Factor VIII + Von Willebrand factor


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A Dosage and duration is individualised based on preparation used, severity of factor VIII deficiency, extent and location of bleeding, presence of inhibitors, and patient’s clinical status. Dose may be titrated as needed based on clinical response. Generally, administration of 1 IU/kg of factor VIII increases circulating factor VIII concentrations by 2% (approx 2 IU/dL). Calculated dosage is adjusted to the actual vial size. Refer to detailed product guideline. Treatment of haemorrhagic episodes in patients with von Willebrand disease; Prophylaxis of haemorrhagic episodes during and after surgery in patients with von Willebrand disease Dosage and duration is individualised based on preparation used, type of von Willebrand disease, extent and location of bleeding, and patient’s clinical status. Refer to detailed product guideline.
Dosage Details
Intravenous
Treatment and prophylaxis of haemorrhagic episodes in patients with haemophilia A
Adult: Available preparations:
Factor VIII 250 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 500 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 1,000 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 1,500 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 2,000 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 250 IU and von Willebrand factor:RCo 600 IU
Factor VIII 500 IU and von Willebrand factor:RCo 1200 IU
Factor VIII 1000 IU and von Willebrand factor:RCo 2400 IU

Dosage and duration is individualised based on preparation used, severity of factor VIII deficiency, extent and location of bleeding, presence of inhibitors, and patient’s clinical status. Dose may be titrated as needed based on clinical response. Generally, administration of 1 IU/kg of factor VIII increases circulating factor VIII concentrations by 2% (approx 2 IU/dL). Calculated dosage is adjusted to the actual vial size. Refer to detailed product guideline.
Child: Generally based on same guidelines as for adults; according to body weight. Refer to detailed product information.

Intravenous
Treatment of haemorrhagic episodes in patients with von Willebrand disease
Adult: Available preparations:
Factor VIII 250 IU and von Willebrand factor 600 IU
Factor VIII 500 IU and von Willebrand factor 1,200 IU
Factor VIII 1,000 IU and von Willebrand factor 2,400 IU
Factor VIII 500 IU and von Willebrand factor:RCo 500 IU
Factor VIII 1,000 IU and von Willebrand factor:RCo 1,000 IU

Dosage and duration is individualised based on preparation used, type of von Willebrand disease, extent and location of bleeding, and patient’s clinical status. Refer to detailed product guideline.
Child: Generally based on same guidelines as for adults; according to body weight. Refer to detailed product information.

Intravenous
Prophylaxis of haemorrhagic episodes during and after surgery in patients with von Willebrand disease
Adult: Available preparations:
Factor VIII 250 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 500 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 1,000 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 1,500 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 2,000 IU and von Willebrand factor:RCo (ratio varies by lot)
Factor VIII 250 IU and von Willebrand factor:RCo 600 IU
Factor VIII 500 IU and von Willebrand factor:RCo 1,200 IU
Factor VIII 1,000 IU and von Willebrand factor:RCo 2,400 IU
Factor VIII 500 IU and von Willebrand factor:RCo 500 IU
Factor VIII 1,000 IU and von Willebrand factor:RCo 1,000 IU

Dosage and duration is individualised based on preparation used, type of von Willebrand disease, extent and location of bleeding, and patient’s clinical status. Refer to detailed product guideline.
Child: Generally based on same guidelines as for adults; according to body weight. Refer to detailed product information.
Reconstitution
Refer to individual product labelling for specific details. Use sterile filter transfer set provided by the manufacturer prior to administration.
Contraindications
Hypersensitivity.
Special Precautions
May carry a risk of transmitting infectious agents (e.g. viruses, Creutzfeldt-Jakob disease agents). Patient with risk factors for thromboembolic events (e.g. female, high concentrations of factor VIII, long-term therapy, obesity, cancer), risk factor for CV disease. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reaction (e.g. anaphylaxis), antibody formation, thromboembolic events, intravascular haemolysis, postoperative pain, inj site bleeding, oedema.
Cardiac disorders: Chest tightness.
Gastrointestinal disorders: Nausea.
General disorders and administration site conditions: Fatigue, fever, chills.
Musculoskeletal and connective tissue disorders: Arthralgia.
Respiratory, thoracic and mediastinal disorders: Respiratory distress.
Skin and subcutaneous tissue disorders: Rash, urticaria, pruritus.
Vascular disorders: Epistaxis.
MonitoringParameters
Monitor vital signs, BP, cardiac status, and CNS status during and after therapy. Measure trough coagulation factor levels at baseline, on each dosage adjustment, and thereafter, at least 1-2 times daily when desired levels are achieved. Monitor for signs and symptoms of hypersensitivity, bleeding, plasma concentrations (e.g. AHF, VWF, antibody inhibitors), coagulation parameters (e.g. haematocrit) prior to and at regular intervals during treatment. Perform assays to determine presence of factor VIII inhibitors.
Action
Description: Factor VIII is an important cofactor in the activation of factor X leading to the formation of thrombin and fibrin. It is used as a replacement therapy to enable temporary correction of the factor deficiency and bleeding tendencies.
Von Willebrand factor is a factor VIII stabiliser carrier protein that promotes platelet adhesion and aggregation on damaged vascular endothelium to form a clot.
Synonym: antihaemophilic factor/von Willebrand factor complex.
Onset: Immediate.
Duration: Shortening of bleeding time: <6 hours; presence of von Willebrand factor multimers: ≥24 hours.
Pharmacokinetics:
Absorption: Factor VIII: Time to peak plasma concentration: 1-1.5 hours.
Von Willebrand factor: Time to peak plasma concentration: Approx 50 minutes.
Excretion: Factor VIII: Terminal half-life: 12 hours (range: 8-28 hours).
Von Willebrand factor: Terminal half-life: 10 hours (range: 3-49 hours).
Storage
Store at or below 25°C. Do not freeze. Protect from light. Refer to individual product labelling for specific details.
MIMS Class
ATC Classification
B02BD06 - von Willebrand factor and coagulation factor VIII in combination ; Belongs to the class of blood coagulation factors. Used in the treatment of hemorrhage.
Disclaimer: This information is independently developed by MIMS based on Factor VIII + Von Willebrand factor from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
  • Haemate P
  • Wilate
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