The Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA), having analysed recent reports on diabetic ketoacidosis associated with Senvelgo use, now issues recommendations.
Senvelgo 15mg/ml oral solution for cats is a veterinary medicine containing the active substance velagliflozin, an SGLT-2 inhibitor. It is indicated for cats suffering from non-insulin-dependent diabetes mellitus, to lower their high blood sugar levels.
This implies that not all diabetic cats are eligible for treatment with Senvelgo. Hence it is important to carefully select which cats receive the medicine. In particular, cats with a history of insulin treatment were found to run a greater risk of developing diabetic ketoacidosis (DKA) and ketonuria (high levels of ketones in urine) after starting Senvelgo treatment.
In Belgium, 28 cases of adverse reactions were reported associated to Senvelgo use. In four cases the animal was euthanised and in ten cases, ketosis, ketonuria or ketoacidosis was diagnosed, although for these cases, further research is required to determine a direct cause-and-effect relationship with the use of the product.
Recommendations for veterinarians
Based on the reports, where DKA usually occurred within four days of starting treatment, daily screenings for the presence of ketones during the first week of treatment, and subsequent screenings every one to three days during the following week, are required. Moreover, a plasma analysis for detecting ketones should be performed within the first fortnight.
Prior to starting treatment with Senvelgo, DKA screening is mandatory, because DKA is a potentially fatal, metabolic complication of diabetes mellitus.
Veterinarians should inform cat owners about the risk of DKA and ensure that these owners are capable of carefully monitoring their cat for the potential development of DKA.
Immediate discontinuation of Senvelgo treatment in the event of confirmed or suspected DKA or diabetic ketonuria, is required. Appropriate investigation, and immediate initiation of appropriate therapy (e.g. insulin therapy to stop ketoacidosis from progressing in (euglycemic) DKA), are required.
Please consult the direct communication to veterinary health professionals (Direct animal Healthcare Professional Communication, DaHPC) for additional information on this topic.
The FAMHP asks to report any suspected adverse reaction or unexpected side effect via https://www.notifieruneffetindesirable-animaux.be (FR) / www.eenbijwerkingmelden-dieren.be (NL) or directly to the marketing authorisation holder.
Recommendations for owners of treated cats
Your veterinarian will tell you how to recognise and monitor diabetic ketoacidosis (DKA) in your pet. You should consult your veterinarian immediately when ketones are detected or if clinical signs of DKA are observed. Symptoms include weight loss, dehydration, lethargy, loss of appetite, vomiting, muscle breakdown with significant weight loss or ketone detection in the cat's urine (e.g. using urine test strips).