بيدينفيتماب

For the control of pain associated with osteoarthritis in dogs.

Librela™

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

Librela™

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.

Librela™

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.

Librela™

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.

Librela™

Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection.

Subcutaneous

Librela™

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).

SUBCUTANEOUS

Librela™