Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Factor VIII

Generic name
Factor VIII
Brand name
ATC Code
B02BD02

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 (8-15 hours). This is probably due to the difference in plasma volume and body composition, which affects clearance and shortens the half-life.

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

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Available formulations

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Dosages

MILD BLEEDING (incipient haemarthrosis, nasal and gingival bleeding, haematuria)
  • Intravenous
    • 0 years up to 18 years
      [1]
      • 15 IU/kg/dose, once only.

      • Initial target plasma concentration: 0.3 IU/ml
        Coagulation factors are only supplied on a haematologist’s prescription.
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
    • 0 years up to 18 years
      [1]
      • Initial dose: 25 IU/kg/dose, once only.
      • Maintenance dose: 25 IU/kg/day in 2 doses.

      • 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
    • 0 years up to 18 years
      • Initial dose: 50 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 2 doses.

      • 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
    • 0 years up to 18 years
      [1]
      • 50 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
    • 0 years up to 18 years
      [1]
      • Initial dose: 50 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 2 doses.

      • 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
    • 0 years up to 18 years
      [1]
      • Initial dose: 50 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 2 doses.

      • 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
    • 0 years up to 18 years
      [1]
      • Initial dose: 50 IU/kg/dose, once only.
      • Maintenance dose: 50 IU/kg/day in 2 doses.

      • 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
    • 0 years up to 18 years
      [1]
      • Initial dose: 50 IU/kg/dose, once only.
      • Maintenance dose: first maintenance dose 12 hours after initial dose 50 IU/kg/day in 2 doses.

      • 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
    • 0 years up to 18 years
      [1]
      • 25 - 40 IU/kg/dose 2-3 times a week.
Bleeding in patients with inhibitors in haemophilia A and B and Von Willebrand’s disease
  • Intravenous
    • 0 years up to 18 years
      [1]
      • Initial dose: Low-responding inhibitors: 100 - 200 IU/kg/dose, once only. Maintenance dose: Further dosage dependent on the concentrations of factor VIII.

      • Prior to treatment, neutralization of the inhibitor by a bolus injection is needed:
        Dosage calculation: (twice the bodyweight in kg) x 80 x (100 minus haematocrit in %) x (inhibitory titre in BU/ml) divided by 100

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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.

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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.

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Interactions

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

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Vitamin K
B02BA01
Blood coagulation factors
B02BD04
Blood coagulation factors
B02BD04

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Reference

  1. Nederlandse Vereniging van Hemofiliebehandelaars (NVHB), Richtlijn Diagnostiek en behandeling van hemofilie en aanverwante hemostasestoornissen, 2009, ISBN: 978-90-8523-195-0, 29-30; 59

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Changes

Changes