Generic Name: von Willebrand factor (recombinant)
Date of Approval: December 8, 2015
Company: Baxalta U.S. Inc.
Treatment for: Von Willebrand Disease
FDA Approves Vonvendi
Vonvendi is the first and only recombinant treatment for adults living with von Willebrand Disease (VWD).
The U.S. Food and Drug Administration (FDA) has approved Vonvendi, a recombinant von Willebrand factor indicated for on-demand treatment and control of bleeding episodes in adults (age 18 and older) diagnosed with von Willebrand disease.
This leaflet summarizes important information. Please read it carefully before using this medicine. This information does not include all of the important information about this medicine, and does not take the place of talking with your healthcare provider. If you have any questions after reading this, ask your healthcare provider.
Do not attempt to do an infusion to yourself unless you have been taught how by your healthcare provider or hemophilia center.
You must carefully follow your healthcare provider’s instructions regarding the dose and schedule so that your treatment will work best for you.
What is Vonvendi?
Vonvendi is a medicine used to replace von Willebrand factor that is missing in people with von Willebrand disease. Von Willebrand disease is an inherited bleeding disorder in which blood does not clot normally.
Vonvendi is used to treat and control bleeding episodes in adults (age 18 years and older) diagnosed with von Willebrand disease.
Who should not use Vonvendi?
You should 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 Vonvendimay not be right for you.
How should I use Vonvendi?
Vonvendi is given directly into the bloodstream. Your first dose 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 whether additional doses of recombinant factor VIII are needed.
You may receive treatment 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 do the infusions themselves or with the help of a family member.
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 receiving Vonvendi.
Use the reconstituted product (after mixing dry product with the supplied sterile water) immediately. If not, store at room temperature not to exceed 27°C (81°F) for up to three hours. Discard after three hours.
Before receiving Vonvendi
Before receiving Vonvendi, you should tell your healthcare provider if you:
- Have or have had any medical problems.
- Take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies.
- Have any allergies, including allergies to mice or hamsters.
- Are breastfeeding. It is not known if Vonvendi passes into your milk and if it can harm your baby.
- Are pregnant or planning to become pregnant. It is not known if Vonvendi can harm your unborn baby.
- 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.
Vonvendi side effects
You can have an allergic reaction to Vonvendi. Call your healthcare provider right away and stop treatment if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, lightheadedness, dizziness, nausea or fainting.
Side effects that have been reported include: nausea, tingling or burning at infusion site, chest discomfort, dizziness, hot flashes, itching, nausea, high blood pressure, muscle twitching, unusual taste, and increased heart rate.
These are not all the possible side effects. You can ask your healthcare provider for information that is written for healthcare professionals. Tell your healthcare provider about any side effects that bother you or do not go away.
What are the Vonvendi dosage strengths?
Vonvendi with Sterile Water for Injection and Mix2Vial reconstitution device comes in two different dosage strengths.
- Green Dosage strength of approximately 650 International Units (450-850 IU) (reconstituted with 5 mL of sterile water)
- Dark Red Dosage strength of approximately 1300 International Units (900-1700 IU) (reconstituted with 10 mL of sterile water)
The actual strength will be printed on the vial label and on the box. Always check the actual dosage strength printed on the label to make sure you are using the strength prescribed by your healthcare provider.
- Always check the expiration date printed on the box.
- Do not use the product after the expiration date printed on the box.
How do I store Vonvendi?
Store Vonvendi in the original box and protect from extreme exposure to light.
Store at refrigeration temperature: 2°C to 8°C (36°F to 46°F) or room temperature up to 30°C (86°F) for up to 12 months. Do not freeze.
If you choose to store Vonvendi at room temperature:
- Note the date that the product is removed from refrigeration on the box.
- Do not return the product back to the refrigerator.
- Do not use after 12 months from the date noted on the box or after the expiration date.
Store the reconstituted product (after mixing dry product with supplied sterile water) at room temperature not to exceed 27°C (81°F) for up to three hours. Discard after three hours.
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, it 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.
Medicines are sometimes prescribed for purposes other than those listed here. Do not use this medicine for a condition for which it is not prescribed. Do not share it with other people, even if they have the same symptoms that you have.