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The First and Only Monthly Injectable Anti-NGF Monoclonal Antibody Therapy for the Control of Canine Osteoarthritis (OA) Pain

This site is intended for US Animal Healthcare Professionals. Visit Pet Owner Site.

LIBRELA OVERVIEW

Librela Is the First and Only Monthly Injectable Monoclonal Antibody Therapy for Dogs With OA Pain
  • Approved as safe and effective and provides long-term canine OA pain control1-3
  • A monthly subcutaneous injection, administered at the clinic by veterinary professionals
  • Reduced canine OA pain, which led to increased activity and improved quality of life2-5*

*Results from clinical studies conducted in the US and EU.2,3
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ABOUT LIBRELA

A New Era in Pain Management

Librela is the first and only monthly anti-NGF monoclonal antibody injection to provide long-term canine OA pain control.
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Effectively controls canine OA pain with a monthly injection
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Works differently than NSAIDs by reducing NGF effects, a key factor in canine OA pain6-8
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Approved as safe and is metabolized and eliminated like naturally occurring antibodies, with minimal involvement of the liver or kidneys1,9,10
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Reduced canine OA pain, which led to increased activity and improved quality of life2-5*

*Results from clinical studies conducted in the US and EU.2,3

NGF=nerve growth factor; NSAID=nonsteroidal anti-inflammatory drug.
MECHANISM OF ACTION (MOA)

Librela Targets OA Pain With a Unique MOA
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Librela is a monoclonal antibody (mAb)

  • It is a potent inhibitor of canine NGF activity, a key OA pain mediator, thus reducing canine OA pain6-8

Librela binds to NGF, and its action helps to7,11:

  • Reduce canine OA pain
  • Limit the release of additional NGF and pro-inflammatory mediators
  • Lower neurogenic inflammation

See How It Works

Unlike daily oral pain medications used to treat OA pain, Librela is a monthly injection that provides long-lasting control of OA pain.

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EFFICACY

Efficacy Your Canine Patients Need

In 2 clinical studies conducted in the US and EU with a total of 559 dogs, Librela was shown to reduce canine OA pain, which can improve overall quality of life.3-5

Librela Treatment Success
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Day 28 was the prespecified primary effectiveness end point. The European study met statistical significance of difference in treatment success rate between treatment groups at Day 28; the US study did not.

*Secondary end point P values are not adjusted for multiple testing; therefore, caution should be exercised in interpretation as there is potential for inflated Type I error and over-inferring the significance of treatment effect for these time points.

Both studies used the Canine Brief Pain Inventory (CBPI), an owner-completed questionnaire designed to quantify the severity of OA pain and the impact of that pain on the activity of dogs. The CBPI is a clinically validated measurement that assesses pain severity, pain interference (activity), and overall quality of life.4,5

The percentage of dogs considered treatment successes based on the owner CBPI assessment was greater in the Librela group compared to the control group for all assessments in both studies. While effectiveness may not be seen until after the second dose of Librela, some dogs may experience a reduction in pain as early as 7 days after the first dose.

Dogs treated with Librela showed improvement in all 3 measures of the CBPI.

Dogs treated with Librela showed improvement in all 3 measures of the CBPI.

The percentage of dogs considered treatment successes based on the owner CBPI assessment was greater in the Librela group compared to the control group for all assessments in both studies. While effectiveness may not be seen until after the second dose of Librela, some dogs may experience a reduction in pain as early as 7 days after the first dose.

View the CBPI scale

Librela Was Demonstrated to Be Well-Tolerated and Provided Continued Canine OA Pain Control3
  • The effectiveness of Librela was further evaluated in a subset of 89 dogs from the EU clinical study for a total of 9 months
  • The CBPI indicated that Librela, given once monthly for 9 months, was demonstrated to be well tolerated and provided continued canine OA pain control. It also showed improvement in the overall impression of quality of life for dogs in the study

SAFETY

Librela Is Approved as Safe and Effective1

Two clinical studies showed that adverse events for the 273 Librela-treated dogs were similar to what would be expected for this population of dogs with OA.1-3,12
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Librela is eliminated via normal protein degradation pathways—just like naturally produced antibodies—with minimal metabolism by the liver or kidneys.9,10

DOSING & STORAGE

Canine OA Pain Control Is in Your Hands

Librela is administered subcutaneously once a month by veterinary professionals.

The recommended dose of Librela is 0.23 mg/lb (0.5 mg/kg) body weight.
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For dogs <11 lb (<5 kg): Aseptically withdraw 0.045 mL/lb (0.1 mL/kg) from a 5 mg/mL vial into a single syringe and administer immediately. Discard the vial after the dose has been withdrawn.

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For dogs ≥11 lb (≥5 kg): Dogs should be dosed by weight range according to the Librela dosing chart. Dogs are given the full content of 1 or 2 vials of the appropriate concentration based on body weight. Aseptically withdraw the total dose into a single syringe and administer immediately.
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Librela should be stored in a refrigerator between 36 °F to 46 °F (2 °C to 8 °C). Do not freeze. Store vials in their boxes to protect from prolonged exposure to light.

 

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Once punctured, contents of the vial should be used immediately, and any remaining solution should be discarded.

Dosing

The recommended dose of Librela is 0.23 mg/lb (0.5 mg/kg) body weight.

Meduim Dog Icon

For dogs <11 lb (<5 kg): Aseptically withdraw 0.045 mL/lb (0.1 mL/kg) from a 5 mg/mL vial into a single syringe and administer immediately. Discard the vial after the dose has been withdrawn.

Large Dog Icon

For dogs ≥11 lb (≥5 kg): Dogs should be dosed by weight range according to the Librela dosing chart. Dogs are given the full content of 1 or 2 vials of the appropriate concentration based on body weight. Aseptically withdraw the total dose into a single syringe and administer immediately.

Storage

Temperature Icon

Librela should be stored in a refrigerator between 36 °F to 46 °F (2 °C to 8 °C). Do not freeze. Store vials in their boxes to protect from prolonged exposure to light.

Syringe Icon

Once punctured, contents of the vial should be used immediately, and any remaining solution should be discarded.
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View and download the Librela dosing chart
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Get a Canine OA Pain Checklist for your clients

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View tips about examining dogs for OA
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Find out more about the New Science of OA Pain

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References:

  1. Librela (bedinvetmab injection). Freedom of Information Summary. NADA 141-562. Zoetis Inc; May 2023.
  2. Michels GM, Honsberger NA, Walters RR, Tena JKS, Cleaver DM. A prospective, randomized, double-blind, placebo-controlled multisite, parallel-group field study in dogs with osteoarthritis conducted in the United States of America evaluating bedinvetmab, a canine anti-nerve growth factor monoclonal antibody. Vet Anaesth Analg. 2023;50(5):446-458. doi:10.1016/j.vaa.2023.06.003
  3. Corral MJ, Moyaert H, Fernandes T, et al. A prospective, randomized, blinded, placebo-controlled multisite clinical study of bedinvetmab, a canine monoclonal antibody targeting nerve growth factor, in dogs with osteoarthritis. Vet Anaesth Analg. 2021;48:943-955. doi:10.1016/j.vaa.2021.08.001
  4. Brown DC, Boston RC, Coyne JC, Farrar JT. Development and psychometric testing of an instrument designed to measure chronic pain in dogs with osteoarthritis. Am J Vet Res. 2007;68(6):631-637. doi:10.2460/ajvr.68.6.631
  5. Brown DC, Boston RC, Coyne JC, Farrar JT. Ability of the Canine Brief Pain Inventory to detect response to treatment in dogs with osteoarthritis. J Am Vet Med Assoc. 2008;233(8):1278-1283. doi:10.2460/javma.233.8.1278
  6. Isola M, Ferrari V, Miolo A, et al. Nerve growth factor concentrations in the synovial fluid from healthy dogs and dogs with secondary osteoarthritis. Vet Comp Orthop Traumatol. 2011;24(4):279-284. doi:10.3415/VCOT-10-04-0051
  7. Mantyh PW, Koltzenburg M, Mendell LM, Tive L, Shelton DL. Antagonism of nerve growth factor-TrkA signaling and the relief of pain. Anesthesiology. 2011;115(1):189-204. doi:10.1097/ALN.0b013e31821b1ac5
  8. Enomoto M, Mantyh PW, Murrell J, Innes JF, Lascelles BDX. Anti-nerve growth factor monoclonal antibodies for the control of pain in dogs and cats. Vet Rec. 2019;184(1):23. doi:10.1136/vr.104590
  9. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH. Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010;49(8):493-507. doi:10.2165/11531280
  10. Olivry T, Bainbridge G. Advances in veterinary medicine: therapeutic monoclonal antibodies for companion animals. Zoetis. March 2015.
  11. Seidel MF, Wise BL, Lane NE. Nerve growth factor: an update on the science and therapy. Osteoarthritis Cartilage. 2013;21(9):1223-1228. doi:10.1016/j.joca.2013.06.004
  12. Willems A, Paepe D, Marynissen S, et al. Results of screening of apparently healthy senior and geriatric dogs. J Vet Intern Med. 2017;31(1):81-92. doi:10.1111/jvim.14587

All trademarks are the property of Zoetis Services LLC or a related company or a licensor unless otherwise noted.

© 2024 Zoetis Services LLC. All rights reserved. LIB-00011R5

IMPORTANT SAFETY INFORMATION: 

See full Prescribing Information. For use in dogs only. Women who are pregnant, trying to conceive or breastfeeding should take extreme care to avoid self-injection. Hypersensitivity reactions, including anaphylaxis, could potentially occur with self-injection. LIBRELA should not be used in breeding, pregnant or lactating dogs. LIBRELA should not be administered to dogs with known hypersensitivity to bedinvetmab. The most common adverse events reported in a clinical study were urinary tract infections, bacterial skin infections and dermatitis.

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IMPORTANT SAFETY INFORMATION: 

See full Prescribing Information. For use in dogs only. Women who are pregnant, trying to conceive or breastfeeding should take extreme care to avoid self-injection. Hypersensitivity reactions, including anaphylaxis, could potentially occur with self-injection. LIBRELA should not be used in breeding, pregnant or lactating dogs. LIBRELA should not be administered to dogs with known hypersensitivity to bedinvetmab. The most common adverse events reported in a clinical study were urinary tract infections, bacterial skin infections and dermatitis.