The Australian Pesticides and Veterinary Medicines Authority (APVMA) has updated the labels for Beransa Solution for Injection for Dogs (also known as Bedinvetmab, or ‘Librela’ overseas).
This update includes rare, and very rare side effects identified through adverse experience reporting.
The updated APVMA-approved Beransa labels now include:
- Rare side effects:
- Urinary incontinence
- Lethargy
- Gastrointestinal signs (vomiting, diarrhoea)
- Anorexia (often transient)
- Ataxia
- Very rare side effects:
- Behavioural changes
- Musculoskeletal disorders (e.g. weakness)
- Neurological events (e.g. seizures)
The full updated list of side effects on APVMA-approved Beransa labels are listed in Table 1 below.
Side effects
The APVMA follows international best practice for the categorisation of side effects based on how likely they are to occur. The 3 categories applicable to Beransa products are:
- Uncommon – 1 to 10 cases per 1000 animals treated
- Rare - less than 10 cases per 10,000 animals treated
- Very rare – less than 1 case per 10,000 animals treated
Table 1: Side effects listed on Beransa labels
| Uncommon |
|
|---|---|
| Rare |
|
| Very Rare |
|
- Side effects listed on the label before August 2025 are marked with an *
- In August 2024 APVMA released a previous update to Beransa labels
The updated labels can be viewed in full using the APVMA’s PubCRIS database.
This decision to update the labels followed detailed scientific analysis of adverse experiences reported by Australian veterinarians and members of the public, and evidence provided by the registration holder to the APVMA. The APVMA reached similar conclusions to comparable international regulators regarding adverse events related to this product.
This change will provide transparency and updated advice for veterinarians and pet owners, regarding potential side effects that may be experienced.
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.
About
Beransa is a monoclonal antibody drug used for the alleviation of pain associated with osteoarthritis in dogs. The APVMA registered Beransa in September 2022. 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.
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 their approved instructions. It is important to always follow label instructions to ensure agvet chemical products are applied safely and effectively.
Veterinarians and pet owners should be aware of potential side effects listed on Beransa labels, including the additional side effects referenced in this update on 8 August 2025.
Current Australian post-market information indicates that side effects are rare (or very rare) when this product is used in accordance with label directions.
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
Reporting an adverse experience
The APVMA’s Adverse Experience Reporting Program (AERP) assesses reports 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 it determines it is necessary to prevent imminent serious risk to the Australian community.