Senvelgo 15 mg/ml oral solution for cats – Correct use of product in cats with diabetes

19/07/2024
Medicines for animal use Caution-in-use notification (CIUN)

Not all diabetic cats may be suitable for treatment with Senvelgo®, especially those currently being managed with insulin. Careful patient selection is important. Serious consequences (including diabetic ketoacidosis (DKA) and fatalities) have been reported from post‐marketing pharmacovigilance data, including cases where unsuitable cats were switched from insulin therapy to Senvelgo®.

Problem or issue

Senvelgo is indicated for the reduction of hyperglycaemia in cats with non-insulin-dependent diabetes mellitus.


Correct use of the product is required to minimise serious consequences (including diabetic ketoacidosis (DKA) and fatalities) which have been reported from post-marketing pharmacovigilance data.


Not all diabetic cats may be suitable for treatment with Senvelgo, especially those currently being managed with insulin. Careful patient selection is important.


Most of these DKA cases occurred between 0-4 days after starting treatment. This highlights the importance of checking for ketones after initiating treatment, daily for 

the first 7 days and then every 1-3 days for the following week. In addition, screening for the presence of ketone bodies should ideally also be performed on plasma within this first 2-week period.


Prior to initiating treatment with Senvelgo, screening for DKA must be performed as DKA is a potentially fatal metabolic complication of diabetes mellitus.


Insulin pre-treated diabetic cats are at higher risk of developing DKA and ketonuria, compared to newly diagnosed patients.

Background Information Or Related Documents

Senvelgo is a centrally authorised veterinary medicine. On 19 July 2024, the European Medicines Agency (EMA) published a notice, known as a direct healthcare professional communication, in order to alert veterinary practitioners about important information for prescribing, dispensing or administered the product.  It is available from EMA’s website (link here).

Product information

Active substance
Velagliflozin L-proline monohydrate
Authorisation holder
Boehringer Ingelheim Vetmedica GmbH
Authorisation number

EU/2/23/305/001-002, Senvelgo 15 mg/ml oral solution for cats.

 

Human or veterinary medicine
Veterinary medicine 
Target audience
Veterinarians; Animal owners

Actions to be taken

Veterinarians should read and follow the Summary of Product Characteristics available from the Union Product Database [UPD] (link here).

Veterinarians should inform cat owners of the risk of DKA and seek to ensure that cat owners are able to carefully monitor their cats for potential development of DKA; immediate veterinary consultation is necessary if ketones are detected or clinical signs of DKA are observed.

For the first two weeks of treatment, it is important to closely monitor cats for potential development of DKA and whenever the cat shows clinical signs of illness whilst being treated.

Immediate discontinuation of treatment in the event of confirmed or suspected DKA or diabetic ketonuria, appropriate investigation, and immediate initiation of appropriate therapy (e.g. insulin therapy) is required. Cat owners should be advised to contact their veterinarian in this respect.

DKA, under SGLT-2 inhibition, may occur with normal blood glucose concentrations (euglycaemic ketoacidosis). However, the immediate initiation of insulin treatment is still needed to stop the progression of ketoacidosis.

Report any adverse events to Boehringer Ingelheim Vetmedica GmbH or to the HPRA.

Further Information:

Further information may be obtained from the European Medicines Agency.