VEYVONDI 1300 IU powder and solvent for solution for injection

VEYVONDI 650 IU powder and solvent for solution for injection

VEYVONDI 1 300 IU powder and solvent for solution for injection

vonicog alfa

VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF). It behaves in the same way as natural human von Willebrand factor (VWF) in the body. VWF is the carrier molecule for coagulation factor VIII and is involved in blood clotting making platelets stick to wounds and so helps to form a blood clot. Lack of VWF increases the tendency to bleed.

VEYVONDI is used to prevent and treat bleeding episodes, including bleeding during surgery in adult patients (aged 18 years and older) with von Willebrand disease. It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.

VEYVONDI is used to treat bleeding episodes in children aged less than 18 years with von Willebrand disease. It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.

Von Willebrand disease is an inherited bleeding disorder caused by the lack or an insufficient amount of von Willebrand factor. In patients with the disease the blood does not clot normally leading to a prolonged bleeding time. Administration of von Willebrand factor (VWF) allows for correction of von Willebrand factor deficiency.

Your treatment with VEYVONDI will be supervised by a doctor who is experienced in the care of patients with von Willebrand disease.

Your doctor will calculate your dose of VEYVONDI (in international units or IU). The dose depends on:

• body weight,
• the site of the bleeding,
• intensity of the bleeding,
• your clinical condition,
• the required surgery,
• the VWF activity levels in your blood after surgery,
• the severity of your disease.

Your doctor may test your blood to make sure that you have adequate levels of von Willebrand factor. This is particularly important if you are having major surgery.

Treatment of bleeding episodes

Your doctor will calculate the dose that is most appropriate for you or your child, how often you or your child should receive VEYVONDI and for how long.

For minor bleeding (e.g. nose-bleed, oral bleeding, menorrhagia), each initial dose is usually 40 to 50 IU/kg and for major bleeding (severe or refractory nose-bleed, menorrhagia, gastrointestinal bleeding, central nervous system trauma, haemarthrosis, or traumatic haemorrhage), each initial dose is 50 to 80 IU/kg. Subsequent doses (as clinically required) are 40 to 50 IU/kg every 8 to 24 hours for minor bleeds as long as deemed clinically necessary and for major bleeds 40 to 60 IU/kg for approximately 2-3 days.

If you feel that VEYVONDI is not working well enough, talk to your doctor. Your doctor will perform tests to make sure that you have adequate levels of von Willebrand factor. If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use.

Prevention of bleeding in case of elective surgery

For prevention of excessive bleeding your doctor will assess the FVIII:C levels within 3 hours before surgery. If your FVIII level is inadequate your doctor may give you a dose of 40-60 IU/kg VEYVONDI 12-24 hours (pre-operative dose) prior to initiating elective surgery in order to raise FVIII levels to the target level (0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery). Within 1 hour prior to surgery, you will receive a dose of VEYVONDI based on the assessment 3 hours before surgery. The dose depends on VWF and FVIII levels of the patient, the type and severity of the expected bleeding.

Prophylaxis treatment

The usual starting dose for long term prophylaxis against bleeding episodes is 40 to 60 IU/kg twice weekly. The dose can be adjusted to a maximum of 80 IU/kg one to three times per week, depending on your condition and how well VEYVONDI is working for you. Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everybody gets them.

You can have a serious allergic reaction to VEYVONDI.

You must stop the infusion and contact your doctor immediately if you or your child have any of the following early symptoms of severe allergic reactions:

• rash or hives, itching all over the body,
• tightness of the throat, chest pain or chest tightness,
• difficulty breathing, light headedness, fast heartbeat,
• dizziness, nausea or fainting.

The following side effects have been reported with VEYVONDI:

Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• nausea
• vomiting
• dizziness
• vertigo
• itching
• high blood pressure

Uncommon (may affect up to 1 in 100 people)

• tingling or burning at infusion site
• chest discomfort
• blood clots
• hot flushes
• muscle twitching
• unusual taste
• increased heart rate

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.
• Store below 30 °C.
• Do not freeze.
• Store in the original package in order to protect from light.
• Do not refrigerate the solution after preparation.
• Use the reconstituted product within 3 hours to avoid the risk of microbial contamination, because the product does not contain preservatives.
• This medicine is for single use only. Discard any unused solution appropriately.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

General instructions

Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation. Do not use after the expiry date stated on the labels and carton.

Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure. Wash your hands and put on clean exam gloves (the use of gloves is optional).

Use the reconstituted product (after mixing the powder with the supplied water) as soon as possible and within three hours. You can store the reconstituted product at room temperature not to exceed 25 °C for up to three hours. Reconstituted product should not be refrigerated. Discard after three hours.

Ensure that the VEYVONDI powder vial and the water for injections (solvent) are at room temperature prior to preparation.

Use plastic syringes with this product because proteins in the product tend to stick to the surface of glass syringes.

Do not mix VEYVONDI with other medicinal products except for octocog alfa (ADVATE).

Instructions for reconstitution

Steps

1 Remove the caps from the VEYVONDI powder and solvent vials to expose the centre of the rubber stoppers.
2 Disinfect each stopper with a separate sterile alcohol swab (or other suitable sterile solution suggested by your doctor or haemophilia treatment centre) by wiping the stopper for several seconds. Allow the rubber stoppers to dry. Place the vials on a flat surface.
3 Open the Mix2Vial device package by completely peeling away the lid, without touching the inside of the package. Do not remove the Mix2Vial device from the package.
4 Turn the package with the Mix2Vial device upside down and place it over the top of the solvent vial. Firmly insert the blue plastic spike of the device into the centre of the solvent vial stopper by pushing straight down. Grip the package at its edge and lift it off the Mix2Vial device. Be careful not to touch the clear plastic spike. The solvent vial now has the Mix2Vial device connected to it and is ready to be connected to the VEYVONDI vial.
5 To connect the solvent vial to the VEYVONDI vial, turn the solvent vial over and place it on top of the vial containing VEYVONDI powder. Fully insert the clear plastic spike into the VEYVONDI vial stopper by firmly pushing straight down. This should be done right away to keep the liquid free of germs. The solvent will flow into the VEYVONDI vial by vacuum. Check that all the solvent has transferred. Do not use if vacuum has been lost and the solvent does not flow into the VEYVONDI vial.
6 Gently and continuously swirl the connected vials or allow the reconstituted product to stand for 5 minutes then gently swirl to ensure the powder is completely dissolved. Do not shake. Shaking will adversely affect the product. Do not refrigerate after reconstitution.
7 Disconnect the two sides of the Mix2Vial from each other by holding the clear plastic side of the Mix2Vial device attached to the VEYVONDI vial with one hand and the blue plastic side of the Mix2Vial device attached to the solvent vial with the other hand. Turn the blue plastic side counterclockwise and gently pull the two vials apart. Do not touch the end of the plastic connector attached to the VEYVONDI vial containing the dissolved product. Place the VEYVONDI vial on a flat work surface. Discard the empty solvent vial.
8 Draw air into the empty, sterile disposable plastic syringe by pulling back on the plunger. The amount of air should equal the amount of reconstituted VEYVONDI that you will withdraw from the vial.
9 Leaving the VEYVONDI vial (containing the reconstituted product) on your flat work surface, connect the syringe to the clear plastic connector and turn the syringe clockwise.
10 Hold the vial with one hand and use the other hand to push all the air from the syringe into the vial
11 Flip connected syringe and VEYVONDI vial so the vial is on top. Be sure to keep the syringe plunger pressed in. Draw the VEYVONDI into the syringe by pulling plunger back slowly.
12 Do not push and pull solution back and forth between syringe and vial. Doing so may harm the medicine. When ready to infuse, disconnect the syringe by turning it counterclockwise. Inspect the syringe visually for particulate matter; the solution should be clear and colourless. If flakes or particles are seen, do not use the solution and notify your doctor.
13 If you need more than one vial of VEYVONDI to make up your dose:

• Leave the syringe attached to the vial until an additional vial is prepared.
• Use the reconstitution steps above (2 to 8) to prepare the additional vial of VEYVONDI using a fresh Mix2Vial for each vial.

14 The contents of two vials may be drawn into a single syringe. NOTE: When pushing air into a second vial of VEYVONDI to be pooled into a syringe, position the vial and connected syringe so that the vial is on top.

Instructions for administration

Inspect the prepared solution in the syringe for particulate matter and discolouration prior to administration (the solution should be clear, colourless and free from particles). It is not uncommon for a few flakes or particles to remain in the product vial after reconstitution. The filter included in the Mix2Vial device removes those particles completely. Filtration does not influence dose calculations. The solution in the syringe should not be used if it is cloudy or contains flakes or particles after filtration.

1. Attach the infusion needle to a syringe containing VEYVONDI solution. For comfort, a winged (butterfly) infusion set is preferred. Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle.
2. Apply a tourniquet and get the infusion site ready by wiping the skin well with a sterile alcohol swab (or other suitable sterile solution suggested by your doctor or haemophilia treatment centre).
3. Insert the needle into the vein and remove the tourniquet. Slowly infuse VEYVONDI. Do not infuse any faster than 4 mL per minute. Disconnect the empty syringe. If your dose requires multiple syringes, attach and administer each additional syringe of VEYVONDI one at a time.
Note:
Do not remove butterfly needle until all syringes have been infused and do not touch the Luer port that connects to the syringe.
If recombinant factor VIII has been prescribed, administer recombinant factor VIII within 10 minutes after infusion of VEYVONDI has been completed.
4. Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.

In case large volumes of VEYVONDI are required, it is possible to pool two vials of VEYVONDI together. The contents of each reconstituted product of VEYVONDI can be drawn in a single syringe. However, in these cases the initially reconstituted solution of VEYVONDI should not be diluted any further.

The solution should be slowly administered intravenously not exceeding 4 mL/min.

Do not recap the needle. Place the needle, syringe, and empty VEYVONDI and solvent vial(s) in a hard-walled sharps container for proper disposal. Do not dispose of these supplies in ordinary household trash.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.