Factor IX

Generic name
Factor IX
Brand name
ATC Code
B02BD04
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

There are only a few studies on the pharmacokinetics of coagulation products in children. Some studies have shown that the half-life of coagulation factor concentrate in young children may be two to four hours shorter than in adult haemophilia patients (18-24 hours). This is probably due to the difference in plasma volume and body composition, which affects clearance and shortens the half-life.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Go to:

MILD BLEEDING (incipient haemarthrosis, nasal and gingival bleeding, haematuria)
  • Intravenous
    • Term neonate
      • 30 IU/kg/dose, once only.

      • Initial target plasma concentration: 0.3 IU/ml

    • 1 month up to 18 years
      • 30 IU/kg/dose, once only.

      • Initial target plasma concentration: 0.3 IU/ml
SEVERE BLEEDING (severe joint bleeding with mobility restrictions, muscular bleeding in the upper arm and forearm, calf and iliopsoas muscle and severe trauma without manifest bleeding)
  • Intravenous
    • Term neonate
      • Initial dose: 50 IU/kg/dose, once only.
      • Maintenance dose: 25 IU/kg/day in 1 dose

      • Initial target plasma concentration: 0.5 IU/ml
        Target plasma concentration for intermittent administration: > 0.25 IU/ml

    • 1 month up to 18 years
      • Initial dose: 50 IU/kg/dose, once only.
      • Maintenance dose: 25 IU/kg/day in 1 dose

      • Initial target plasma concentration: 0.5 IU/ml
        Target plasma concentration for intermittent administration: > 0.25 IU/ml
LIFE-THREATENING BLEEDING (cranial trauma, bleeding in the digestive tract, abdominal trauma, bleeding that threatens the respiratory tract)
  • Intravenous
    • Term neonate
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: > 0.5 IU/ml

    • 1 month up to 18 years
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: > 0.5 IU/ml
MILD CRANIAL TRAUMA (fall from < 50 cm height, light blow to the head)
  • Intravenous
    • Term neonate
      • 100 IU/kg/dose, once only.

      • Initial target plasma concentration: 1.0 IU/ml

    • 1 month up to 18 years
      • 100 IU/kg/dose, once only.

      • Initial target plasma concentration: 1.0 IU/ml
MODERATELY SEVERE CRANIAL TRAUMA (fall from > 50 cm height/step, hard blow to the head)
  • Intravenous
    • Term neonate
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: 0.5-1.0 IU/ml (2-3 days)

    • 1 month up to 18 years
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: 0.5-1.0 IU/ml (2-3 days)
SEVERE CRANIAL TRAUMA (concussion or brain contusion)
  • Intravenous
    • Term neonate
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: 0.5-1.0 IU/ml (3-10 days)

    • 1 month up to 18 years
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: 0.5-1.0 IU/ml (3-10 days)
INTRACRANIAL BLEEDING
  • Intravenous
    • Term neonate
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: 0.5-1.0 IU/ml (10 days or more)

    • 1 month up to 18 years
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 1 dose

      • Initial target plasma concentration: 1.0 IU/ml
        Target plasma concentration for intermittent administration: 0.5-1.0 IU/ml (10 days or more)
Substitution treatment in procedures in moderately severe to severe haemophilia
  • Intravenous
    • Term neonate
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: first maintenance dose 24 hours after initial dose 50 IU/kg/day in 1 dose

      • Depending on the trough levels. Target values:
        Day 1: 0.8-1.0 IU/ml
        Days 2-5: 0.5-0.8 IU/ml
        Day > 6: 0.3-0.5 IU/ml

    • 1 month up to 18 years
      • Initial dose: 100 IU/kg/dose, once only.
      • Maintenance dose: first maintenance dose 24 hours after initial dose 50 IU/kg/day in 1 dose

      • Depending on the trough levels. Target values:
        Day 1: 0.8-1.0 IU/ml
        Days 2-5: 0.5-0.8 IU/ml
        Day > 6: 0.3-0.5 IU/ml
Prophylaxis for bleeding
  • Intravenous
    • Term neonate
      • 30 - 50 IU/kg/dose Twice a week.
    • 1 month up to 18 years
      • 30 - 50 IU/kg/dose Twice a week.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

VITAMIN K AND OTHER HEMOSTATICS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Vitamin K
B02BA01
Fibrinogen
B02BB01
Local hemostatics
B02BC30
Blood coagulation factors
B02BD08
B02BD02
B02BD01
Other systemic hemostatics
B02BX05
B02BX06
B02BX04
Blood coagulation factors
B02BD08
B02BD02
B02BD01

Reference

  1. Nederlandse Vereniging van Hemofiliebehandelaars (NVHB)., Richtlijn Diagnostiek en behandeling van hemofilie en aanverwante hemostasestoornissen, 2009, 29-30; 59

Changes

Therapeutic Drug Monitoring


Overdose