Prescribing Information

PRESCRIBING INFORMATION: Voncento^® (Human coagulation factor VIII/Von Willebrand factor complex) Please refer to the Summary of Product Characteristics (SPC) before prescribing.

Presentation: 500 IU / 1200 IU and 1000 IU / 2400 IU packs of powder and solvent for solution for injection / infusion. Indications: Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. Voncento can be used for all age groups. Dosage and Administration: On-demand treatment: Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis. An initial dose of 80 IU/kg VWF:RCo may be required, especially in patients with type 3. Long term prophylaxis: 25 - 40 IU VWF:RCo /kg body weight should be considered at a frequency of 1 to 3 times per week. In patients with gastrointestinal bleeds or menorrhagia, shorter dose intervals or higher doses may be necessary. The dose and duration of treatment will depend on the clinical status of the patient, as well as their VWF:RCo and FVIII:C plasma levels. Prevention of haemorrhage in case of surgery: for prevention of excessive bleeding during or after surgery administration should start 1 - 2 hours before the surgical procedure. An appropriate dose should be re-administered every 12 - 24 hours. The dose and duration of the treatment depend on the clinical status of the patient, the type and severity of the bleeding, and both VWF:RCo and FVIII:C levels. Treatment of bleeding in paediatric patients: Usually 40 - 80 IU/kg of VWF:RCo corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended. Prophylaxis treatment in patients aged 12 to 18 years: Dosing is based on the same guidelines as for adults. Prophylaxis treatment in patients under 12 years: a dose range of 40 – 80 IU VWF:RCo/kg body weight 1 to 3 times a week should be considered. See SmPC for further dosage information. Method of administration: The reconstituted preparation should be injected/infused slowly intravenously at a rate comfortable for the patient not exceeding 6 ml per minute. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Special Warnings & Precautions: Traceability: Name and batch number of the product administered should be recorded. Hypersensitivity: Allergic type hypersensitivity reactions are possible. If symptoms occur, patients should be advised to discontinue and contact their physician. Patients should be informed of the early signs of hypersensitivity. In case of shock, the current medical standards for shock treatment should be observed. Virus safety: Standard measures used to prevent infections from medicinal products prepared from human blood/plasma are considered effective for enveloped viruses such as HIV, HBV, HCV and the non-enveloped HAV viruses, but may be of limited value against non-enveloped viruses such as parvovirus B19. Appropriate vaccination (hepatitis A and B) should be considered for patients.

von Willebrand disease: There is a risk of occurrence of thrombotic events, particularly in patients with known risk factors. At risk patients must be monitored for early signs of thrombosis. Prophylaxis against venous thromboembolism should be instituted, according to the current recommendations. When using a FVIII-containing VWF product, the physician should be aware that continued treatment may cause an excessive rise in FVIII:C. which may increase the risk of thrombotic events. Plasma levels of FVIII:C should be monitored and antithrombotic measures considered. Neutralising antibodies(inhibitors) to VWF may develop. If the expected VWF:RCo activity plasma levels are not attained, or if bleeding is not controlled, an appropriate assay should be used to determine if a VWF inhibitor is present. In patients with high levels of inhibitor, therapy may not only be ineffective but also lead to anaphylactoid reactions and, other therapeutic options should be considered. Cardiovascular events: In patients with cardiovascular risk factors, therapy with FVIII may increase the cardiovascular risk. Catheter-related complications: If a central venous access device (CVAD) is required, risk of complications including local infections, bacteremia and catheter site thrombosis should be considered. Sodium content: 500 IU FVIII / 1200 IU VWF presentation contains up to 14.75 mg of sodium. 1000 IU FVIII / 2400 IU VWF presentation contains up to 29.50 mg of sodium. Paediatric population: The listed warnings and precautions apply both to adults and paediatrics. Pregnancy and Lactation: Administer only if clearly indicated and benefit outweighs risk. Undesirable Effects: Very common (≥1/10): headache, FVIII inhibition (PUPs). Common (≥1/100 to <1/10): hypersensitivity (including tachycardia, chest pain, chest discomfort and back pain), pyrexia. Uncommon (≥1/<1,000 to /1/100): FVIII inhibition (PTP), dysgeusia, thromboembolic event, liver function test abnormal. Not known: VWF inhibition. Refer to the SPC for details on full side effect profile and interactions. Marketing authorisation Number: Voncento 500/1200: PGLB 15036/0158 (EU/1/13/857/003), Voncento 1000/2400: PLGB 15036/0149 (EU/1/13/857/004) NHS Maximum Price: 500/1200 IU: £385.00; 1000/ 2400 IU: £770.00. Further information is available from: CSL Behring UK Limited, 4 Milton Road, Haywards Heath, West Sussex, RH16 1AH. Legal Category: POM. Date Prepared: Jan 2022. PI Approval Code: GBR-VCT-0100