Vonvendi

Vonvendi is a prescription medication used to treat and control bleeding episodes in patients with von Willebrand disease (VWD). This medication is also used to prevent excessive bleeding during and after surgery.

Vonvendi belongs to a group of drugs called recombinant protein treatments. These work by providing a protein that is needed for the blood to clot.

This medication is available in powder form to be mixed and be given directly into a vein (IV) by a healthcare professional.

Common side effects of Vonvendi include itching, nausea, and dizziness. 

Vonvendi is a prescription medication used to treat and control bleeding episodes in adults with von Willebrand disease (VWD). This medication is also used to prevent excessive bleeding during and after surgery.

VWD is an inherited bleeding disorder. Vonvendi is used to replace von Willebrand factor that is missing in people with von Willebrand disease. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vonvendi. See the "Drug Precautions" section.

Common side effects of Vonvendi include:

• itching
• nausea
• tingling or burning at the injection site
• chest discomfort
• dizziness
• hot flashes
• high blood pressure
• muscle twitching
• unusual taste
• increased heart rate 

This is not a complete list of Vonvendi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been reported by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Vonvendi including the following:

Blood Clots. Vonvendi may increase your risk of developing a blood clot, which could lead to pulmonary embolism (a clot in your lungs), stroke, or heart attack. Alert your doctor immediately if you have any of the following signs or symptoms:

• pain or swelling in your legs
• discoloration
• trouble breathing
• shortness of breath
• cough
• coughing up blood
• feeling faint or lightheaded
• chest pain
• discomfort in arms, shoulder, neck, or back
• nausea or vomiting
• numbness or weakness in the face, arm, or leg (especially on one side of the body)
• confusion
• trouble speaking
• dizziness
• severe headache

Hypersensitivity Reactions. Severe allergic reactions may occur with Vonvendi. Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing
• rash

Neutralizing Antibodies. Your body can make neutralizing antibodies which inhibit von Willebrand factor and/or factor VIII from working correctly. Your doctor will perform blood tests to check your von Willebrand factor activity and the presence of any inhibitors. If high levels of inhibitors are detected, Vonvendi may not work for you.

Laboratory Monitoring. In addition to checking for neutralizing antibodies, your doctor will also check your von Willebrand factor levels to make sure they are not too high, which could increase your risk of blood clots.

Do not take Vonvendi if you are allergic to Vonvendi or to any of its ingredients, or are allergic to mice or hamsters.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vonvendi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vonvendi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Vonvendi or to any of its ingredients
• have any current or previous medical conditions
• have any allergies, especially to mice or hamsters
• are breastfeeding or plan to breastfeed
• are pregnant or plan to become pregnant
• have been told that you have inhibitors to von Willebrand factor
• have been told that you have inhibitors to blood coagulation factor VIII

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

No studies have been done in pregnant women or animals with Vonvendi, therefore it is unknown if Vonvendi can be harmful to an unborn baby or affect a woman's ability to become pregnant. Vonvendi should be given to pregnant women only if clearly needed.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vonvendi crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Vonvendi.

Use Vonvendi exactly as prescribed.

Vonvendi comes in powder form to be mixed and be given directly into a vein (IV) by a healthcare professional at a hemophilia treatment center or at your physician's office. Vonvendi may also be infused in your home if you are trained by your healthcare provider or by the hemophilia treatment center.

Your first dose of Vonvendi for each bleeding episode may be given with a recombinant factor VIII (factor VIII not produced from blood plasma). The length of time it is to be given is based on the extent and location of the bleeding episode, as determined by your healthcare provider.

If you are infusing Vonvendi at home, always follow specific instructions given to you by your doctor on how to infuse Vonvendi. Call your doctor right away if your bleeding does not stop after taking Vonvendi.

If Vonvendi is given to prevent excessive bleeding during and after surgery, a dose of Vonvendi may be given 12 to 24 hours prior to surgery. Your health care provider will monitor your levels and determine if you need another dose before surgery. In addition, your health care provider will also determine if you are in need of recombinant factor VIII (factor VIII not produced from blood plasma).

Use this medication exactly as prescribed by your doctor.

The dose your doctor recommends may be based on the following:

• your weight
• the location and extent of your bleeding episode
• how you respond to this medication
• your medical history

Treatment and Control of Bleeding Episodes

The recommended dose for a minor bleed (nosebleed that is readily managed, bleeding from the mouth, or a heavy bleed associated with your menstrual cycle) is 40 to 50 IU/kg as an initial dose, followed by 40 to 50 IU/kg every 8 to 24 hours as clinically required, determined by your healthcare provider.  

The recommended dose for a major bleed (severe nosebleed or menstrual cycle bleed that does not easily stop, stomach bleed, bleeding in your joint spaces, bleeding from a traumatic injury, or trauma to your central nervous system) is 50 to 80 IU/kg as an initial dose, followed by 40 to 60 IU/kg every 8 to 24 hours for around 2-3 days as clinically required, determined by your healthcare provider.

Administering recombinant factor VIII along with Vonvendi may be required to control bleeding. Your doctor will determine if you need factor VIII and calculate your dose based on your dose of Vonvendi. If you are going to receive recombinant factor VIII, it should be infused within 10 minutes of completing the infusion of Vonvendi. 

Prevent Excessive Bleeding During and After Surgery

A dose of Vonvendi may be given 12 to 24 hours prior to surgery to allow the endogenous factor VIII levels to increase to at least 30 IU/dL (minor surgery) or 60 IU/dL (major surgery). 

Your health care provider will monitor your levels and determine if you need another dose before surgery or if you are in need of recombinant factor VIII (factor VIII not produced from blood plasma).

For emergency surgery, the dose will be based on your levels and if not available, your health care provider will use your weight to calculate your dose. 

If you take too much Vonvendi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Vonvendi is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Vonvendi in the original box and keep away from light.
• Store Vonvendi in the refrigerator 2°C to 8°C (36°F to 46°F) or store at room temperature up to 30°C (86°F) for up to 12 months. Do not freeze.

If you store it at room temperature:

• Write the date it is taken out of the refrigerator on the box
• Do not put it back in the refrigerator
• Do not use after 12 months from the date noted on the box or after the expiration date.

Storing the mixed (reconstituted) product:

• After mixing dry product with supplied sterile water, store the product at room temperature not to exceed 27 °C (81°F) for up to three hours. Discard after 3 hours. 

Keep this and all medicines out of the reach of children.

Keep all appointments with your doctor and the laboratory.