Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the company has issued a US only voluntary, limited recall for VONVENDI® [von Willebrand factor (recombinant)] (1,300 IU) for lots numbered TVA19005AA and TVA19005AB. Although both lots met all acceptance criteria, Takeda is issuing a voluntary recall out of an abundance of caution. Takeda believes that despite this voluntary recall that there is no impact to the sterility, quality, safety and potency of the two lots of VONVENDI in scope of the recall.
Product from these lots will be recalled at the pharmacy level. No patient action is required. In addition, this recall will not impact availability of VONVENDI for patients, as recalled product will be replaced.
Takeda is communicating with healthcare professionals, patient advocacy organizations, specialty pharmacies and other customers in the US regarding the actions required as a result of the recall. This recall is being conducted in full transparency with the US Food and Drug Administration (FDA), and is limited to these two lots of VONVENDI, from which 3,425 vials have been distributed in the US only. No other Takeda products are affected, and the company has confirmed that all VONVENDI lots produced before and after the investigation of these lots are not impacted by the recall. Additionally, there is no impact to product availability, as sufficient supply is available to meet patient needs.
VONVENDI is indicated for adults (age 18 years and older) diagnosed with von Willebrand disease to treat and control bleeding episodes and prevent excessive bleeding during and after surgery.
Healthcare providers with medical-related questions, information about an Adverse Event or other questions about the VONVENDI recall should contact Takeda Medical Information at 1-800-828-2088 and select option 2; patients with questions about the VONVENDI recall should contact their specialty pharmacy or prescribing physician. For full prescribing information, including warnings and precautions, please visit http://www.shirecontent.com/PI/PDFs/VONVENDI_USA_ENG.pdf.
Adverse reactions or quality problems experienced with the use of this product may be reported to the US FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
What is VONVENDI?
VONVENDI is used in adults (age 18 years and older) diagnosed with von Willebrand disease to:
Detailed Important Risk Information
Who should not use VONVENDI?
You should not use VONVENDI if you:
Tell your healthcare provider if you are pregnant or breastfeeding because VONVENDI may not be right for you.
How should I use VONVENDI?
Your 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 instruct you whether additional doses of VONVENDI with or without recombinant factor VIII are needed.
What should I tell my healthcare provider before I use VONVENDI?
You should tell your healthcare provider if you:
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 factor VIII 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.
What are the possible side effects of VONVENDI?
Tell your healthcare provider about any side effects that bother you or do not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see VONVENDI full Prescribing Information:
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About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com.