Bexacat: Product Information

BEXACAT- bexagliflozin tablet
Elanco US Inc.

15 mg flavored tablets
For oral use in cats onlySodium-glucose cotransporter 2 (SGLT2) inhibitor

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

WARNING: DIABETIC KETOACIDOSIS/EUGLYCEMIC DIABETIC KETOACIDOSIS

Cats treated with Bexacat may be at an increased risk of diabetic ketoacidosis or euglycemic diabetic ketoacidosis (see Adverse Reactions). As diabetic ketoacidosis and euglycemic diabetic ketoacidosis in cats treated with Bexacat may result in death, development of these conditions should be treated promptly, including insulin administration and discontinuation of Bexacat (see Monitoring).
Due to the risk of developing diabetic ketoacidosis or euglycemic diabetic ketoacidosis, 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 (see Contraindications).
Bexacat should not be initiated in cats with anorexia, dehydration or lethargy at the time of diagnosis of diabetes mellitus or without appropriate screening tests (see Animal Safety Warnings).

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
(click image for full-size original)

INDICATION

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.
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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.
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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.
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Cats with increasing or persistently elevated cholesterol and triglyceride levels may be at an increased risk for developing diabetic ketoacidosis or euglycemic diabetic ketoacidosis.
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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.
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A physical examination, an 8-hour blood glucose curve, serum fructosamine and body weight should be assessed at 2, 4 and 8 weeks.
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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.
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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:
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Discontinuation of Bexacat
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Prompt initiation of insulin therapy
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Administration of dextrose or other carbohydrate source, regardless of blood glucose concentration
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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:
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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.
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An fPL level > 5.3 mcg/L, diagnostic imaging consistent with pancreatitis, a history of pancreatitis, or current clinical signs suggestive of pancreatitis.
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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).
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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 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.
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