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  5. Dear Veterinarian Letter regarding important safety conditions associated with the use of Senvelgo (velagliflozin oral solution) for improving glycemic control in certain cats with diabetes mellitus
  1. Product Safety Information

Dear Veterinarian Letter regarding important safety conditions associated with the use of Senvelgo (velagliflozin oral solution) for improving glycemic control in certain cats with diabetes mellitus

Dear Veterinarian,

We want to inform you of a new product the U.S. Food and Drug Administration (FDA) recently approved, as well as important safety conditions, including those that require emergency intervention, associated with its use. Senvelgo (velagliflozin oral solution) is a new animal drug used to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.

Senvelgo belongs to the class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors. An SGLT2 inhibitor is not insulin and is not for use in cats with insulin-dependent diabetes mellitus. Before using Senvelgo, read the entire product insert, including the boxed warning describing the need for appropriate patient selection and the potential for severe adverse reactions.

Based on data from field studies, the FDA has concluded that Senvelgo may cause an increased risk of diabetic ketoacidosis (DKA) or euglycemic DKA in cats. Euglycemic DKA is a life-threatening emergency that is characterized by euglycemia, metabolic acidosis, and ketoacidosis. Unlike DKA, the diagnosis of euglycemic DKA may be overlooked because of the absence of hyperglycemia.

Senvelgo works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetic cats who have elevated blood glucose levels. The data from a 6-month field study demonstrated that Senvelgo was over 80 percent effective in improving glycemic control in cats with diabetes mellitus. Although there are notable safety concerns with the use of Senvelgo, they can be mitigated by carefully screening cats before starting the drug, continued diligent monitoring regardless of the duration of or response to treatment, and knowing how to promptly recognize and appropriately treat serious and life-threatening adverse reactions. 

The following are summaries of important information from the product labeling:

CONTRAINDICATIONS: Senvelgo should not be used in cats with diabetes mellitus who have previously been treated with insulin, who are receiving insulin, or in cats with insulin-dependent diabetes mellitus. The use of Senvelgo in cats with insulin-dependent diabetes mellitus, or the withdrawal of insulin and initiation of Senvelgo, is associated with an increased risk of diabetic ketoacidosis (DKA) or euglycemic diabetic ketoacidosis (DKA with a normal blood glucose concentration) and death. 

WARNINGS: Senvelgo should not be initiated in cats with anorexia, dehydration, or lethargy at the time of diagnosis of diabetes mellitus or without appropriate screening tests, as detailed in the package insert. Cats treated with Senvelgo may be at an increased risk of diabetic ketoacidosis or euglycemic ketoacidosis. 

As DKA and euglycemic DKA in cats treated with Senvelgo may result in death, development of these conditions should be treated promptly and requires the following actions: 

  • Discontinuation of Senvelgo;
  • Prompt initiation of insulin therapy;
  • Administration of dextrose or other carbohydrate source, regardless of blood glucose concentration; and
  • Appropriate nutritional support should be promptly initiated to prevent or treat hepatic lipidosis.

Delay in recognition and treatment of DKA and euglycemic DKA may result in increased morbidity and mortality. Some cats may exhibit glucosuria and/or euglycemia several days after discontinuation of Senvelgo. 

Cats should be screened for urinary tract infections and treated, if indicated, when initiating Senvelgo. Cats treated with Senvelgo should be monitored for urinary tract infections and treated promptly. 

MONITORING: Sudden onset of hyporexia/anorexia, lethargy, dehydration, or weight loss in cats receiving Senvelgo should prompt immediate discontinuation of Senvelgo and assessment of diabetic ketoacidosis, regardless of blood glucose level. During ongoing treatment with Senvelgo, blood glucose, fructosamine, urinary ketones, serum chemistry, body weight, hydration status, and clinical signs of diabetes mellitus should be routinely monitored. The package insert describes recommendations regarding increasing or persistently elevated triglyceride, cholesterol, or feline specific pancreatic lipase (fPL) levels. 

The package insert describes specific monitoring during the first 4 weeks of Senvelgo therapy. Patients should be evaluated for ketonuria 2 to 3 days after initiation of treatment and approximately 7 days after initiation of treatment, and anytime the cat shows signs of illness. If ketonuria is present, discontinue Senvelgo and promptly treat with insulin, even if the cat’s blood glucose is normal. 

A physical examination, blood glucose curve, serum fructosamine, and body weight should be assessed at 1 and 4 weeks after initiating Senvelgo. Senvelgo should be discontinued, and initiation of insulin considered for cats demonstrating poor glycemic control, including weight loss, an average blood glucose concentration from a blood glucose curve ≥ 300 mg/dL, and/or a fructosamine level indicating poor glycemic control (>450 µmol/L) during the first 4 weeks. 

PRECAUTIONS: Consider temporary discontinuation of Senvelgo in cats during times of decreased caloric intake, such as surgery or decreased appetite, as administration of Senvelgo in these cats may increase the risk of diabetic ketoacidosis. Use caution when giving Senvelgo to cats that are receiving other products containing propylene glycol. Cats receiving Senvelgo at the 1 mg/kg/day dose receive 40 mg/kg/day propylene glycol. Exceeding 80 mg/kg/day of propylene glycol may result in excess hepatic glycogen stores.

INFORMATION FOR CAT OWNERS: Please provide and review the Client Information Sheet with cat owners to ensure they understand the entire contents before Senvelgo is administered. The Client Information Sheet contains important information regarding the use of Senvelgo. Owners should be advised to discontinue Senvelgo and contact a veterinarian immediately if their cat develops anorexia, lethargy, vomiting, diarrhea, or weakness.

The FDA’s Center for Veterinary Medicine (CVM) is committed to promoting and protecting animal health by ensuring safe and effective drugs are available for animals. For more information, please contact CVM’s Education & Outreach Staff at AskCVM@fda.hhs.gov. 

We urge veterinarians and pet owners to report side effects involving Senvelgo to Boehringer Ingelheim Animal Health at 1-888-637-4251. For additional information about reporting adverse drug experiences for animal drugs, contact the FDA at 1-888-FDA-VETS or https://www.fda.gov/reportanimalae.

Sincerely, 

FDA’s Center for Veterinary Medicine 

 
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