Better Health, Brighter Future
Update on US Recall of Two Lots of VONVENDI® [von Willebrand factor (recombinant)]
March 6, 2020
- Takeda has been in contact with all pharmacies, distributors and hemophilia treatment centers that received the affected lots, as well as physicians and relevant organizations, regarding required actions around the recall
- Takeda is reaching out to reassure patients that affected lots passed all testing and quality requirements.
Lexington, Mass. and Osaka, Japan, March 6, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) is providing an update on the US-only voluntary, limited recall for VONVENDI® [von Willebrand factor (recombinant)] (1,300 IU) for lots numbered TVA19005AA and TVA19005AB that was announced on February 25, 2020.
Over the course of the last several days, Takeda has contacted all pharmacies, distributors and hemophilia treatment centers who received affected vials and has maintained close contact with physicians and organizations representing the bleeding disorders community to further contextualize the reason for recall and the actions required as a result. Takeda is also informing patients through our website and the Plasma Protein Therapeutics Association (PPTA) Patient Safety Notification system. Although there is no requirement for patients to return medicine from these lots because it is safe to use, Takeda is working to inform patients that we will replace any medicine they have from these lots if requested.
Takeda has reassured the community that the voluntary pharmacy-level recall of VONVENDI lots TVA19005AA and TVA19005AB is for regulatory and compliance reasons only. Before any medicine is distributed to patients, Takeda tests it thoroughly and performs comprehensive quality assurance checks. These involve testing for sterility, appearance, potency and other aspects to ensure the medicine is effective and safe. The two lots of VONVENDI were produced using our standard process without any issues occurring and passed all testing and quality assurance requirements.
Takeda has rigorous procedures in place that ensure we are checking every step of our manufacturing methods. As part of routine activities at our manufacturing sites, we periodically test our processes. During a test in August, we observed that one step did not proceed as expected. We assessed this situation thoroughly and determined that there was no impact to these two VONVENDI lots, meaning they were manufactured properly. Takeda maintains a close working relationship with the FDA, and as part of our process we informed them of this observation.
During a routine FDA inspection of the VONVENDI manufacturing site in January, the FDA inspector reviewed the test of our process that was performed in August. The inspector provided feedback on how we could improve our approach. Consequently, Takeda decided to pull back any VONVENDI vials that had not been distributed from these two lots.
Takeda’s safety and quality testing demonstrated that the VONVENDI batches in question were safe for patient use, and therefore didn’t meet the criteria for a patient-level recall, which would be used if the product could pose a risk to patients. As a result, Takeda decided to voluntarily pull back these two lots from pharmacies only. This decision was made for regulatory and compliance reasons, not for safety reasons. Takeda shared the decision to pull the lots back with the FDA, and after confirming communications, announced this action on February 25, 2020.
Takeda believes that despite this voluntary recall, the two lots of VONVENDI were produced using Takeda’s standard process without any issues occurring and passed all testing and quality assurance requirements. 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. Takeda has sufficient inventory of VONVENDI from other lots in order to replace recalled product.
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.
We understand the concerns of the bleeding disorders community and apologize for any alarm and confusion that this situation may have caused. We understand how important these medicines are to patients’ health, and we are committed to providing products of the highest standards.
Although there is no requirement for patients to return medicine because it is safe to use, we’ve heard from you and from patients that they would like the opportunity to return medicine from these lots and have it replaced with medicine from different lots. Patients who have product from the identified lots may contact Takeda’s Hematology Support Center at 888-229-8379, Monday - Friday from 8:30 a.m. to 8:00 p.m. Eastern Time. To receive replacement product, the return of current vials is not mandatory, and the HSC will help to provide patients with replacement vials. If a patient would like to return product, we will send a pre-paid mailer to expedite that process.
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.
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.
- Complete and submit the report online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htm, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
- Call 1-800-332-1088 to report by phone
How to Identify Your VONVENDI Lot Number
The lot number can be found in these locations:
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On top of the MIX2VIAL™ device pack |
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On the VONVENDI vial label |
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On the VONVENDI device package |
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VONVENDI® [von Willebrand factor (recombinant)] Important Information
What is VONVENDI?
VONVENDI is used in adults (age 18 years and older) diagnosed with von Willebrand disease to:
- treat and control bleeding episodes
- prevent excessive bleeding during and after surgery
Detailed Important Risk Information
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 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:
- 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.
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?
- 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 with VONVENDI include: nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, hot flashes, itching, high blood pressure, muscle twitching, unusual taste, blood clots and increased heart rate.
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:
http://www.shirecontent.com/PI/PDFs/VONVENDI_USA_ENG.pdf
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Contacts
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Media in Japan
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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.