BEXACAT- bexagliflozin tablets tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BEXAGLIFLOZIN (UNII: EY00JF42FV) (BEXAGLIFLOZIN - UNII:EY00JF42FV)

Available from:

Elanco US Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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:

Product summary:

Flavored tablet each containing 15 mg bexagliflozin; 30 or 90 tablets per bottle. Approved by FDA under NADA # 141-566 Manufactured for: Elanco US Inc, Greenfield, IN 46140 Bexacat, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2022 Elanco or its affiliates September 2022 PA103742

Authorization status:

New Animal Drug Application

Summary of Product characteristics

BEXACAT- BEXAGLIFLOZIN TABLETS TABLET
ELANCO US INC.
----------
_ELANCO_
BEXACAT
(BEXAGLIFLOZIN TABLETS)
15 mg flavored tablets
For oral use in cats only
Sodium-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
-
-
-
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:
TM
TM
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).
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,