Senvelgo 15 mg/ml Oral Solution for Cats

cats that had previously not received any treatment for DM developed clinical DKA
whereas 8/66 (12.1%) of cats that had previously been treated with insulin
developed clinical DKA. The likelihood of pancreatic beta-cell loss and insulin-
dependency may be higher in insulin pre-treated cats. As a result, the withdrawal of
the insulin before the start of treatment with the product may lead to a metabolic
destabilisation and initiate ketogenesis. This information should be taken into
account when considering transferring a cat from insulin treatment to treatment with
this veterinary medicinal product.
In line with DM treatment guidelines, cats should also be evaluated for concurrent
disease including pancreatitis, infectious disease, urinary tract infection, neoplasia,
and acromegaly as these conditions may increase the risk of developing
ketoacidosis.
AN: 02946/2025 & 02949/2025
Cats may also require temporary discontinuation of therapy in clinical situations
known to predispose to ketoacidosis (e.g. prolonged fasting due to acute illness,
around surgery).
Cats considered to be at risk of developing diabetic ketoacidosis need close
monitoring after initiation of treatment. The risk of developing diabetic ketoacidosis
significantly decreases after the first two weeks of treatment, but DKA may occur at
any time (see monitoring/precautions below).
Diabetic ketoacidosis (DKA) and ketonuria: Discontinue treatment immediately in the
event of confirmed or suspected DKA or diabetic ketonuria and investigate
accordingly. Due to the mode of action of SGLT-2 inhibitors, DKA may present
without hyperglycaemia (known as euglycaemic DKA). A check for ketone bodies is
therefore required prior to use and/ or whenever DKA is suspected; treatment with
Senvelgo should not be initiated whilst urine ketone bodies are detected.
Diagnosis of euglycaemic DKA can be based on the presence of ketone bodies and
euglycaemia alongside clinical signs such as decreased appetite, acute vomiting,
lethargy and dehydration. The presence of ketone bodies should prompt further
evaluation of the cat; in cases of clinical DKA, it is imperative to initiate treatment in
accordance with standard DKA treatment protocols. This includes the prompt
initiation of insulin therapy, administration of dextrose or other carbohydrate source
as well as appropriate nutritional support. Checking for ketones is required at the
initiation of therapy and every 1-3 days for the first two weeks, as well as whenever
the cat is showing clinical signs of illness.
Delay in diagnosis and treatment of diabetic ketoacidosis and euglycemic diabetic
ketoacidosis may result in increased morbidity and mortality.
The safety and efficacy of the product has not been established in cats younger than
9 months and 4 years, respectively.
The safety and efficacy of the product has not been fully evaluated in severe cases
of renal/liver/cardiac disease. Use only according to the benefit/risk assessment by
the responsible veterinarian.
Remission
Remission of diabetes mellitus in cats is a complex phenomenon, which can be
influenced by multiple factors in individual patients, such as glycaemic control, diet,
age, weight, and/or genetics. Due to velagliflozin’s mode of action it may be difficult
to identify cats which are in remission, since they would not be expected to have
hypoglycaemic events (unlike therapy with insulin). Consideration could be given to
either continuing treatment with velagliflozin indefinitely or withdrawing treatment and
closely monitoring glycaemic control and for return of clinical signs. If the patient
relapses, then velagliflozin treatment can be restarted.
Routine monitoring recommendations
Cats with diabetes mellitus and treated with the veterinary medicinal product should
be routinely monitored according to standard DM treatment guidelines. In addition,
due to the mode of action of velagliflozin, routine monitoring should include urinalysis
(ketonuria, UTI), hydration status (osmotic diuresis) and body weight (unintended
body weight loss due to persistent glucosuria).
AN: 02946/2025 & 02949/2025
Whenever clinical signs of DKA occur the cat should be evaluated for the presence
of ketone bodies (e.g. ketonuria) indicating DKA or comorbidities causing insulin
resistance. If the cat’s clinical condition declines and/or blood glucose or
fructosamine values worsen after initial improvement, additional diagnostics or
alternative therapies may be required. Evaluation of haematology, serum chemistry,
urinalysis and hydration status is recommended.
Due to their mode of action, SGLT-2 inhibitors may cause a mild increase in serum
creatinine, BUN, phosphorus, and sodium within weeks of starting therapy, followed
by a stabilisation of values. Routine evaluation of renal function, body weight and
hydration status in patients with renal disease is recommended.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Accidental exposure to the product may cause increased urination, and symptoms of
low blood pressure or low blood sugar, such as dizziness.
Take care to avoid children accessing an unattended filled syringe.
Do not leave the syringe unattended. Ensure that the food bowl is washed after the
cat has eaten food which was mixed with the product.
If skin contact occurs, avoid hand-to-mouth contact, and wash hands immediately.
If symptoms occur, seek medical advice.
The product may cause slight irritation to the eyes.
Avoid contact with the eyes.
If contact with the eyes occurs, rinse immediately with water, and seek medical
advice if symptoms persist.
The product includes propylene glycol, which may cause hypersensitivity reactions.
People with known hypersensitivity to this substance should avoid contact with the
product.
As no data are available to conclude that exposure to velagliflozin presents a risk to
pregnant and/or breastfeeding women, they should consider wearing gloves in
addition to standard hygiene practices.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Not applicable.
AN: 02946/2025 & 02949/2025
3.6 Adverse events
Cats.
Very common
(>1 animal / 10 animals
treated):
Diarrhoea or loose stool
Polydipsia or polyuria
Weight loss
Dehydration
Common
(1 to 10 animals / 100
animals treated):
Diabetic ketoacidosis (DKA)
Diabetic ketonuria
Urinary tract infection (UTI)
Hypersalivation
1
Around half of cats can be expected to display loose stool/diarrhoea
during treatment. In the majority of incidences loose stool/diarrhoea last
for seven days or less and usually resolve without specific treatment.
About 25% of cats can experience loose stool/diarrhoea lasting longer
than 28 days. In case diarrhoea persists, alternative treatment for
diabetes mellitus should be considered on a case by case basis.
Polydipsia or polyuria resolves without additional treatment; may occur as
part of the underlying disease or may be enhanced due to the osmotic
effect of velagliflozin.
Weight loss may occur as part of the underlying disease. An initial weight
loss may occur due to the glucosuric effect of velagliflozin.
Mild dehydration.
Diabetic ketoacidosis (DKA) may be euglycaemic. Stop treatment and
initiate insulin therapy. See also sections 3.3 and 3.5.
Diabetic ketonuria: stop treatment, undertake further investigations and
manage accordingly (e.g., initiate insulin therapy). See also sections
3.3 and 3.5.
Urinary tract infection including cystitis caused by infection may occur as
part of the underlying disease. The glucosuric effect of velagliflozin may
contribute to urinary tract infection. Standard cystitis/urinary tract infection
therapy should be initiated.
Hypersalivation occurs usually at initial administrations only, occurs
immediately following dosing and resolves quickly, without the need for
treatment.
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
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during
pregnancy and lactation. Use is not recommended during pregnancy and lactation.
AN: 02946/2025 & 02949/2025
3.8 Interaction with other medicinal products and other forms of interaction
Drug-drug interactions have not been investigated in vivo. The potential of drug-drug
interactions is considered negligible as velagliflozin showed a low level of induction
potential for liver microsomal cytochrome P450 (CYP450) enzymes in vitro.
Concomitant treatment with diuretics has not been evaluated. Due to the
pharmacodynamic effect, which may induce mild osmotic diuresis, concomitant
treatment with diuretics may have a potential synergistic effect.
3.9 Administration routes and dosage
Oral use.
The recommended dosing regimen is 1 mg/kg body weight once daily. The dosing
regimen is the same regardless of prior treatment with insulin or another anti-diabetic
medicinal product.
When transitioning from insulin, omit the insulin evening dose the day before starting
velagliflozin treatment.
The solution should be drawn up using the dosing syringe provided in the package.
The syringe fits onto the bottle and has a kg body weight scale, with 0.5 kg
increments. The product may be administered either directly into the mouth or with a
small amount of food, to ensure the entire dose is taken at once.
The medication should be given at approximately the same time every day.
If a dose is missed, it should be given as soon as possible on the same day.
After administration close bottle tightly with the cap. Do not wash the syringe with
water.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
In

[Text truncated]