Labeling Update Alert: Librela® (bedinvetmab injection), NADA 141-562

Overview

Librela® (bedinvetmab injection), the first monoclonal antibody approved in the U.S. to control osteoarthritis pain in dogs, received important label updates on February 18, 2025, under NADA 141-562. These changes reflect data gathered from real-world post-approval use since its U.S. launch in October 2023.

Veterinary pharmacists are critical in communicating these updates, monitoring for adverse events, and ensuring informed use.

Key Label Changes

  1. Dosage and Administration
    • Veterinarians are now advised to provide the Client Information Sheet to pet owners.
    • Prior to administration, clinicians should discuss the potential for adverse events with the owner. 1
  1. Post-Approval Experience
    • Newly added section outlines reported adverse reactions:
      • Ataxia
      • Seizures
      • Other neurologic signs (e.g., paresis, recumbency, urinary incontinence)
      • Polyuria, polydipsia
      • Death, including euthanasia 2
  1. Information for Dog Owners
    • The label now includes guidance to help veterinarians educate pet owners on benefits, risks, and what to monitor post-treatment. 3
  1. Client Information Sheet
    • A new, easy-to-understand document has been developed for pet owners. This sheet outlines Librela’s use, benefits, potential risks, and when to seek veterinary attention.4

Global Safety Profile

  • Librela has been used in over 25 million doses worldwide.
  • Adverse events have been classified as rare (<10 cases per 10,000 dogs treated) by the European Medicines Agency.5

Zoetis continues to collaborate with the FDA and support veterinary professionals with educational resources and pharmacovigilance programs.6

Key Takeaways for Veterinary Pharmacists

  • Distribute the Client Information Sheet at every administration.
  • Promote informed discussions about potential adverse effects with clients and clinicians.
  • Encourage timely adverse event reporting to both Zoetis and the FDA.
  • Stay up-to-date using Zoetis-provided CE webinars and medical affairs support.

References

Footnotes

  1. Zoetis Inc. (2025, Feb 4). U.S. Label Update for Librela (bedinvetmab injection). https://investor.zoetis.com ↩
  2. U.S. FDA. (2025). Dear Veterinarian Letter – Adverse Events with Librela. https://www.fda.gov ↩
  3. Animal Health Digest. (2025). Librela Labeling Update Summary. https://animalhealthdigest.com ↩
  4. Zoetis. (2025). Client Information Sheet – Librela®. Distributed via Zoetis representatives and vet portals. https://www.zoetisus.com/content/_assets/docs/vmips/package-inserts/librela-client-information-sheet.pdf
  5. European Medicines Agency. (2024). Pharmacovigilance Summary for Librela (bedinvetmab).
    https://www.ema.europa.eu/en/medicines/veterinary/EPAR/librela  ↩
  6. Zoetis Medical Affairs. (2025). Veterinary Education Resources for Librela. https://www.zoetisus.com/products/dogs/librela/  ↩