MEDICAL ADVISORY
Released: February 24, 2025, 7:56 PM EST
Medical Advisory: ALTUVIIIO LOT #EY0330
OVERVIEW
Sanofi is conducting a voluntary recall of ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN] lot #EY0330 due to erroneous labeling of product dose potency. The 2000 IU nominal vial potency was incorrectly labeled with an actual potency of 2132 IU/mg on finished products and cartons, instead of the correct value of 1811 IU/vial. The nominal value of 2000 IU/vial remains accurate, and the actual potency is still within FDA-approved manufacturing specifications.
PRESCRIBER ACTION REQUIRED
The dose of ALTUVIIIO lot #EY0330 is consistent with the recommended dosing in the USPI and is not expected to have a clinical impact on patients following prophylactic regimens, as FVIII activity levels should remain in the protective range to prevent spontaneous bleeding.
Please take the following actions:
- Work with your pharmacy and distributors to notify any patients who received this lot
- Instruct patients to discontinue use and return all products from this lot
- Note that pharmacies have already been notified about the recall
- If patients require treatment before receiving replacement products, calculate doses based on vial potency of 1811 IU/vial and/or per clinical judgment.
BACKGROUND
Therapeutic Indication ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived Factor VIII concentrate indicated for adults and children with hemophilia A (congenital factor VIII deficiency) for:
- Routine prophylaxis to reduce bleeding episode frequency
- On-demand treatment & control of bleeding episodes
- Perioperative bleeding management
Cause for Recall and Mitigating Actions: Sanofi voluntarily recalled this batch to remove incorrectly labeled units from the market. Out of an abundance of caution, distributed vials are being recalled and will be replaced.
Supportive Evidence for Mitigation Measures The dose of ALTUVIIIO lot #EY0330 aligns with USPI-recommended dosing and is not expected to impact patients on prophylactic regimens, as FVIII activity levels should remain in the protective range. For bleeding situations and perioperative management, patients should still be protected. FVIII levels are typically monitored during perioperative periods to determine if additional doses are needed to maintain hemostasis.
PATIENT MONITORING
No specific measures are required. Please refer to the Prescribing Information for details regarding ALTUVIIIO treatment.
For further information, contact your local Sanofi Medical Information Hotline at 1-800-633-1610, option 1.
PHYSICIANS: Please distribute this information to all providers in your area who treat patients with hemophilia and bleeding disorders.
CHAPTERS: Please distribute this information to your membership.
Please sign up for the Patient Notification System (PNS) to receive direct notifications about the latest recalls or withdrawals of recombinant and plasma products. The system is confidential, time-sensitive, and administered by an independent third-party organization free of charge. To enroll in the PNS, call (888) UPDATE-U or visit http://www.patientnotificationsystem.org.
Download the Full PDF Announcement
