Vonvendi
Pronunciation: von-ven-di
Generic name: von Willebrand factor (recombinant)
Dosage form: lyophilized powder in a single-dose vial (650 IU, 1300 IU)
Drug class: Miscellaneous coagulation modifiers
What is Vonvendi? von Willebrand Disease Medication
Vonvendi is a recombinant medicine used to treat and control bleeding episodes or prevent excessive bleeding during and after surgery in adults and children diagnosed with von Willebrand's disease. It is also used in adults to reduce the number of bleeding episodes when used regularly (prophylaxis). It is given by injection and the dosage depends on the severity of the bleeding episode, the person's weight, and/or what it is being used for (treatment, perioperatively, or prevention).
Vonvendi (von Willebrand factor [recombinant]) works by replacing low levels of von Willebrand factor that are not properly functioning in people with von Willebrand disease. Von Willebrand disease is an inherited bleeding disorder in which blood does not clot normally.
Warnings
Absolute Contraindications
Do not use Vonvendi if you:
-
are allergic to any ingredients in Vonvendi
-
are allergic to mice or hamsters.
Tell your healthcare provider if you are pregnant or breastfeeding because Vonvendi may not be right for you.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Vonvendi Side Effects
Common Side Effects:
- Headache
- Nausea or vomiting
- Tingling or burning at the infusion site
- Chest discomfort, high blood pressure, or an increased heart rate
- Dizziness
- Hot flashes
- Itching
- Muscle twitching
- Unusual taste
- Blood clots.
Serious side effects
Vonvendi may cause an allergic reaction. Get emergency medical help if you have signs of an allergic reaction to Vonvendi, such as hives, itching, tightness in your throat or chest, difficulty breathing, or swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
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sudden numbness or weakness (especially on one side of the body);
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chest pain or pressure, sudden cough, wheezing, rapid breathing, coughing up blood;
-
pain, swelling, warmth, or redness in one or both legs;
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nausea; or
-
a light-headed feeling, like you might pass out.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Related/similar drugs
Before taking this medicine
Tell your healthcare provider if you:
- Have or have had any medical problems
- Have been told that you have inhibitors to von Willebrand factor (because VONVENDI may not
work for you) - Have been told that you have inhibitors to blood coagulation factor VIII.
- Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies
- Are pregnant, or planning to become pregnant
- Are breastfeeding.
Pregnancy and Breastfeeding Considerations
Pregnancy: It is not known if Vonvendi can harm your unborn baby.
Breastfeeding: It is not known if Vonvendi passes into your milk and if it can harm your baby.
How Should I Use Vonvendi?
Vonvendi is given directly into the bloodstream (intravenously).
- You may infuse Vonvendi at a hemophilia treatment center, at your healthcare provider’s office, or in your home.
- You should be trained on how to do infusions by your healthcare provider or hemophilia treatment center.
- Many people with von Willebrand disease learn to infuse Vonvendi by themselves or with the help of a family member.
- Use the reconstituted product (after mixing dry product with the supplied sterile water) immediately.
If not, store at room temperature not to exceed 25°C (77°F) for up to 3 hours. Discard after 3 hours.
On-Demand Treatment and Control of Bleeding Episodes
Your first dose of Vonvendi for each bleeding episode may be administered with a recombinant factor VIII (factor VIII not produced from plasma) as instructed by your healthcare provider.
- Your healthcare provider will instruct you on whether additional doses of Vonvendi with or without recombinant factor VIII are needed.
- Your healthcare provider will tell you how much Vonvendi to use based on your weight, the severity of your von Willebrand disease, and where you are bleeding.
- Call your healthcare provider right away if your bleeding does not stop after taking Vonvendi.
Perioperative Management of Bleeding
For elective surgical procedures, Vonvendi is given 12-24 hours pre-surgery to raise endogenous factor VIII levels.
- Your healthcare provider will assess your FVIII:C levels within 3 hours pre-surgery.
- If levels are at or above the minimum target levels, they will administer a dose of Vonvendi alone within 1 hour before the procedure.
- If FVIII:C levels are below the recommended target levels, they will administer recombinant factor VIII in addition to Vonvendi to raise VWF:RCo and FVIII:C.
For emergency surgery:
- Your healthcare provider will assess baseline VWF:RCo and FVIII:C levels within 3 hours prior to surgery or use a weight-based dosing calculation if these are not available.
- Vonvendi will be adminsitered 1 hour before surgery with or without recombinant factor VIII and the dose adjusted to raise VWF:RCo and FVIII:C to an adequate level.
- Your healthcare provider will continue to monitor VWF:RCo and FVIII:C plasma levels after the surgical procedure.
Routine Prophylaxis in Adults to Reduce the Frequency of Bleeding Episodes
- The initial dosage of Vonvendi is 40 to 60 IU/kg body weight to be administered twice weekly.
- Treat breakthrough bleeding as per the dosing guidelines.
Vonvendi Dosage Strengths
Vonvendi comes in two strengths, each with sterile water and the Mix2Vial device:
- Green vial: 650 IU (450–850 IU range) - reconstitute with 5 mL sterile water
- Dark Red vial: 1300 IU (900–1700 IU range) - reconstitute with 10 mL sterile water
Important reminders:
- Check the actual strength on the vial label and box - use only the strength prescribed
- Check the expiration date on the box
- Do not use after the expiration date.
What happens if I miss a dose?
Since Vonvendi is used when needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using Vonvendi.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What other drugs will affect Vonvendi?
Other drugs may interact with von Willebrand factor, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
What else should I know about Vonvendi and von Willebrand Disease?
Your body can form inhibitors to von Willebrand factor or factor VIII. An inhibitor is part of the body’s normal defense system. If you form inhibitors, they may stop Vonvendi or FVIII from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to von Willebrand factor or factor VIII.
How do I store Vonvendi?
Store refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature not to exceed 30°C (86°F).
- Do not freeze.
- Store in the original box and protect from extreme exposure to light.
- Do not use beyond the expiration date.
- Do not use the product if the solution is not clear or if it contains particles after you draw it into the syringe.
- Use the reconstituted product (after mixing dry product with supplied sterile water) immediately or within 3 hours of reconstitution.
- Store the reconstituted product at room temperature not to exceed 25°C (77°F) for up to 3 hours.
- Discard any unused reconstituted product after 3 hours.
Manufacturer
Vonvendi is manufactured by takeda Pharmaceuticals USA Inc., Cambridge, MA 02142.
References
More about Vonvendi (von willebrand factor)
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- FDA approval history
- Drug class: miscellaneous coagulation modifiers
- Breastfeeding
- En español
Professional resources
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.