The Australian Pesticides and Veterinary Medicines Authority (APVMA) has approved updated labels for Beransa Solution for Injection for Dogs to include additional safety information. Beransa contains the active ingredient bedinvetmab and is known as ‘Librela’ overseas.
The updated labels include additional very rare side effects and new precautions, following reports of adverse experiences associated with Beransa’s use.
What has changed
The label changes are outlined below.
New ‘Precautions’ statements
Use with caution for dogs that have:
- new or increased joint swelling and/or joint pain following Beransa treatment
- immune-mediated haemolytic anaemia, immune-mediated thrombocytopenia or immune-mediated polyarthritis, as the use of Beransa in dogs with these conditions has not been evaluated
- pre-existing convulsion (seizure) disorders, as the use of Beransa in dogs with this condition has not been evaluated.
Very rare side effects
- Paralysis
- Paresis
- Joint swelling
- Joint pain
- Bone and joint disorder
- Soft tissue ossification
Table 1 below lists all side effects included on the updated APVMA-approved Beransa labels. Newly added side effects are marked with an asterisk (*).
Understanding the side effects
The APVMA uses internationally recognised categories to describe how often side effects may occur. The 3 categories used for Beransa are:
- Uncommon – 1 to 10 cases per 1000 animals treated (doses).
- Rare – less than 10 cases per 10,000 animals treated (doses).
- Very rare – less than 1 case per 10,000 animals treated (doses).
| Uncommon |
|
|---|---|
| Rare |
|
| Very rare |
|
* New side effects listed on the label from November 2026
The full updated labels are available on the APVMA’s PubCRIS database.
Why the labels were updated
The APVMA approved these changes after a detailed scientific assessment of reports from Australian veterinarians and members of the public, alongside evidence provided by the company that holds Beransa’s registration. The APVMA reached similar conclusions to comparable overseas regulators about adverse events associated with Beransa.
The APVMA continues to closely monitor Beransa and other registered agricultural and veterinary chemical products used in Australia. This helps identify side effects that may not have been detected when products were first registered.
About Beransa
Beransa is a monoclonal antibody medicine used to relieve pain associated with osteoarthritis in dogs. The APVMA registered it in September 2022. It is available only with a veterinarian’s prescription. Veterinarians are best placed to assess each dog’s needs and weigh the potential benefits and risks of treatment.
The APVMA rigorously assessed the available evidence before registering Beransa and is satisfied that it meets the required safety, effectiveness, trade and labelling criteria when used as directed.
Information for veterinarians and pet owners
The APVMA assesses agricultural and veterinary chemical products on the basis that they will be used according to their approved instructions. Always following label instructions is important for their safe and effective use.
Veterinarians and pet owners should familiarise themselves with the potential side effects listed on Beransa’s labels, including those added in this update on 12 November 2026.
The approved labels list uncommon, rare and very rare side effects, as shown in Table 1.
Beransa must not be used for dogs:
- under 12 months old
- with hypersensitivity to the active ingredient
- intended for breeding
- that are pregnant or lactating.
Reporting a suspected side effect or other problem
The APVMA’s Adverse Experience Reporting Program (AERP) records and assesses reports of problems associated with registered agricultural and veterinary chemical products. These reports help identify unintended or unexpected effects that may not have been detected when a product was first registered.
Anyone who suspects a side effect or other problem associated with an agricultural or veterinary chemical product is encouraged to report it to the APVMA using the online reporting form.
The APVMA may take regulatory action in response to these reports to ensure products continue to meet the strict safety and effectiveness standards required by Australian law. It will take immediate action if it determines this is necessary to prevent an imminent serious risk to the Australian community.