This page reprints a manufacturer label. Everything below in quotation marks is copied from Elanco TM Bexacat TM (bexagliflozin tablets), published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.
This page reprints the FDA label for Elanco TM Bexacat TM (bexagliflozin tablets) by Elanco US Inc, a bexagliflozin product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.
The label
Product: Elanco TM Bexacat TM (bexagliflozin tablets). Manufacturer: Elanco US Inc. FDA Structured Product Label set id f918583d-0337-40da-8da1-1e1320b8d027. Label effective 2026-05-19. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.
Indications
Bexacat is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
Dosage and Administration
Always provide the Client Information Sheet with the prescription. Dosing Instructions Administer one tablet by mouth to cats weighing 6.6 lbs (3.0 kg) or greater once daily, at approximately the same time each day, with or without food, and regardless of blood glucose level. Monitoring • Sudden onset of hyporexia/anorexia, lethargy, dehydration, or weight loss in cats receiving Bexacat should prompt immediate discontinuation of Bexacat and assessment for diabetic ketoacidosis, regardless of blood glucose level. • During treatment with Bexacat, blood glucose, fructosamine, serum β-hydroxybutyrate (BHBA), serum feline pancreas-specific lipase (fPL), liver parameters, serum cholesterol and triglycerides; and body weight and clinical signs should be routinely monitored. o Increasing or persistently elevated feline pancreas-specific lipase or liver parameters should prompt further evaluation for pancreatitis and/or hepatic disease and consideration for discontinuing Bexacat. o BHBA is the predominate ketoacid in diabetic ketoacidosis. Bexacat should be discontinued if a notable reduction in BHBA is not observed after initiation of Bexacat, or if BHBA persistently rises after an initial reduction. o Cats with increasing or persistently elevated cholesterol and triglyceride levels may be at an increased risk for developing diabetic ketoacidosis or euglycemic diabetic ketoacidosis. o Bexacat should be discontinued if poor glycemic control, as described below, develops. • During the first 8 weeks after initiation of Bexacat, assessment of glycemic control and clinical improvement should be evaluated. o A physical examination, an 8-hour blood glucose curve, serum fructosamine and body weight should be assessed at 2, 4 and 8 weeks. o Cats demonstrating poor glycemic control, including weight loss, an average blood glucose concentration from an 8-hour blood glucose curve ≥ 250 mg/dL, and/or a fructosamine indicating poor glycemic control should be closely monitored. o Bexacat should be discontinued, and initiation of insulin considered in cats demonstrating poor glycemic control, as described above, at 8 weeks. • Cats may present with diabetic ketoacidosis and a normal blood glucose concentration (euglycemic diabetic ketoacidosis). Delay in recognition and treatment of diabetic ketoacidosis and euglycemic diabetic ketoacidosis may result in increased morbidity and mortality. • Development of diabetic ketoacidosis and euglycemic diabetic ketoacidosis requires the following actions: o Discontinuation of Bexacat o Prompt initiation of insulin therapy o Administration of dextrose or other carbohydrate source, regardless of blood glucose concentration o Appropriate nutritional support should be promptly initiated to prevent or treat hepatic lipidosis. For more information refer to
Contraindications
and WARNINGS . CONTRAINDICATIONS • Do not use Bexacat in cats with diabetes mellitus who have previously been treated with insulin, who are receiving insulin, or in cats with insulin-dependent diabetes mellitus. The use of Bexacat in cats with insulin-dependent diabetes mellitus, or the withdrawal of insulin and initiation of Bexacat, is associated with an increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis and death. • Due to risk of severe adverse reactions, do not use Bexacat in cats with evidence of hepatic disease or reduced renal function.
Warnings
User Safety Warnings Not for use in humans. Keep out of reach of children. Consult a physician in case of accidental ingestion by humans. Animal Safety Warnings • Bexacat should not be initiated in cats with: o Anorexia, dehydration, or lethargy at the time of diagnosis of diabetes mellitus, as it may indicate the presence of other concurrent disease and increase the risk of diabetic ketoacidosis. o An fPL level > 5.3 mcg/L, diagnostic imaging consistent with pancreatitis, a history of pancreatitis, or current clinical signs suggestive of pancreatitis. o Laboratory values consistent with diabetic ketoacidosis, including elevated urine or serum ketones, and metabolic acidosis (high anion gap, or decreased bicarbonate, pH, or partial pressure carbon dioxide [PaCO2] levels). o A BHBA > 37 mg/dL, or if BHBA is > 25 mg/dL and the cat has a history of renal disease or metabolic acidosis. • Persistent plasma bexagliflozin concentrations and reduced clearance of Bexacat, represented as the presence of plasma half-lives in excess of 24 hours, may result in prolonged clinical effects such as glucosuria and/or euglycemia despite discontinuation of Bexacat in some cats with hepatic disease and/or reduced renal function, including cats with clinically undetectable disease at the time of Bexacat initiation. Reduced clearance of Bexacat may contribute to persistent glucosuria, resulting in an osmotic diuresis and dehydration that requires appropriate hydration support. These cats may require hospitalization, which may be protracted, for sequalae such as diabetic ketoacidosis, euglycemic diabetic ketoacidosis, or hepatic lipidosis. • Cats should be screened for urinary tract infections and treated, if indicated, when initiating Bexacat. Treatment with Bexacat may increase the risk for urinary tract infections (see
Precautions
• Bexacat should be discontinued in cats who develop diarrhea unresponsive to conventional therapy. • Consider temporary discontinuation of Bexacat in cats during times of decreased caloric intake, such as surgery or decreased appetite, as administration of Bexacat in these cats may increase the risk of diabetic ketoacidosis or hepatic lipidosis. • The osmotic diuretic effects of Bexacat may contribute to inappropriate urination in some cats (see
Adverse Reactions
). Cats treated with Bexacat should be monitored for urinary tract infections and treated promptly. Consider discontinuation of Bexacat in cats with recurrent urinary tract infections. • Bexacat may cause increased serum calcium concentrations. Bexacat should be discontinued in cats with persistent increases in serum total calcium or ionized calcium because of increased risk of forming calcium containing uroliths (see Adverse Reactions ). • Long term use of Bexacat may increase the risk of urothelial carcinoma (see Adverse Reactions ). • Keep Bexacat in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
Description
Bexacat (bexagliflozin tablets) are flavored pentagonal, 10 mm, speckled white, brown, or tan biconvex with a characteristic odor. The empirical formula is C24H29ClO7 and the molecular weight is 464.94 g/mol. The chemical name is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-(2-cyclopropoxyethoxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol. The chemical structure of bexagliflozin is: chemical structure
Information for Owners
Owners should be given the Client Information Sheet to read before Bexacat is administered. Owners should be advised to discontinue Bexacat and contact a veterinarian immediately if their cat develops anorexia, lethargy, vomiting, diarrhea, or weakness.
Storage
Bexacat should be stored at room temperature 68 to 77 ˚F (20 to 25 °C).
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 bexagliflozin 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.
Dogs: 18 reports
| VeDDRA reaction term | Reports |
|---|---|
| Glucosuria | 9 |
| Accidental exposure | 6 |
| Inappropriate urination | 3 |
| Urinary tract infection | 3 |
| Fanconi syndrome | 2 |
| Haematuria | 2 |
| Polydipsia | 2 |
| Polyuria | 2 |
| Proteinuria | 2 |
| Vomiting | 2 |
| Behavioural disorder NOS | 1 |
| Coprophagia | 1 |
| Drinking a lot | 1 |
| Elevated blood urea nitrogen (BUN) | 1 |
| Emesis | 1 |
Outcome as recorded by the reporter: Ongoing 8; Outcome Unknown 8; Recovered/Normal 2.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Cats: 3,770 reports
| VeDDRA reaction term | Reports |
|---|---|
| Ketosis | 1,470 |
| Weight loss | 1,017 |
| Hyperglycaemia | 847 |
| Diarrhoea | 722 |
| Lack of efficacy - NOS | 549 |
| Vomiting | 427 |
| Lethargy (see also Central nervous system depression in Neurological) | 421 |
| Hypoglycaemia | 402 |
| Other abnormal test result NOS | 388 |
| Glucosuria | 346 |
| Not eating | 332 |
| Diabetic ketoacidosis | 267 |
| Elevated blood urea nitrogen (BUN) | 246 |
| Weight gain | 245 |
| Death by euthanasia | 243 |
Outcome as recorded by the reporter: Outcome Unknown 1,601; Ongoing 1,582; Recovered/Normal 289; Euthanized 241; Died 65.
Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.
Sources
- Elanco TM Bexacat TM (bexagliflozin tablets)FDA · retrieved 2026-09-16
“Always provide the Client Information Sheet with the prescription.” (Dosage and Administration)
- openFDA Animal and Veterinary Adverse Event ReportsFDA · retrieved 2026-09-16
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From Glarda
The note drafted from the consult, with the reference you just read sitting beside it in the shape your record already expects.