The Australian Pesticides and Veterinary Medicines Authority (APVMA) continues to closely monitor reports of adverse experiences associated with Beransa (also known as Bedinvetmab, or Librela) both in Australia and internationally.
This product is available by veterinarian prescription only, and veterinarians are best placed to assess the individual needs of each dog, balancing potential risks and benefits of the product.
Beransa is a monoclonal antibody drug used for the alleviation of pain associated with osteoarthritis in dogs. Current information indicates that side effects are rare when this product is used in accordance with label directions.
Last year, the product holder updated the label to include further information on side effects, and we are currently assessing a new label variation application, submitted in January 2025, to make further updates to the side effects section.
About
The APVMA registered Beransa in September 2022. This product must be administered by a registered veterinarian or under their direct supervision.
The APVMA rigorously assessed available evidence during the initial registration process and is satisfied that the product meets the safety, efficacy, trade, and labelling criteria when used as directed.
The APVMA assesses agvet chemical products on the basis that the products will be used in line with the approved instructions. It is important to always follow label instructions to ensure agvet chemical products are applied safely and effectively.
This product must not be used for:
- Dogs under 12 months old
- Dogs with hypersensitivity to the active ingredient
- Dogs intended for breeding
- Pregnant or lactating dogs
Side effects
The APVMA updated the list of side effects on the Beransa’s label in August 2024 in response to an application from the registrant to reflect the Australian experience and to align with international jurisdictions. This update included the addition of rarely identified side effects.
Side effects listed on Beransa labels include:
- Mild reactions at the injection site (for example, swelling and heat)
- Polydipsia and polyuria
- Hypersensitivity-type reactions (anaphylaxis, facial swelling, pruritus)
- Immune-mediated haemolytic anaemia and immune-mediated thrombocytopenia
The APVMA continues to closely monitor Beransa products, and other registered agvet chemicals in the Australian marketplace, to identify side effects that may not have been detected in the initial registration process.
Reporting an adverse experience
The APVMA’s Adverse Experience Reporting Program (AERP) assesses reports from the public of adverse experiences associated with the use of registered agvet chemical products. This program helps the APVMA to record and assess unintended or unexpected adverse events, which may not have been detected when a product was initially registered.
The APVMA encourages anyone who believes they have experienced problems with an agvet chemical product to submit a report to the AERP via the online reporting form.
The APVMA may take appropriate regulatory action in response to these reports to ensure products continue to meet the strict safety, and efficacy standards required by Australian law. The APVMA will take immediate action if we determine it is necessary to prevent imminent serious risk to the Australian community.