Takeda Issues US Recall of Two Lots of VONVENDI

The affected lots were tested prior to release and passed all testing requirements for sterility, quality, safety and potency.

There is no impact on supply or to patients as recalled product will be replaced.

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.

• 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

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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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