Senvelgo 15 mg/ml solution for oral administration for cats
Summary
The veterinary medicinal product "Senvelgo 15 mg/ml oral solution for cats" was first authorized in the European Union (EU) in November 2023. It contains velagliflozin, a sodium-dependent glucose cotransporter-2 (SGLT-2) inhibitor which is a new active substance in veterinary medicine.
Since the launch of Senvelgo, serious adverse reactions (including diabetic ketoacidosis (DKA) and deaths) have been reported through the European Pharmacovigilance Network, including cases where unsuitable cats were switched from insulin therapy to Senvelgo.
The marketing authorization holder is therefore providing information on the correct use of the veterinary medicinal product in a communication coordinated with the European Medicines Agency (EMA) and the competent EU authorities to prevent possible risks associated with the development of diabetic ketoacidosis.
Background information
Senvelgo is indicated to reduce hyperglycemia in cats with non-insulin-dependent diabetes mellitus. An SGLT-2 inhibitor works differently to insulin and reduces blood glucose by preventing renal glucose reabsorption. For this reason, it is only suitable for cats that are still able to produce sufficient amounts of endogenous insulin. Therefore, the use of SGLT-2 inhibitors is not recommended for all diabetic cats.
Before starting treatment with Senvelgo, the cat must be examined for diabetic ketoacidosis, as DKA is a potentially fatal metabolic complication of diabetes mellitus. Diabetic cats pre-treated with insulin are at higher risk to develop DKA and ketonuria compared to newly diagnosed patients.
Most of the reported DKA cases occurred 0-4 days after starting treatment. Therefore, the occurrence of ketone bodies should be monitored accordingly after initiating treatment.
If ketone bodies or clinical signs of DKA are detected, such as sudden weight loss, dehydration, lethargy, anorexia (inappetence), vomiting or cachexia, a veterinarian should be consulted immediately. In case of confirmed or suspected DKA or diabetic ketonuria, immediate discontinuation of treatment and initiation of appropriate therapy is required.
The relevant information on patient selection and correct monitoring during treatment can also be found in the Summary of Product Characteristics.
Currently, the positive benefit-risk ratio for Senvelgo remains unchanged without any changes to the product information (e.g. Summary of Product Characteristics, Package Leaflet).
Please report any adverse reactions associated with the use of Senvelgo to the Federal Office for Safety in Health Care.
Further information:
- Information letter from the marketing authorization holder Boehringer Ingelheim Vetmedica GmbH
- Publication of the EMA
- Register of proprietary medicinal products
- Notification form side effects
