Regulatory product record
LIBRELA
Product identity, ingredients and source provenance from the regulatory catalogue. Linked clinical evidence has a separate review status.
Product identity
- Brand name
- LIBRELA
- DIN
- 02511819
- DPD drug code
- 100100
- Regulatory category
- APPROVED_VET_DRUG
- Market status
- MARKETED
- Route(s)
- SUBCUTANEOUS
- Pharmaceutical form(s)
- SOLUTION
- Ingredients
- BEDINVETMAB (15 MG)
- Species (DPD record)
- DOGS
- Company
- ZOETIS CANADA INC (DIN owner)
Source and provenance
- Source dataset
- health_canada_dpd_marketed
- Source snapshot date
- Not available in this source
- Source record key
- 100100
- Archive fingerprint (SHA-256)
- 85cc3ce208af3aa57018c3d14d83f90220c436baef7455384b6d48d9774e1c88
Linked clinical reference
Clinical entries are linked through the active molecule. Check their species, formulation, source and review status separately from this product record.
Clinical evidence
Dose regimens0
No dose regimens recorded for this species selection.
Adverse effects117
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Death by euthanasia2,371 reports
- Lethargy (see also Central nervous system depression in Neurological)2,229 reports
- Polydipsia1,620 reports
- Ataxia1,586 reports
- Vomiting1,533 reports
- Seizure NOS1,532 reports
- Polyuria1,517 reports
- Diarrhoea1,455 reports
- Urinary incontinence1,359 reports
- Death1,221 reports
- Lack of efficacy - NOS1,162 reports
- Limb weakness1,142 reports
Cat
- Prescribing error3 reports
- Accidental exposure2 reports
- Lethargy (see also Central nervous system depression in Neurological)2 reports
- Vomiting2 reports
- Abdominal discomfort1 reports
- Abnormal posture NOS1 reports
- Decreased appetite1 reports
- Diarrhoea1 reports
- Elevated alanine aminotransferase (ALT)1 reports
- General pain (see other SOCs for specific pain)1 reports
- Itching1 reports
- Limb weakness1 reports
Literature references15
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Bedinvetmab (Librela/Beransa) in dogs raises safety concerns, including rapidly progressive osteoarthritis, and warrants vigilant adverse event reporting.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy of bedinvetmab on pain, activity, and body composition in obese dogs with osteoarthritis: A randomized double-blind placebo-controlled trial.
Study summary not available in the imported record. Open the original citation to review the study.
- A critical appraisal of the safety of bedinvetmab (Beransa), a canine antinerve growth factor monoclonal antibody.
Study summary not available in the imported record. Open the original citation to review the study.
- Bedinvetmab, alone or in combination with photobiomodulation and pulsed electromagnetic field therapy, on pain and quality of life in dogs with hip osteoarthritis.
Study summary not available in the imported record. Open the original citation to review the study.
- A noninferiority trial evaluating the efficacy of bedinvetmab compared to grapiprant for osteoarthritis-pain in dogs using force plate gait analysis.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.