VONVENDI Now Available
VONVENDI, a recombinant von Willebrand factor, is now available from Shire (formerly Baxalta). It was approved by the U.S. Food and Drug Administration in December 2015, and is approved for use in adults 18 years of age and older who have von Willebrand disease (VWD). It is the first and only FDA approved recombinant von Willebrand factor, and is approved for on-demand (as needed) treatment for control of bleeding episodes in adults diagnosed with VWD. The safety and efficacy were evaluated in two clinical trials of 69 adult patients with VWD. No safety concerns were identified in the trials.
The first dose of VONVENDI for each bleeding episode may be administered with a recombinant factor VIII as instructed by your healthcare provider. Your healthcare provider will determine the amount of VONVENDI recommended for you depending on your weight, your type of VWD, and the severity of bleeding event you’re experiencing. VONVENDI comes in two strengths: 450-850 potency range per vial (5ml) and 900-1700 potency range per vial (10ml). The actual von Willebrand factor activity in international units is printed on the label of each vial and carton. Store VONVENDI 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:
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Note the date that the product is removed from refrigeration on the box.
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Do not return the product back to the refrigerator.
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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. VONVENDI is packaged with sterile water for Injection and one Mix2Vial mixing device.
If you are a VWD patient and would like to see if VONVENDI is right for you, please contact your Hemophilia Treatment Center. The Hemophilia of Georgia and Beacon pharmacies will need a new prescription. You may also contact me or an outreach nurse at 770-518-8272, if you have further questions.