Bexatil 15 mg Tablets for Cats

disease or acidosis.
Chronic diarrhoea and associated dehydration should be resolved prior to initiation of
treatment; treatment should be discontinued in cats with diarrhoea that is persistent
and unresponsive to conventional therapy.
Use with caution in cats suffering from pre-existing hepatic or renal disease.
Use with caution in cats with elevated calcium levels.
Use with caution in cats that have a poor appetite, dehydration or lethargy.
Use with caution in cats with elevated feline pancreatic lipase levels. Treatment
should not be initiated in cats with a history of pancreatitis and feline pancreatic
lipase values greater than 5.3 μg/L. Cases of clinical pancreatitis should be resolved
prior to initiation of treatment with bexagliflozin.
Cats with co-morbidities such as hepatic disease, infectious disease, cardiac
disease, elevated blood pressure, feline idiopathic cystitis, renal insufficiency (IRIS
stage 3 or 4), neoplasia and hyperthyroidism were excluded from clinical trials.
Safety and efficacy of the veterinary medicinal product in diabetic cats with these co-
morbidities has not been fully investigated. Use of the veterinary medicinal product in
cats with co-morbidities is only according to the benefit-risk assessment by the
prescribing veterinarian.
Cats should be evaluated for concurrent diseases that may predispose to DKA (e.g.
acromegaly).
Suspected or confirmed DKA, cachexia or dehydration should be resolved prior to
treatment.
Screening and initial monitoring
Screening for DKA must be performed prior to treatment start. Treatment should not
be initiated, or resumed, if ketone bodies at concentrations indicative of DKA are
present. Clinical signs such as unintended or persistent weight loss, acute vomiting,
dehydration, lethargy and anorexia (inappetence) may indicate DKA or a higher risk
of developing DKA. Cats considered to be at risk of developing DKA need close
monitoring and alternative treatment plans should be considered. The risk of
developing DKA decreases after the first two weeks of treatment, but DKA may
occur at any time (for monitoring see below). If treatment start is delayed for more
than four days after diagnosis of diabetes mellitus, the veterinarian should re-assess
the risk for DKA. Check for ketones every 1 to 3 days for the first two weeks of
treatment and whenever clinical signs of illness are seen.
Routine Monitoring
Monitoring for diabetic control, DKA (including evaluation for ketone bodies in blood
and/or urine) and urinary tract infections is recommended at regular intervals by a
veterinarian. Discontinue treatment immediately in the event of confirmed or
suspected DKA or diabetic ketonuria and investigate accordingly.
Due to the mode of action of SGLT2 inhibitors, hyperglycaemia may not be present
in case of DKA (euglycaemic DKA). The diagnosis of euglycaemic DKA needs to be
based on clinical signs, a laboratory finding of metabolic acidosis and other
laboratory findings consistent with DKA. In case of DKA it is imperative to
immediately initiate appropriate treatment, which includes prompt initiation of insulin
therapy, despite normal blood glucose values in euglycaemic DKA. The initiation of
insulin is needed to stop the progression of ketoacidosis.
Delay in diagnosis and treatment of diabetic ketoacidosis and euglycemic diabetic
ketoacidosis may result in increased morbidity and mortality.
Cats may require temporary discontinuation of therapy in clinical situations known to
predispose to ketoacidosis (e.g. anorexia or inappetence due to acute illness or
fasting around surgery).
Special precautions to be taken by the person administering the veterinary medicinal
product to animals

Sodium-glucose co-transporter 2 (SGLT2) inhibitors, such as bexagliflozin, may
cause hypersensitivity reactions. People with known hypersensitivity to bexagliflozin,
or SGLT2 inhibitors, should avoid contact with the veterinary medicinal product. If
symptoms such as a skin rash occur, seek medical advice and show the package
leaflet or the label to the physician.
Accidental ingestion, particularly by children, may cause transient effects such as
glucosuria (increased renal glucose excretion), vomiting and diarrhoea. In case of
accidental ingestion, seek medical advice immediately and show the package leaflet
or the label to the physician.
Wash hands after use.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Cats
Very common
(>1 animal / 10
animals treated):
Vomiting
, Diarrhoea
Urinary tract infection
Decreased appetite, Anorexia, Dehydration
, Lethargy,
Weight loss
High pancreatic-specific lipase
Common
(1 to 10 animals
/ 100 animals
treated):
Diabetic ketoacidosis (DKA)
Diabetic ketonuria
Pancreatitis
Polyuria/Polydipsia
Elevated alanine aminotransferase (ALT)
, Elevated
aspartate aminotransferase (AST)
, Elevated blood urea
nitrogen (BUN)
Hypercalcaemia
Usually sporadic and resolves without specific therapy. Acute or more frequent
vomiting may also be a sign of other severe disease conditions and should be
investigated accordingly.
May be transient. Supportive treatment can help resolve gastrointestinal signs. In
case treatment-related diarrhoea persists, treatment should be discontinued and
alternative treatments considered. See also section 3.5.
Urinary tract infection including cystitis caused by infection: may occur as part of
the underlying disease. The glucosuric effect of bexagliflozin may contribute to
urinary tract infection. Standard cystitis/urinary tract infection therapy should be
initiated.
Severe dehydration should lead to screening for DKA. Appropriate supportive fluid
therapy should be given as needed. Due to the mode of action of bexagliflozin, DKA
can occur in the absence of hyperglycaemia (euglycemic DKA). See also sections
3.3 and 3.5.
May occur as part of the underlying disease or due to the effect of bexagliflozin
treatment. Persistent weight loss should lead to screening for DKA. Due to the mode
of action of bexagliflozin, DKA can occur in the absence of hyperglycaemia
(euglycaemic DKA). See also sections 3.3 and 3.5.
Increasing or persistently elevated feline pancreatic lipase or liver parameters
should prompt further evaluation for pancreatitis and/or hepatic disease. Consider
treatment discontinuation.
May be euglycaemic. In case of DKA, stop treatment and initiate insulin therapy.
See also sections 3.3 and 3.5.
Resolves without additional treatment. May occur as part of the underlying disease
or due to the osmotic effect of bexagliflozin.
Normally mild and does not need specific therapy.
Normally mild, with calcium levels staying close to the reference range, and does
not need specific therapy. If persistent hypercalcaemia develops, cats are at
increased risk of forming calcium containing uroliths; in this case, bexagliflozin
treatment should be withdrawn.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian,
to either the marketing authorisation holder or the national competent authority via
the national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during
pregnancy, lactation or for breeding cats. Use of the product is therefore not
recommended during pregnancy or lactation or in breeding cats.
3.8 Interaction with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
For oral use.
Give one flavoured tablet daily to cats at approximately the same time each day, with
or without food, and regardless of blood glucose levels.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
After administration of the veterinary medicinal product up to 5 times the
recommended dose for 26 weeks to young healthy cats, polyuria, glucosuria,
increased urine glucose creatinine ratio, loose faeces and increased food
consumption were observed.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable.
4.