Librela is approved as safe and effective in providing control of OA pain in dogs. Librela has been on the market in Europe for more than three years and received approval from U.S. Food & Drug Administration (FDA) for its use in the U.S. in May 2023, with millions* of dogs treated worldwide.¹ Extensive research is required to obtain these approvals, and Librela was evaluated rigorously to obtain regulatory approvals in multiple countries. The majority of dogs treated in clinical studies benefitted from a reduction in pain.^2,3 Reduction in pain can result in increased mobility and improved quality of life.^4-6

As with all veterinary medicines or vaccines, there is always a possible risk of adverse events. Therefore, it is important to work closely with your veterinarian, who knows your dog’s health history, to understand the potential risks and benefits.

At Zoetis we take potential adverse events very seriously, and our team of veterinarians and other specialists work to understand each situation brought to our attention by veterinarians, pet owners, and regulatory authorities. We submit the information from individual case reports we receive to the Food and Drug Administration Center for Veterinary Medicine and/or other relevant regulatory agencies around the world.

*doses distributed assuming 2 doses per dog

Librela is the first and only FDA-approved monthly injectable monoclonal antibody treatment to control OA pain in dogs. Dogs of all ages, sizes and breeds can experience OA pain.[7] Signs of OA pain may be easier to detect in older dogs because they often are more advanced, but the pain can start at a much younger age. Dogs even as young as 1 year old can develop the condition. The safety and effectiveness of Librela has not been evaluated in dogs less than 12 months of age.

In fact, approximately 40% of dogs show signs of OA.⁸ Yet, despite its prevalence, only 33% of dogs with OA are diagnosed and treated for the condition.⁹ It's important to identify the signs and symptoms of OA pain early to control the pain to give our dogs a better quality of life.

While limping and whimpering are obvious signs of OA pain, they’re not the only symptoms. Pet owners should also be on the lookout for the following signs of OA pain, including:

• Decreased activity;
• Lagging behind on walks;
• Slowness to rise;
• Hesitation or difficulty in jumping up or down;
• Stiffness;
• Difficulty going up or down stairs;
• Emotional changes, such as becoming more withdrawn or less happy and excited, or even showing signs of aggression or irritated behavior.

Pay attention to your dog’s physical and emotional behaviors and share any changes with your veterinarian to help determine if these are signs of OA pain and how they can be managed. Consider recording videos of your dog too, to help your veterinarian understand the changes you are observing. Waiting until the condition becomes severe can increase the amount of pain and decrease mobility, negatively impacting a dog’s physical and emotional well-being.¹⁰ While OA cannot be cured, the control of pain can be provided for the chronic pain associated with OA.

As with all medicines, there are potential adverse events. Pet owners should always consult their veterinarian for an accurate diagnosis and discuss the benefits and risks before embarking on any treatment. With over 14 million doses distributed over three years, Librela is proven to be a safe and effective means to control OA pain in dogs.¹⁴ Overall, when we look at the adverse events globally, no single category of event is classified as more than rare.*

* Rare is defined as greater than or equal to 1 and less than 10 dogs per 10,000 treated.¹⁵

The most common side effects that occurred in a clinical study were urinary tract infections, bacterial skin infections and dermatitis.¹¹ There are potential adverse events associated with all veterinary products, so it’s important to work closely with your veterinarian, who knows your dog’s health history, to understand the potential risks and benefits.

Full Prescribing Information for Librela can be found here: https://www.zoetisus.com/content/pages/Products/Dogs/Librela/Resources/documents/Librela-prescribing-information.pdf

Zoetis works closely with veterinarians to not only provide education across all of our brands and support their staff, but to also listen to feedback, questions and concerns. Recent feedback from 100 U.S. veterinarians on overall satisfaction with Librela is high, with 78% being Extremely Satisfied or Very Satisfied.¹²

In a survey of 580 veterinarians in Europe, Librela rated higher than branded NSAIDS on the top four product attributes that veterinarians rank as most important in that category including: improves quality of life, improves patient mobility, effectively reduces pain and has few side effects.¹³ For additional context, please see this article featuring leading voices in the industry.

Each country has different regulatory guidelines and expectations for labeling. We work with the regulatory agency in each country to get our products reviewed and approved according to each country’s guidelines.

At Zoetis, we take suspected adverse events very seriously, for all of our products including Librela. Our team of veterinary experts work alongside both pet owners and their attending veterinarians to understand each pet’s unique situation when brought to our attention. We know that all pets have different lifestyles, health conditions, genetics etc. and understanding all of these elements is important to evaluating a pet’s full health profile.

Zoetis also has systems in place to continuously monitor the volume and trends of adverse event reporting related to all of our veterinary medicines, including Librela. We are required to share these reports of aggregated case data to regulatory agencies around the world, and if a new safety signal emerges, we partner with regulatory authorities on appropriate actions which could include amendment of our label as necessary to better inform veterinarians and pet owners of potential risks or safety concerns to mitigate risks to the pet.

We encourage all pet owners who believe their pet may have had an adverse reaction to any medication, to contact their pet’s veterinarian first. Pet owners also need to contact Zoetis, and when they do, we document the conversation and make every effort to include the attending veterinarian in the conversation. This helps us fully understand each case and report a potential adverse effect to the appropriate regulatory body. We always encourage pet owners to also speak with their veterinarian for further consultation and advice after speaking with the Zoetis team.

Librela (bedinvetmab injection) is approved in many countries around the world, including in the U.S., EU (EEA), Canada, Brazil, Australia, UK and Japan. More information about Librela can be found here: https://www.zoetispetcare.com/products/librela