protect from light.
• Store at room temperature or in a refrigerator; do not freeze.
• Use within 1 hour of reconstitution.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General: Perioperative bleeding management in major surgery patients with moderate and severe hereditary Factor X deficiency has not been studied.

Monitoring:

• Monitor Factor X activity by performing a validated test (e.g., one-stage clotting assay).
• Monitor all patients for inhibitor formation.

Patient advice:

• Advise patients to immediately report early signs and symptoms of hypersensitivity (e.g., angioedema, infusion site inflammation, chills, cough, dizziness, fever, flushing, generalized urticaria, headache, hives, hypotension, lethargy, musculoskeletal pains, nausea, pruritus, rash, restlessness, tachycardia, chest tightness, tingling, vomiting, wheezing).
• Advise patients to seek medical attention if they lack clinical response to this drug as this could be a sign of inhibitor formation.
• Advise patients to report any symptoms that concern them, especially those related to infection (e.g., fever), as this drug could potentially transmit disease.