650 IU/1300 IU powder and liquid for injection, solution
voicing alfa
What VEYVONDI is and what it is used for
VEYVONDI contains the active substance vonicog alfa, a recombinant human von Willebrand factor (VFW). The drug behaves in the same way as the natural human von Willebrand factor (VWF) in the body. VWF is a carrier molecule for coagulation factor VIII and is involved in blood clotting, by making platelets stick to wounds so that the blood clots. Lack of VWF increases the tendency to bleed.
VEYVONDI is used to treat and control bleeding episodes and to prevent bleeding during surgical procedures in adult patients (18 years of age or older) diagnosed with von Willebrand disease. It is used when treatment with another drug, desmopressin, is not effective or cannot be given.
Von Willebrand disease is an inherited bleeding disorder caused by the absence or insufficient amount of von Willebrand factor. In patients with the disease, the blood does not clot normally, which leads to a longer bleeding time. Administration of the von Willebrand factor (VWF) makes it possible to correct von Willebrand factor deficiency.
What you need to know before using VEYVONDI
Do not use VEYVONDI
- if you are allergic to vonicog alfa or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to mouse or hamster proteins.
Consult a doctor if you are unsure.
Warnings and precautions
Talk to your doctor before using VEYVONDI.
There is a risk that you may have a hypersensitivity reaction (a severe, sudden allergic reaction ) when using VEYVONDI. Your doctor should inform you of early signs of serious allergic reactions, such as increased heart rate, rash, hives, hives, general itching, swelling of the lips and tongue, difficulty breathing, wheezing, tightness in the chest, fast heartbeat, stuffy nose, red eyes, general malaise, and dizziness. These can be early symptoms of a hypersensitivity reaction. If any of these symptoms occur, immediately stop the infusion one and contact a doctor. Severe symptoms, including difficulty breathing and dizziness, require immediate emergency treatment.
Patients who develop inhibitors
In some patients who receive the drug, inhibitors ( antibodies ) against VWF may form. The inhibitors can, especially at high levels, prevent the treatment from working as it should. You will be closely monitored for the development of such inhibitors.
- If you experience bleeding that cannot be controlled with VEYVONDI, tell your doctor immediately.
If the expected levels of VWF or factor VIII in plasma are not achieved with VEYVONDI according to the test results observed by your doctor, or if the bleeding is not properly controlled, it may be due to the presence of VWF or factor VIII antibodies. Your doctor will check this. You may need to increase the dose of VEYVONDI, or increase the dose of factor VIII, or even change to another medicine to control the bleeding. Do not increase the total dose of VEYVONDI to control bleeding without consulting your doctor.
If you have previously been treated with plasma-derived VWF concentrate, you may have a reduced response to VEYVONDI due to pre-existing antibodies. Your doctor may need to adjust your dose based on your lab results.
Thromboembolism and embolism
There is a risk of thrombotic events if you have risk factors that have been demonstrated clinically or in the laboratory. Therefore, your doctor will monitor you for early signs of thrombosis.
FVIII products may contain varying amounts of VWF. Therefore, an FVIII product administered in combination with VEYVONDI must be a pure FVIII product.
If you have previously had problems with blood clots or vessel narrowing (thromboembolic complications), you should tell your doctor immediately.
Children and young people
VEYVONDI is not approved for use by children and adolescents under the age of 18.
Other medicines and VEYVONDI
Tell your doctor if you are using, have recently used, or might be using other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine.
Driving ability and use of machinery
VEYVONDI is unlikely to affect your ability to drive or use machines.
VEYVONDI contains sodium
This medicinal product contains 5.2 mg sodium in each 650 IU vial and 10.4 mg sodium in each 1300 IU vial.
This corresponds to 2.2% of the recommended maximum daily intake of dietary sodium for adults with an estimated body weight of 70 kg and a dose of 80 IU/kg.
This should be taken into account if you have been prescribed a low-sodium diet.
How to use VEYVONDI
Treatment with VEYVONDI will be supervised by doctors experienced in treating patients with von Willebrand disease.
The doctor will calculate your dose of VEYVONDI (in international units or IU). Does one depends on:
- body weight
- where the bleeding is
- how extensive the bleeding is
- your clinical condition
- which surgery do you need
- VWF activity levels in the blood after surgery
- the severity of your illness.
The doctor can perform appropriate blood tests to make sure you have the right levels of von Willebrand factor. This is especially important if you are going to have major surgery.
Treatment of bleeding episodes:
The doctor will calculate the dose that is most suitable for you, how often you should receive VEYVONDI, and for how long.
For minor bleeding (e.g. epistaxis, bleeding in the mouth, heavy menstruation) each starting dose is usually 40 – 50 IU/kg and for major bleeding (severe or refractory epistaxis, heavy and frequent menstruation, gastrointestinal bleeding, trauma to the central nervous system, hemarthrosis or traumatic bleeding) each starting dose is 50-80 IU/kg. Loading doses (according to clinical need) are 40 – 50 IU/kg every 8 to 24 hours for minor bleeding as long as considered clinically necessary and for major bleeding 40 – 60 IU/kg for approximately 2 – 3 days.
Talk to your doctor if you feel that VEYVONDI is not working well enough. Your doctor performs appropriate laboratory tests to make sure you have the right levels of von Willebrand factor. If you use VEYVONDI at home, your doctor will make sure you have been shown how to infuse it and how much to use.
Prevention of bleeding in case of the elective surgery:
Within 3 hours before surgery, your doctor assesses FVIII: C levels to prevent heavy bleeding. If your FVIII level is not sufficient, your doctor may give you a dose of 40-60 IU/kg of VEYVONDI 12-24 hours ( preoperative dose ) before the elective surgical procedure to raise the FVIII levels to the target level (0.4 IU /ml for minor and at least 0.8 IU/ml for major procedures). Within 1 hour before surgery, you will receive a dose of VEYVONDI based on the evaluation 3 hours before surgery. The dose depends on the patient’s VWF and FVIII levels, the type of bleeding, and how severe the bleeding is expected to be.
How to get VEYVONDI
VEYVONDI is usually infused into a vein ( intravenously ) by a doctor or nurse. Detailed instructions for preparation and administration can be found at the end of this leaflet.
Use for children and adolescents
VEYVONDI is not approved for use by children and adolescents under the age of 18.
If you have used too much VEYVONDI
Always use this medicine as directed by your doctor. Consult a doctor if you are unsure. If you infuse more VEYVONDI than recommended, talk to your doctor as soon as possible. There is a risk of developing blood clots ( thrombosis ) at an unintentionally high dose.
If you forget to use VEYVONDI
- Do not infuse a double dose to make up for a missed dose.
- Take the next dose as planned and continue according to the doctor’s prescription.
If you stop using VEYVONDI
Do not stop using VEYVONDI without consulting your doctor.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You may have a severe allergic reaction to VEYVONDI.
If you get any of the following early symptoms of a serious allergic reaction, you must stop the infusion and contact a doctor immediately :
- rash or hives, general itching (over the whole body),
- tightness in the throat, pressure or pain in the chest,
- difficulty breathing, feeling faint, increased heart rate,
- dizziness, nausea, or fainting.
Side effects that have been reported with VEYVONDI as common (up to 1 in
10 patients) are nausea, vomiting, stinging or burning at the infusion site, chest discomfort, dizziness, vertigo, blood clots, flushing, itching, high blood pressure, muscle twitching, uncommon taste in the mouth, and increased heart rate.
How to store VEYVONDI
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 30 °C.
- Do not freeze.
- Store the vial in the outer carton. Light sensitive.
- The solution must not be stored in a refrigerator after preparation.
- The ready-made product must be used within 3 hours to avoid the risk of microbial contamination as the product does not contain any preservatives.
- The medicine is for single use only. Dispose of leftover solutions appropriately.
- Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is voicing alfa ( recombinant human von Willebrand factor).
VEYVONDI 650 IU powder and liquid for injection, solution
Each vial of powder contains nominally 650 international units (IU) of voicing alfa.
After reconstitution with 5 ml of solvent included, VEYVONDI contains approximately 130 IU per ml of voicing alfa.
VEYVONDI 1300 IU powder and liquid for injection, solution
Each vial of powder contains nominally 1300 international units (IU) of voicing alfa.
After reconstitution with 10 ml of solvent included, VEYVONDI contains approximately 130 IU per ml of voicing alfa.
Other ingredients are:
- Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80, and water for injections.
- See section 2, “VEYVONDI contains sodium”.
Appearance and package sizes of the medicine
VEYVONDI is a white-to-dark-white powder. After preparation, when the solution has been drawn into the syringe, it is clear, colorless, and free of flakes or foreign particles.
Each package of VEYVONDI 650 IU contains:
- powder in a glass vial with a rubber stopper
- 5 ml solvent in a glass vial with a rubber stopper
- a preparation device (Mix2Vial)
Each package of VEYVONDI 1300 IU contains:
- powder in a vial (type I glass) with a butyl rubber stopper
- 10 ml solvent in a vial (type I glass) with a rubber stopper (bromobutyl)
- a preparation device (Mix2Vial)
Marketing Authorisation Holder
Baxalta Innovations GmbH
Industriestraße 67
1221 Vienna
Austria
Phone: +44(0)1256 894 959
Email: medinfoEMEA@shire.com
Manufacturer
Takeda Manufacturing Austria AG
Industriestrasse 67
1221 Vienna
Austria