Veterinary Medicines Directorate
For the attention of veterinarians and cat owners
The VMD has received a number of suspected adverse event reports concerning diabetic ketoacidosis (DKA) following administration of Senvelgo 15 mg/ml oral solution for cats, a veterinary medicinal product (VMP) indicated for the treatment of diabetes mellitus in cats.
Adverse event reports received may include reports where more than one product was used, the product was used off-label and/or, where, on further evaluation, it is considered that there is no causal association between the product and event.
We wish to raise awareness about the correct use of this product as described in the product Summary of Product Characteristics (SPC) to minimise the known risk of adverse events occurring after its administration:
- Appropriate patient selection: Do not use in cats with evidence of diabetic ketoacidosis, diabetic ketonuria, or severe dehydration. Prior to initiating treatment, screening for ketoacidosis should be performed and treatment should not be initiated whilst urine ketone bodies are detected.
- Please, be aware that insulin pre-treated cats may be at higher risk for DKA compared to newly diagnosed cats.
- 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.
- Cats should be routinely monitored including urinalysis (ketonuria, urinary tract infection (UTI)), hydration status and body weight.
- Discontinue treatment immediately in the event of confirmed or suspected DKA or diabetic ketonuria.
- Owners should be informed of the risk of DKA and they should be able to monitor their cats for potential development of DKA.
- When submitting adverse events, we strongly encourage reporters to include as much information as possible regarding previous treatment with other insulin products and clinical tests performed prior to initiating Senvelgo treatment.
Guidance for correct use of the product and appropriate patient selection can be found in the product SPC and should be adhered to.
We will continue to monitor reports for this product and are working alongside the Marketing Authorisation Holder, Boehringer Ingelheim.
You will find the Summary of Product Characteristics (SPC) for all veterinary medicinal product authorised for marketing in the UK on ourProduct Information Database
No medicine is 100% risk free, the SPC includes information on contraindications, special warnings and special precautions for use as well as what adverse events have been known to occur following administration of a particular product.
All safety updates to SPCs other than template changes, are published on the Veterinary Practice and Supply page under the Medicine Updates section ofVMD Connect.
Reporting of adverse events
We strongly encourage anyone who is aware of an adverse event to report to the Marketing Authorisation Holder or directly to us via our online reporting form Report a suspected problem with an animal medicine or microchip: Overview - GOV.UK.
Contact details for the Marketing Authorisation Holder can be on the product leaflet or on the Product Information Database Product Information Database.
The reporting of adverse events is critical to our ongoing monitoring activities in order to protect animal health, public health, and the environment. Find out more about pharmacovigilance at VMD Connect Adverse Events and Pharmacovigilance.
About the product
Senvelgo 15 mg/ml oral solution for cats contains velagliflozin which is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor used in the treatment of