Vonvendi
Vonvendi is an intravenous (IV) infusion used to treat von Willebrand disease (VWD), a condition where the blood doesn't clot properly. It’s FDA approved for children and adults to treat and control bleeding episodes and to help manage bleeding during surgery. Adults can also use it regularly to help prevent bleeding episodes. You’ll use the medication as needed for bleeding or surgery, or twice a week to prevent bleeds. Common side effects include headache, nausea, and itching.
What is Vonvendi?
What is Vonvendi used for?
- Treatment and control of bleeding episodes in adults and children with von Willebrand disease (VWD)
- Management of bleeding for surgery in adults and children with VWD
- Routine prevention of bleeding episodes in adults with VWD
How Vonvendi works
Vonvendi is a von Willebrand factor (VWF) replacement. VWF is a natural protein that helps platelets stick to injured blood vessels. It also carries and protects factor VIII, another clotting protein.
By replacing low or missing VWF in people with von Willebrand disease, Vonvendi helps your blood form stable clots and reduces bleeding.
Drug facts
| Common Brands | Vonvendi |
|---|---|
| Drug Class | Coagulation factor replacement |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Vonvendi
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (14%)
- Vomiting (7%)
- Nausea (5%)
- Dizziness (3%)
- Itching (2%)
Less Common Side Effects
- Hot flush
- High blood pressure
- Fast heartbeat
- Numbness at infusion site
- Abnormal taste
- Tremor
Vonvendi serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reaction: hives, rash, swelling of face/lips/tongue, tight chest, wheezing, trouble breathing, low blood pressure, feeling faint
- Blood clots: sudden leg swelling or pain, chest pain, shortness of breath, coughing up blood, sudden weakness on one side, trouble speaking, severe headache
- Infusion reactions: chest discomfort, fast heartbeat, flushing, itching, shortness of breath, restlessness, blurred vision
The following Vonvendi side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Vonvendi
Pros
- Approved for both adults and children
- Replaces missing clotting protein directly
- A lab-made product, not made from human blood like other clotting treatments
Cons
- Requires IV infusion into a vein
- Risk of allergic reactions and infusion reactions
- Rare risk of blood clots
Pharmacist tips for Vonvendi
- Your care team might train you to prepare and give Vonvendi infusions at home. Follow the instructions carefully to learn how to give the injection. Contact your care team if you have questions.
- Keep a written bleed plan with Vonvendi. Share it with your emergency contacts and your care team. This helps you treat bleeds quickly and safely.
- Depending on your lab results, your prescriber might add recombinant factor VIII with your first Vonvendi dose to help raise levels quickly. This can improve bleeding control.
- You’ll need blood tests while using Vonvendi to check your levels. This helps make sure you reach targets and to avoid factor VIII getting too high, which can raise clot risk.
- Watch for allergic or infusion reactions with Vonvendi. Stop the infusion and get help if you have hives, swelling, tight chest, wheezing, or feel faint.
- Vonvendi rarely causes blood clots, but they can be serious. Learn clot warning signs while using Vonvendi. Call for urgent help if you have sudden leg swelling/pain, chest pain, coughing blood, or stroke‑like symptoms.
- If you miss a dose of Vonvendi, contact your care team. They’ll tell you when to take the next dose and how to protect yourself from bleeds in the meantime.
- Some pain relievers might not be safe with Vonvendi. Ask your care team before taking medications like ibuprofen or naproxen since they can raise your bleeding risk.
- If you're planning to travel, make a plan with your prescriber so you don't run out of Vonvendi.
- Storage: Keep Vonvendi vials in the original box in the refrigerator or at room temperature. Protect them from light and don’t freeze them.
- Use Vonvendi within 3 hours after mixing, then throw away any leftover. This keeps the medication stable.
How to prepare and use Vonvendi:
- Wash your hands and set up a clean area. Bring the vial and sterile water to room temperature.
- Use the supplied Mix2Vial to add the sterile water to the vial, then gently swirl until it dissolves. Don’t shake.
- Draw the clear solution into a plastic syringe and check for particles. Don’t use it if it looks cloudy or has particles.
- Infuse the mixture into a vein as directed within 3 hours of mixing, up to 4 mL per minute. If your plan includes recombinant factor VIII, infuse it within 10 minutes after Vonvendi.
- Throw away used needles and supplies safely using a sharps container to prevent injuries.
Risks and warnings for Vonvendi
Vonvendi can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Blood clots
- Risk factors: Known risk for blood clots | Taking Vonvendi with recombinant factor VIII often | High factor VIII levels
Vonvendi can cause blood clots, but this isn't common. These clots can happen in different parts of your body and might lead to serious problems like a heart attack, stroke, or a lung clot. Your risk is higher if you already have risk factors, if your factor VIII levels stay high, or if you use recombinant factor VIII with Vonvendi.
Your care team will watch for symptoms like leg pain or swelling, chest pain, shortness of breath, coughing up blood, severe headache, or trouble speaking. They will also check your blood levels and adjust your dose if needed. Get medical help right away if you have sudden symptoms of a blood clot.
Serious allergic reactions and infusion-related reactions
- Risk factors: Mouse or hamster allergy
Allergic and infusion reactions can happen during or after a Vonvendi infusion. These can include hives, swelling, chest tightness, low blood pressure, trouble breathing, nausea, or feeling very tired. In rare cases, a severe reaction like anaphylaxis can happen. Stop the infusion and get help right away if you notice these symptoms and let your care team know. Vonvendi contains small amounts of non-human proteins, which could trigger these reactions in some people.
Development of antibodies against VWF and/or factor VIII
Your immune system can rarely make antibodies (called inhibitors) against VWF or factor VIII. This can make Vonvendi work less well. Signs include bleeding that doesn’t improve as expected or lab levels that don’t rise as planned.
Your prescriber might order special tests to check for inhibitors and could refer you to a bleeding specialist. If inhibitors are found, you might need different treatment, and allergic reactions can sometimes happen at the same time.
Vonvendi dosage
Typical dosage for Vonvendi
-
Treatment and control of bleeds (adults and children)
- Minor bleeds: The typical starting dose is 40 IU/kg to 50 IU/kg of body weight given through the veins (IV). Additional doses of 40 IU/kg to 50 IU/kg are given every 8 to 24 hours until bleeding stops.
- Major bleeds: The typical dose is 50 IU/kg to 80 IU/kg of body weight given IV. Additional doses of 40 IU/kg to 60 IU/kg are given every 8 to 24 hours for about 2 to 3 days or as needed.
-
Management of bleeding for surgery (adults and children): Your prescriber will choose your starting dose based on your body weight, how severe your bleeding is, where it’s happening, and the target VWF level.
- You might receive one dose given IV 12 to 24 hours before your surgery, then another 1 hour before surgery. Your care team will check your VWF and factor VIII levels and give additional doses every 12 to 24 hours to keep levels in a safe range.
-
Routine treatment to prevent bleeds
- Adults: The typical dose is 40 IU/kg to 60 IU/kg of body weight given IV twice a week.
Vonvendi contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Vonvendi will not be safe for you to take.
- Life‑threatening allergic reaction to Vonvendi or its components (tri‑sodium citrate‑dihydrate, glycine, mannitol, trehalose‑dihydrate, polysorbate 80)
- Allergy to mice or hamsters
