Factor VIII + Von Willebrand factor: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Pregnancy Category (US FDA)

IV: C

Monitoring Parameters

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:
Mechanism of Action: 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

Haemostatics

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.

References

Alphanate (Grifols USA, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 21/06/2018.

Anon. Antihemophilic Factor/von Willebrand Factor Complex (Human). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 18/06/2018.

Buckingham R (ed). Factor VIII. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 18/06/2018.

Buckingham R (ed). Von Willebrand Factor. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 19/06/2018.

Humate-P (CSL Behring GmbH). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 18/06/2018.

Wilate Powder for Solution (Octapharma USA Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 21/06/2018.

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