[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"notifications-list":3,"$fsgs40py7ojlw":5},{"data":4},[],{"data":6,"error":10},{"id":7,"documentId":8,"slug":9,"name":9,"proprietary_name":10,"non_proprietary_name":10,"is_proprietary":10,"active_ingredient":10,"administration_route":10,"available_strength":10,"dosage_form":10,"dose_schedule":10,"drug_unit":10,"is_available_generically":10,"mechanism_of_action":10,"overdosage":10,"warning":10,"species":11,"citations":12,"dose_schedules":27,"available_strengths":33,"label_statements":37,"drug_classes":58,"specialties":59,"medical_conditions":60,"animal_species":61},1642,"hzmp7gorilaufobh83gu7z3a","bexagliflozin",null,[],[13,19,23],{"source":14,"licence":15,"source_url":16,"harvested_by":17,"retrieved_at":18},"EMA centrally authorised medicines","EMA reuse with attribution","https:\u002F\u002Fwww.ema.europa.eu\u002Fen\u002Fdocuments\u002Freport\u002Fmedicines-output-medicines-report_en.xlsx","load-reference-corpus.cjs","2026-09-07",{"source":20,"licence":21,"source_url":22,"harvested_by":17,"retrieved_at":18},"FDA Green Book","US public domain","https:\u002F\u002Fanimaldrugsatfda.fda.gov\u002Fadafda\u002Fapp\u002Fsearch\u002Fpublic\u002FingredientsInformationExcel\u002FSection2ActiveIngredients",{"source":24,"licence":25,"source_url":26,"harvested_by":17,"retrieved_at":18},"UK VMD PID","OGL v3.0","https:\u002F\u002Fwww.vmd.defra.gov.uk\u002Fproductinformationdatabase\u002Fdownloads\u002Fvmd_productinformationdatabase.xlsx",[28],{"id":29,"dose_text":30,"species":10,"administration_route":31,"limitation":10,"source_label":32},11298,"Always provide the Client Information Sheet with the prescription.\nDosing Instructions\nAdminister 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.\nMonitoring\n•Sudden onset of hyporexia\u002Fanorexia, 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.\n•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.\noIncreasing or persistently elevated feline pancreas-specific lipase or liver parameters should prompt further evaluation for pancreatitis and\u002For hepatic disease and consideration for discontinuing Bexacat.\noBHBA 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.\noCats with increasing or persistently elevated cholesterol and triglyceride levels may be at an increased risk for developing diabetic ketoacidosis or euglycemic diabetic ketoacidosis.\noBexacat should be discontinued if poor glycemic control, as described below, develops.\n•During the first 8 weeks after initiation of Bexacat, assessment of glycemic control and clinical improvement should be evaluated.\noA physical examination, an 8-hour blood glucose curve, serum fructosamine and body weight should be assessed at 2, 4 and 8 weeks.\noCats demonstrating poor glycemic control, including weight loss, an average blood glucose concentration from an 8-hour blood glucose curve ≥ 250 mg\u002FdL, and\u002For a fructosamine indicating poor glycemic control should be closely monitored.\noBexacat should be discontinued, and initiation of insulin considered in cats demonstrating poor glycemic control, as described above, at 8 weeks.\n•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.\n•Development of diabetic ketoacidosis and euglycemic diabetic ketoacidosis requires the following actions:\noDiscontinuation of Bexacat\noPrompt initiation of insulin therapy\noAdministration of dextrose or other carbohydrate source, regardless of blood glucose concentration\noAppropriate nutritional support should be promptly initiated to prevent or treat hepatic lipidosis.\nFor more information refer to\nCONTRAINDICATIONS\nand\nWARNINGS.","ORAL","Elanco TM Bexacat TM (bexagliflozin tablets)",[34],{"id":35,"strength_text":36,"dosage_form":10,"proprietary_name":10,"species":10,"source_label":32},9919,"15 mg \u002F 1 1",[38,42,46,50,54],{"id":39,"kind":40,"statement":41,"species":10,"limitation":10,"source_label":32},16279,"indication","Bexacat is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.",{"id":43,"kind":44,"statement":45,"species":10,"limitation":10,"source_label":32},16280,"contraindication","•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.\n•Due to risk of severe adverse reactions, do not use Bexacat in cats with evidence of hepatic disease or reduced renal function.",{"id":47,"kind":48,"statement":49,"species":10,"limitation":10,"source_label":32},16281,"warning","User Safety Warnings\nNot for use in humans. Keep out of reach of children. Consult a physician in case of accidental ingestion by humans.\nAnimal Safety Warnings\n•Bexacat should not be initiated in cats with:\noAnorexia, 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.\noAn fPL level > 5.3 mcg\u002FL, diagnostic imaging consistent with pancreatitis, a history of pancreatitis, or current clinical signs suggestive of pancreatitis.\noLaboratory 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).\noA BHBA > 37 mg\u002FdL, or if BHBA is > 25 mg\u002FdL and the cat has a history of renal disease or metabolic acidosis.\n•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\u002For euglycemia despite discontinuation of Bexacat in some cats with hepatic disease and\u002For 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.\n•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\nAdverse Reactions\n). 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.\n•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\nAdverse Reactions\n).\n•Long term use of Bexacat may increase the risk of urothelial carcinoma (see\nAdverse Reactions\n).\n•Keep Bexacat in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.",{"id":51,"kind":52,"statement":53,"species":10,"limitation":10,"source_label":32},16282,"adverse_reaction","Field Study\nEighty-four cats with newly diagnosed diabetes mellitus were enrolled in a 180-day multicenter field effectiveness and safety study. Safety data were evaluated in 84 cats treated with at least one dose of Bexacat. All cats received one tablet, once daily, regardless of body weight or blood glucose level. Seventy-two of the 84 enrolled cats completed the study. The most common adverse reactions included elevated blood urea nitrogen (BUN), vomiting, elevated urine specific gravity (USG), elevated serum fPL, diarrhea, anorexia, lethargy, and dehydration. The adverse reactions seen during the field study are summarized in Table 1 below.\nTable 1. Adverse Reactions (n=84)\n* Most cats had elevations \u003C 1.5 times the upper limit of normal (ULN).\n† Elevations were predominantly attributable to dehydration and\u002For glucosuria.\n‡ Most cats had one or more isolated elevations, followed by a return to previous values.\n§ Of nine cats with elevations ≥ 1.5X ULN, 2 cats developed diabetic ketoacidosis and were transitioned to insulin. One cat developed diabetic ketoacidosis and hepatic lipidosis resulting in death (euthanasia). One cat developed anemia, progressive weight loss and fPL elevations resulting in death.\n** Observations included hiding, agitation, aggression, vocalization, and anxious behavior.\nAdverse Reaction\nNumber (%)\nElevated BUN*\n46 (54.8)\nVomiting\n42 (50.0)\nElevated USG†\n33 (39.3)\nElevated fPL‡\n33 (39.3)\nDiarrhea\n32 (38.1)\nAnorexia\n31 (37.0)\nLethargy\n17 (20.2)\nDehydration\n16 (19.0)\nElevated symmetrical dimethylarginine (SDMA)\n13 (15.5)\nWeight loss\n13 (15.5)\nUrinary tract infection\n12 (14.3)\nElevated ALT and\u002For AST§\n11 (13.1)\nHypercalcemia\n8 (9.5)\nBehavioral changes**\n6 (7.1)\nProteinuria\n5 (6.0)\nElevated creatinine\n4 (4.8)\nElevated creatine kinase\n4 (4.8)\nInappropriate urination\n4 (4.8)\nDeath\n3 (3.6)\nDiabetic ketoacidosis\n3 (3.6)\nPancreatitis\n3 (3.6)\nEuglycemic diabetic ketoacidosis\n2 (2.4)\nHepatic lipidosis\n2 (2.4)\nElevated alkaline phosphatase\n2 (2.4)\nElevated total bilirubin\n2 (2.4)\nConstipation\n2 (2.4)\nNine serious adverse reactions associated with Bexacat administration occurred during the study, including three cats who died or were euthanized. Of the three cats who died or were euthanized, two cats became clinically ill within 5 doses of Bexacat administration (range 3 to 5 doses). One cat with euglycemic diabetic ketoacidosis and hepatic lipidosis was euthanized due to further deterioration of its clinical condition, despite supportive treatment. One cat demonstrating anorexia, lethargy, dehydration, azotemia, and hypokalemia was euthanized without supportive treatment. One cat, who demonstrated a lack of effectiveness, anemia and hepatic lipidosis died on Day 77 despite supportive treatment and additional diagnostics. Six of the nine cats had serious adverse reactions that did not result in death or euthanasia. Five cats were treated for their clinical conditions and transitioned to insulin. Serious adverse reactions in these cats were associated with the following conditions (number of cats): euglycemic diabetic ketoacidosis (1); lack of effectiveness, diabetic ketoacidosis, elevated liver parameters (1); diabetic ketoacidosis (1); diabetic ketoacidosis and pyelonephritis (1); and lack of effectiveness, weight loss, dehydration (1). One cat with constipation and pancreatitis received supportive treatment and remained on Bexacat (bexagliflozin tablets).\nPilot Field Study\nEighty-nine cats with newly diagnosed diabetes mellitus were enrolled in a 56-day multicenter pilot field effectiveness and safety study, with continued use for up to 180 days. All cats received one tablet, once daily, regardless of body weight or blood glucose level. Safety data were evaluated for all 89 cats treated with at least one dose of bexagliflozin. The most common adverse reactions included elevated blood urea nitrogen (BUN), elevated urine specific gravity (USG), elevated serum feline pancreas-specific lipase, vomiting, diarrhea\u002Floose stool, hyporexia\u002Fanorexia, lethargy, elevated serum alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST), and urinary tract infections. The adverse reactions seen in the pilot study are summarized in Table 2 below.\nTable 2. Adverse Reactions (n=89)\n* Most cats had elevations ≤ 1.5X upper limit of normal (ULN).\n† Elevations were predominantly attributable to dehydration and\u002For glucosuria.\n‡ Most cats had one or more isolated elevations, followed by a return to previous values.\n§ Most elevations were ≤ 2X ULN. One cat had marked ALT and AST (9X and 6X upper limit of normal, respectively) elevations on Day 28. Following discontinuation of bexagliflozin, the liver enzymes decreased within 24 hours and returned to within reference range in 10 days.\n** Observations included hiding, hyperactivity, vocalization, and abnormal behavior.\nAdverse Reaction\nNumber (%)\nElevated BUN*\n51 (57.3)\nElevated USG†\n43 (48.3)\nElevated fPL‡\n39 (43.8)\nVomiting\n39 (43.8)\nDiarrhea\u002FLoose Stool\n29 (32.6)\nHyporexia\u002FAnorexia\n28 (31.4)\nLethargy\n16 (18.0)\nElevated ALT and\u002For AST§\n13 (14.6)\nUrinary tract infection\n13 (14.6)\nDehydration\n10 (11.2)\nElevated symmetrical dimethylarginine (SDMA)\n10 (11.2)\nBehavioral changes**\n9 (10.1)\nKetosis\u002FKetonuria\n8 (9.0)\nWeight loss\n8 (9.0)\nProteinuria\n8 (9.0)\nPancreatitis\n7 (7.9)\nDeath\n6 (6.7)\nAnemia\n6 (6.7)\nHepatopathy\n6 (6.7)\nHypercalcemia\n4 (4.5)\nElevated creatine kinase\n4 (4.5)\nInappropriate urination\n4 (4.5)\nPeritonitis\n3 (3.4)\nConstipation\n3 (3.4)\nElevated creatinine\n2 (2.2)\nEuglycemic diabetic ketoacidosis\n2 (2.2)\nDiabetic ketoacidosis\n2 (2.2)\nHemolytic anemia\n2 (2.2)\nElevated total bilirubin\n2 (2.2)\nTwenty cats (22%) had at least one blood glucose value \u003C 65 mg\u002FdL recorded during 8-hour blood glucose curves. No clinical signs of hypoglycemia were observed and bexagliflozin dosing was not adjusted in any cat due to documented hypoglycemia. Nine serious adverse reactions associated with bexagliflozin administration occurred during the study, including six cats who died or were euthanized. Of the six cats who died or were euthanized, five became clinically ill within receiving 5 doses of bexagliflozin (range 1 to 5 doses). Four of the cats were euthanized due to further deterioration of their clinical condition despite supportive treatment. One cat died despite supportive treatment. Deaths were associated with the following conditions (number of cats): necrotizing pancreatitis and pancreatic abscess (1), pancreatitis and hepatic lipidosis (1), euglycemic diabetic ketoacidosis and severe hepatic lipidosis (1), pancreatitis and hepatic abscesses (1), diabetic ketoacidosis (1), and persistent polyuria and polydipsia and quality of life concerns (1).\nThree of nine serious adverse reactions that did not result in death or euthanasia included the following (number of cats): acute hepatocellular injury (1), immune-mediated hemolytic anemia (1), and euglycemic diabetic ketoacidosis with concurrent pancreatitis and hepatopathy (1). Two cats with serious adverse reactions demonstrated persistent bexagliflozin blood plasma levels and elimination half-lives after discontinuation of bexagliflozin. One cat with renal and liver values within the reference range at screening was euthanized due to a continued decline in clinical condition despite treatment for euglycemic diabetic ketoacidosis and severe hepatic lipidosis. The second cat, noted to have IRIS (International Renal Interest Society) stage II renal disease and liver values within the reference range at screening, recovered following treatment for marked liver enzyme elevations above the reference range on Day 28.\nExtended Use Field Study\nOne hundred twenty-five cats with diabetes mellitus that had previously completed a bexagliflozin field study were enrolled in a multicenter extended use field study. Cats were enrolled in the study for a range of 7 to 1064 days, with a mean of 329 days. Safety data were evaluated for all 125 cats treated with at least one dose of Bexacat (bexagliflozin tablets). All cats received one tablet, once daily, regardless of body weight or blood glucose level. Forty-nine of the 125 enrolled cats were withdrawn from the study due to adverse reactions, serious adverse reactions, death\u002Feuthanasia, lack of effectiveness, suspected diabetic remission, withdrawal of owner consent, or lost to follow up. The most common adverse reactions were similar to those noted in the previous field studies and included elevated USG (35.2%), vomiting (27.2%), elevated fPL (26.4%), anorexia (24.0%), diarrhea (22.4%), urinary tract infections (17.6%), lethargy (16.8%), and death (16.0%).\nTwenty serious adverse reactions associated with Bexacat administration occurred during the study, all resulting in death or euthanasia. Clinical signs of hypoglycemia were observed in two of these cats. Deaths were associated with the following conditions (number of cats), with some cats experiencing multiple comorbidities (necropsy was not granted in all cases): euglycemic diabetic ketoacidosis (8); diabetic ketoacidosis (4); hepatic lipidosis (5); pancreatic necrosis\u002Fperipancreatic fat saponification (3); urothelial carcinoma (2); hypercalcemia, recurrent calcium containing cystic calculi (1); lack of effectiveness, weight loss, anorexia (1); lethargy, weight loss, pallor (1); chronic renal disease, glomerulonephritis (1); chronic enteropathy (1); hypoglycemia, possible pancreatitis (1).",{"id":55,"kind":56,"statement":57,"species":10,"limitation":10,"source_label":32},16283,"mechanism_of_action","Mechanism of Action\nBexagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2), the renal transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, bexagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion.\nPharmacokinetics\nIn a laboratory pilot study conducted to determine the prandial state of maximum exposure, systemic exposure for bexagliflozin was greater in the fasted state than in the fed state by 82% for the mean maximum observed plasma concentration (Cmax), and by 54% for the mean area under the plasma concentration versus time curve (AUC) from dosing (time 0) to the last quantifiable concentration (AUC0-last), respectively.\nIn a well-controlled margin of safety study (see\nTarget Animal Safety\n), mean Cmax was approximately dose-proportional over a dosage range of 5 mg\u002Fkg (1X) to 25 mg\u002Fkg (5X). Mean AUC from time 0 to 24 hours exposure was approximately dose-proportional over a dosage range of 5 to 15 mg\u002Fkg, but more than dose-proportional at 15 to 25 mg\u002Fkg. An increase in exposure (AUC0-24 and Cmax), was observed in female cats compared to male cats on all evaluation days. Median time to reach peak plasma concentration (Tmax) was approximately 0.5 hours (range 0.5 to 2 hours) and mean half-life (T1\u002F2) was approximately 5 hours across all dose groups. There was no accumulation of bexagliflozin following daily dosing of 5, 15, and 25 mg\u002Fkg in healthy non-diabetic cats. However, field studies showed that some diabetic cats had persistent bexagliflozin blood levels after discontinuation of the drug, which may be related to a decrease in liver function in some cats (see\nAnimal Safety Warnings\n).",[],[],[],[]]