Overview: Vonvendi is an injection used to prevent and treat bleeding episodes in people with von Willebrand disease. It helps the body form blood clots better. Common side effects include headache, nausea, vomiting, dizziness, and itching. Get help right away if you have trouble breathing, fast or abnormal heartbeat, chest pain or pressure, sudden weakness on one side of the body, trouble speaking, vision problems, or uncontrollable bleeding.
Uses
What is Vonvendi used for?
Vonvendi (von Willebrand factor, recombinant) is commonly used in people with von Willebrand disease (VWD) to prevent and treat bleeding episodes.
Vonvendi may also be used for other conditions as determined by your health care provider.
How does Vonvendi work (mechanism of action)?
Vonvendi helps your body form blood clots by replacing your body’s von Willebrand factor (VWF) that may be missing or not working as well due to von Willebrand disease. Vonvendi also helps your own blood coagulation (clotting) factor VIII work better. Both VWF and factor VIII are important for forming blood clots.
How is Vonvendi supplied (dosage forms)?
Vonvendi is available in an injectable form in single-dose vials.
How should I store Vonvendi?
Vonvendi may be given by a health care provider in a hospital or clinic. If you will store Vonvendi at home, follow the instructions given by your health care provider.
Side Effects
What are the most common side effects of Vonvendi?
The most common side effects of Vonvendi are listed below. Tell your health care provider if you have any of these side effects that bother you.
- Headache
- Nausea and vomiting
- Dizziness
- Itching
There may be other side effects of Vonvendi that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Vonvendi?
While less common, the most serious side effects of Vonvendi are described below, along with what to do if they happen.
Severe Allergic Reactions and Infusion Reactions. Vonvendi may cause allergic reactions or other reactions when it is given to you (infusion reactions), which can be serious. Stop using Vonvendi and get help right away if you have any of the following symptoms.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives, which can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
- Lack of energy
- Numbness, tingling, or burning in your arms, feet, or face
- Restlessness
- Blurry vision
Blood Clots. Vonvendi may cause a blood clot in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). Some people are at higher risk of this, including people who have known risk factors for clots. Vonvendi can also cause a condition called disseminated intravascular coagulation (DIC), which can affect the body’s ability to form blood clots. Stop using Vonvendi and get emergency help if you have any of the following signs of blood clots or problems forming blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Fainting
- Trouble breathing or cough
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech or trouble understanding speech
- Pain, swelling, color change, or tenderness in your arm or leg
- Vision loss
- Bulging eyes
- Double vision
- Uncontrollable bleeding
- Bruising
- Coughing up blood
- Vomiting
- Blood in your stool (poop)
Warnings & Precautions
Who should not use Vonvendi?
Allergies to Ingredients. People who are allergic to any of the following should not use Vonvendi.
- Hamster or mouse proteins
- Von Willebrand factor, recombinant
- Vonvendi
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Vonvendi.
What should I know about Vonvendi before using it?
Vonvendi may be given by a health care provider in a hospital or clinic. If you will use Vonvendi at home, use it as prescribed, and do not try to give yourself a dose unless you have been trained by a health care provider. Read the information that comes with Vonvendi and follow the instructions carefully if you will be using it at home. Do not use Vonvendi unless it has been prescribed to you by a health care provider.
Do not share Vonvendi with other people, even if they have the same condition as you. It may harm them.
Keep Vonvendi out of the reach of children. If you will store Vonvendi in a refrigerator, take special precautions to keep it away from children who also use the refrigerator.
Vonvendi is given as an infusion into a blood vessel (IV infusion). You may receive doses of Vonvendi with factor VIII. Follow your health care provider’s instructions about how much Vonvendi to use. Tell your health care provider right away if you are still bleeding after using Vonvendi.
If you are using Vonvendi at home, use it right after mixing the dry product with the supplied sterile water. If you cannot use it right away, it can be stored at room temperature up to 77 F (25 C) for up to three hours. If you do not use Vonvendi within three hours of preparing your dose, throw it away.
Vonvendi can make you feel dizzy. Do not drive or do other activities that require alertness or coordination until you know how Vonvendi affects you.
Some people may develop antibodies (inhibitors) to Vonvendi over time, which can make the medicine not work as well. Tell your health care provider if you feel like you are not responding to Vonvendi. Your health care provider may do tests to see if you should continue Vonvendi or switch to a different medicine.
It is important to have your blood checked while using Vonvendi to make sure the medicine is working and lower the risk of side effects. Keep all appointments for blood tests while using Vonvendi.
What should I tell my health care provider before using Vonvendi?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Vonvendi is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.
- Antibodies (inhibitors) to von Willebrand factor
- Antibodies (inhibitors) to blood coagulation (clotting) factor VIII
Upcoming Travel Plans. Tell your health care provider if you are planning to travel in the near future. You may need to take Vonvendi with you so that you do not miss any doses while traveling. Missed doses of Vonvendi may increase your risk of bleeding.
Upcoming Planned Surgery. Tell your health care provider if you are planning to have surgery in the near future. Depending on your blood test results, you may need a dose of Vonvendi with or without factor VIII before surgery to lower your risk of bleeding during surgery.
Pregnancy. It is not known if or how Vonvendi could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant.
Breastfeeding. It is not known if Vonvendi passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. Your health care provider will let you know if you should use Vonvendi while breastfeeding.
How can I get more information about Vonvendi?
For more information about Vonvendi, you can visit the drugmaker’s website at www.vonvendi.com or call them at 877-825-3327.
Interactions
Does Vonvendi interact with foods or drinks?
There are no known interactions between Vonvendi and foods or drinks.
There are no known interactions between Vonvendi and alcohol, but both von Willebrand disease and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.
Does Vonvendi interact with other medicines (drug interactions)?
There are no known interactions between Vonvendi and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Vonvendi?
If you or someone else has used too much Vonvendi, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Vonvendi?
If you use Vonvendi at home and miss a dose, call your health care provider for further instructions.
If you receive Vonvendi in a hospital or clinic and miss an appointment to get your dose, call to make another appointment as soon as possible.
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