Bedinvetmab

Indications

LIBRELA is indicated for the control of pain associated with osteoarthritis in dogs.

Dosage and Administration

Always provide the Client Information Sheet and discuss potential adverse drug events with the dog owner prior to administering each injection of LIBRELA (see Post-Approval Experience and Information for Dog Owners). The minimum target dose of LIBRELA is 0.23 mg/lb (0.5 mg/kg) body weight, administered subcutaneously once a month. Dogs should be dosed by weight range according to the specific dosing information below. The product does not contain a preservative. The full content of each vial is for single-use only. Once punctured, contents of the vial should be used immediately and any remaining solution should be discarded. Dogs weighing ≥ 11 lb (≥ 5 kg): Dogs should be dosed by weight range according to the Dosing Table below (Table 1). 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. Table1. Dosing Table Number and Strength (mg/mL) of LIBRELA Vials to be Administered Dog Body Weight in Pounds (lb) Dog Body Weight in Kilograms (kg) 5 mg/mL orange 10 mg/mL blue 15 mg/mL green 20 mg/mL gold 30 mg/mL purple 11-22.1 5-10 1 vial 22.2-44.1 10.1-20 1 vial 44.2-66.1 20.1-30 1 vial 66.2-88.2 30.1-40 1 vial 88.3-132.3 40.1-60 1 vial 132.4-176.4 60.1-80 2 vials 176.5-220.5 80.1-100 1 vial 1 vial 220.6-264.6 100.1-120 2 vials Dogs < 11 lb: Aseptically withdraw 0.045 mL/lb (0.1 mL/kg) from a 5 mg/mL vial (orange vial) into a single syringe and administer immediately. Discard the vial after the dose has been withdrawn. Effectiveness may not be achieved until after the second dose (see EFFECTIVENESS ).

Contraindications

LIBRELA should not be administered to dogs with known hypersensitivity to bedinvetmab. LIBRELA should not be used in breeding dogs or in pregnant or lactating dogs. Immunoglobulin G class antibodies such as LIBRELA can pass through the placental blood barrier and be excreted in milk. Fetal abnormalities, increased rates of stillbirths and increased postpartum fetal mortality were noted in rodents and primates receiving anti-NGF monoclonal antibodies.

Warnings

User Safety Warnings Not for use in humans. Keep this and all drugs out of reach of children. For use in dogs only. Hypersensitivity reactions, including anaphylaxis, could potentially occur in the case of accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet, vial or carton to the physician. Pregnant women, women trying to conceive, and breastfeeding women should take extreme care to avoid accidental self-injection. The importance of Nerve Growth Factor in ensuring normal fetal nervous system development is well-established and laboratory studies conducted on nonhuman primates with human anti-NGF antibodies have shown evidence of reproductive and developmental toxicity.

Precautions

Administration of monoclonal antibodies may be associated with hypersensitivity reactions and delayed hypersensitivity reactions. If anaphylaxis or other hypersensitivity reaction occurs, discontinue use and institute appropriate therapy. The safe use of this product with other monoclonal antibodies has not been evaluated. Use with caution in dogs with known hypersensitivity to other immunoglobulin therapy. Evaluations were not made to determine if interactions occurred between LIBRELA and veterinary vaccines. Treatment with LIBRELA may result in the formation of anti-bedinvetmab antibodies and potentially the loss of product effectiveness (see IMMUNOGENICITY ). The safe use of anti-NGF monoclonal antibodies with concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) has not been established in dogs. In human clinical trials, rapidly progressing osteoarthritis (RPOA) has been reported in a small number of patients receiving humanized anti-NGF monoclonal antibody therapy. The incidence of these events increased in human patients receiving NSAID treatment long term in combination with an anti-NGF monoclonal antibody. RPOA has not been characterized or reported in dogs. The safety and effectiveness of LIBRELA has not been evaluated in dogs less than 12 months of age. LIBRELA has not been studied in dogs that have a history of cruciate ligament rupture within six months before initial product use as these cases were excluded from the field studies. Long term effects which may occur more than 9 months after the use of LIBRELA have not been evaluated. NGF is expressed within the heart and vasculature, and the long-term effects of reduced NGF in dogs with cardiac disease are unknown. Primates receiving high doses of anti-NGF monoclonal antibodies had anatomical changes in postganglionic cell bodies (reduced size and number of neurons). The change in cell body size returned to normal after anti-NGF monoclonal antibody administration was discontinued. NGF is involved in the normal development of sensory and sympathetic nerve fibers in developing animals. This may be important with use of LIBRELA in young growing dogs.

Adverse Reactions

The safety of LIBRELA was assessed in a masked, controlled 84-day US field study evaluating the effectiveness of LIBRELA for the control of pain associated with osteoarthritis. Enrollment included 272 dogs, 135 dogs treated with LIBRELA and 137 dogs treated with a negative control (sterile saline). The enrolled dogs were at least 1 year of age (1 to 17 years old), weighed between 1.8 to 62.7 kg and were of various breeds or non-purebred. Dogs were dosed at 28-day intervals and received up to three injections. The most common adverse reactions reported during the study are summarized in Table 2 below. Table 2. Number (%) of Dogs with Adverse Reactions Reported in the US Field Study Adverse Reaction* LIBRELA n (%) (Total N = 135) Negative Control n (%) (Total N = 137) Urinary tract infection 15 (11.1) 11 (8.0) Bacterial skin infection 11 (8.1) 9 (6.6) Dermatitis 10 (7.4) 8 (5.8) Dermal mass 8 (5.9) 5 (3.6) Erythema 6 (4.4) 5 (3.6) Dermal cyst(s) 4 (3.0) 2 (1.5) Pain on injection 4 (3.0) 2 (1.5) Inappropriate urination** 4 (3.0) 1 (0.7) Histiocytoma 3 (2.2) 0 (0.0) *An adverse reaction may have occurred more than once in a dog; only the first occurrence was counted. ** Of these, two dogs treated with LIBRELA were among those reported with a urinary tract infection. The safety of LIBRELA was also evaluated in a masked, controlled 84-day European field study evaluating the effectiveness of LIBRELA for the control of pain associated with osteoarthritis. Enrollment included 281 dogs, 138 dogs were treated with LIBRELA and 143 treated with a negative control (sterile saline). The enrolled dogs were at least 1 year of age (1 to 17.5 years old), weighed between 1.7 to 66 kg and were of various breeds or non-purebred. Dogs were dosed at 28-day intervals and received up to three injections. The most common adverse reactions reported during the study are summarized in Table 3 below. Table 3. Number (%) of dogs with Adverse Reactions Reported in the European Field Study Adverse Event Reported* LIBRELA n (%) (Total N = 138) Negative Control n (%) (Total N = 143) Increased Blood Urea Nitrogen 19 (13.8) 7 (4.9) (BUN)** 19 (13.8) 7 (4.9) Lethargy 5 (3.6) 0 (0.0) Emesis 4 (2.9) 1 (0.7) Anorexia 3 (2.2) 0 (0.0) Lameness 3 (2.2) 1 (0.7) Cough 3 (2.2) 1 (0.7) *An adverse reaction may have occurred more than once in a dog; only the first occurrence was counted. ** Two dogs treated with LIBRELA suffered serious adverse events and were euthanized during or after study completion: A 13-year old Bichon Frise had pre-existing increased urine protein-creatinine ratio and heart failure that worsened during study; the dog also had an increase in creatinine during the study and was diagnosed with renal failure and was euthanized 3 days after completing the study. An 8-year-old mixed breed dog had pancreatitis and was euthanized on Day 74. The remainder of the dogs that had elevations in the BUN did not have any obvious adverse events associated with this finding. One dog in the LIBRELA group was diagnosed with pyelonephritis on Day 15; this dog had pre-existing increased serum BUN and creatinine and a recent history of urinary tract infection that was not confirmed resolved prior to enrollment. Non-steroidal anti-inflammatory drugs (NSAIDs) and acetaminophen were initiated on Day 7 for osteoarthritis-associated joint pain but NSAIDs were discontinued on Day 10 due to anorexia and gastroenteritis; azotemia worsened at Day 13 and the dog received no further LIBRELA treatment. One dog in the LIBRELA group with a history of atopy, developed mild alopecia and mild erythema on the injection site on Days 5 and 23. Both episodes of alopecia and erythema resolved with treatment. A total of 89 dogs were enrolled in a 6-month, single arm, open labeled, uncontrolled continuation of the EU field study and received monthly subcutaneous injections of LIBRELA. The study provided additional field safety information. One dog experienced acute gastroenteritis and recovered following treatment for abdominal pain, fever, vomiting, and anorexia. One large breed dog enrolled for stifle osteoarthritis developed acute forelimb lameness that was diagnosed as elbow dysplasia. Two dogs presented with rear limb paresis of unknown etiology, one of whom responded to ongoing NSAID treatment and one who did not. Post-Approval Experience (2025) The following adverse events are based on post-approval adverse drug experience reporting for LIBRELA. Not all adverse events are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events in dogs are categorized in order of decreasing reporting frequency by body system and in decreasing order of reporting frequency within each body system: Neurological : ataxia, seizures, paresis, proprioception deficits, paralysis General : anorexia, lethargy, recumbency Urinary : polydipsia, polyuria/pollakiuria, urinary incontinence Gastrointestinal : vomiting, diarrhea Musculoskeletal : muscle weakness, muscle tremors, lameness In some cases, death (including euthanasia) has been reported as an outcome of the adverse events listed above.

Description

LIBRELA (bedinvetmab injection) is a sterile injectable solution containing 5, 10, 15, 20, or 30 mg/mL of bedinvetmab in 20 mM histidine buffer pH 5.0 [(0.027% w/v L- histidine and 0.382% w/v histidine HCl monohydrate), 8.5% w/v trehalose dihydrate, 0.005% w/v disodium EDTA dihydrate, 0.01% w/v L-methionine, and 0.1% w/v poloxamer 188]. Bedinvetmab is a canine IgG monoclonal antibody (mAb), in which the variable regions from canine B cell sequence were joined with canine IgG constant sequences, and is expressed through recombinant DNA techniques in Chinese hamster ovary (CHO) cells. Bedinvetmab binds to nerve growth factor (NGF) to reduce NGF’s effects. Such mAbs are commonly referred to as anti-NGF mAbs.

Information for Owners

Always provide and review the Client Information Sheet with the dog owner prior to each injection of LIBRELA. Advise owners of the adverse reactions that may occur following the administration of LIBRELA including balance problems, trouble walking, weakness, trouble standing, seizures, drinking more, urinating more, loss of bladder control, vomiting, and diarrhea. Owners should be advised to contact their veterinarian if any of these signs or other signs of illness are observed. Advise dog owners that serious adverse reactions can occur and result in death or euthanasia (see Adverse Reactions and Post-Approval Experience ). Where a dog has not been able to exercise prior to treatment with LIBRELA, there is an increased risk of injury if the dog becomes more active after being treated with LIBRELA. Discuss an exercise plan with the dog owner to return the dog to activity.

Storage

LIBRELA (bedinvetmab injection) should be stored in a refrigerator, 2° – 8°C (36° – 46° F). Do not freeze. Store vials in their boxes to protect from prolonged exposure to light. Once punctured, contents of the vial should be used immediately and any remaining solution should be discarded.

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming bedinvetmab as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.