Senvelgo

1 x 30 ml

Oral solution

Active substance

Velagliflozin : 15 mg/ml

ATC code

QA10BK90 Velagliflozin

QA10BK Sodium-Glucose Co-Transporter 2 (Sglt2) Inhibitors

QA10B Blood glucose lowering drugs, excl. insulins

QA10 Drugs used in diabetes

QA Alimentary tract and metabolism

Species

Cats.

Indications

For the treatment of diabetes mellitus in cats.

Dose to be administered and administration route

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.

Adverse reactions

Cats.

Very common

(>1 animal / 10 animals treated):

Diarrhoea or loose stool¹

Polydipsia or polyuria²

Weight loss³

Dehydration⁴

Common

(1 to 10 animals / 100 animals treated):

Diabetic ketoacidosis (DKA)⁵

Diabetic ketonuria⁶

Urinary tract infection (UTI)⁷

Hypersalivation⁸

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.

² 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.

³ Weight loss may occur as part of the underlying disease. An initial weight loss may occur due to the glucosuric effect of velagliflozin.

⁴ Mild dehydration.

⁵ Diabetic ketoacidosis (DKA) may be euglycaemic. Stop treatment and initiate insulin therapy. See also sections 3.3 and 3.5.

⁶ Diabetic ketonuria: stop treatment, undertake further investigations and manage accordingly (e.g., initiate insulin therapy). See also sections 3.3 and 3.5.

⁷ 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.

⁸ 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.