L6528 Package Insert
- If clinical signs of illness occur, evaluate the cat as soon as possible to ensure it is not at risk for diabetic ketoacidosis or euglycemic diabetic ketoacidosis (see Animal Safety Warnings ). - SENVELGO should be discontinued if the cat’s clinical condition declines and/or glycemic control worsens after initial improvement. • Cats may present with diabetic ketoacidosis and a normal blood glucose concentration (euglycemic diabetic ketoacidosis). Delay in recognition and treatment of diabetic ketoacidosis and euglycemic diabetic ketoacidosis may result in increased morbidity and mortality. • Development of diabetic ketoacidosis or euglycemic ketoacidosis requires the following actions: - Discontinuation of SENVELGO - Prompt initiation of insulin therapy - Administration of dextrose or other carbohydrate source, regardless of blood glucose concentration - Appropriate nutritional support should be promptly initiated to prevent or treat hepatic lipidosis. Contraindications: Do not use SENVELGO 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 or euglycemic diabetic ketoacidosis and death. Warnings: User Safety Warnings: Not for use in humans. Keep out of reach of children. Wash hands after use. This product may cause mild eye irritation. Avoid contact with eyes. If the product accidentally gets into the eyes, rinse eyes immediately with plenty of water; if wearing contact lenses, rinse the eyes first then remove contact lens(es) and continue to rinse for 5-10 minutes. If eye irritation continues or accidental ingestion occurs, seek medical advice and provide this product information to the physician. Exposure to product may induce local or systemic allergic reaction in sensitized individuals. Oral exposure to velagliflozin may cause transient effects such as increased renal glucose excretion, increased urine volume, and hypoglycemia. Animal Safety Warnings: • SENVELGO should not be initiated in cats with: - Anorexia, dehydration, or lethargy at the time of diagnosis of diabetes mellitus as it may indicate the presence of other concurrent disease and increase the risk of diabetic ketoacidosis. - Ketonuria, ketonemia, or suspected diabetic ketoacidosis or a history of the same - Clinical suspicion of pancreatitis within the last month based on clinical signs, serum fPL > 12 mcg/L, and/or diagnostic imaging consistent with pancreatitis. - Chronic or unresponsive diarrhea - Cachexia
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. WARNING: DIABETIC KETOACIDOSIS/EUGLYCEMIC DIABETIC KETOACIDOSIS 15mg/ mL For oral use in cats only Sodium-glucose cotransporter 2 (SGLT2) inhibitor
- Cats treated with SENVELGO may be at an increased risk of diabetic ketoacidosis or euglycemic ketoacidosis (see Adverse Reactions). As diabetic ketoacidosis and euglycemic ketoacidosis in cats treated with SENVELGO may result in death, development of these conditions should be treated promptly, including insulin administration and discontinuation of SENVELGO (see Monitoring). - Due to the risk of developing diabetic ketoacidosis or euglycemic ketoacidosis, do not use SENVELGO in cats with diabetes mellitus who have previously been treated with insulin, who are receiving insulin, or in cats with insulin-dependent diabetes mellitus (see Contraindications). - 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 (see Animal Safety Warnings). Description: SENVELGO® (velagliflozin oral solution) equal to velagliflozin L-proline H 2 O 20.051 mg/mL, is a clear, colorless to slightly yellow, to slightly brown, liquid multi-dose preparation consisting of 1.5% w/v velagliflozin in an aqueous mixture of propylene glycol and ethanol intended for oral use in cats. SENVELGO is an orally active, sodium-glucose cotransporter 2 (SGLT2) inhibitor. The chemical name of velagliflozin is 2-(4-cyclopropyl-benzyl)-4-((2S,3R,4R,5S,6R)- 3,4,5-trihydroxy-6- hydroxymethyltetrahydropyran-2-yl)-benzonitrile. It forms a co-crystal with L-proline ((S)-pyrrolidine-2-carboxylic acid) as a monohydrate and velagliflozin, L-proline and H2O are in 1:1:1 ratios. Its empirical formula is C 23 H 25 NO 5 x C 5 H 9 NO 2 x H 2 O, its molecular formula is C 28 H 36 N 2 O 8 , and its structural formula is:
- Bilirubin > 0.5 mg/dL - Creatinine > 2 mg/dL
• SENVELGO may cause a mild increase in serum creatinine, blood urea nitrogen (BUN), phosphorus, and sodium in cats with or without chronic kidney disease within weeks of starting therapy, followed by a stabilization of values. • Cats with baseline creatinine between 1.6 and 2 mg/dL when SENVELGO treatment is started should be closely monitored for signs of volume depletion/dehydration and body weight loss. Renal function should be monitored within the first week of treatment initiation and then according to standard chronic kidney disease guidelines. SENVELGO has not been evaluated in cats with baseline creatinine > 2 mg/dL. • 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. • Cats should be evaluated for concurrent disease including pancreatitis, infectious disease, urinary tract infection, neoplasia, and hypersomatotropism (acromegaly) before initiating and while receiving SENVELGO as these conditions may increase the risk of developing diabetic ketoacidosis. • Persistently low or worsening serum chloride values compared to the pre-treatment value may indicate the development of diabetic ketoacidosis or euglycemic diabetic ketoacidosis. • SENVELGO may cause increased serum calcium and persistent elevations may require additional diagnostics. Persistent elevated calcium has been associated with increased risk of calcium-containing urolith formation in other SGLT2 inhibitors. • Cats should be closely monitored for development of diabetic ketoacidosis or euglycemic diabetic ketoacidosis (for example, ketonuria or anorexia) after stopping SENVELGO. Euglycemia may persist for 2 to 3 days after stopping SENVELGO. • Keep SENVELGO in a secure location out of reach of dogs, cats, and other animals to avoid accidental ingestion or overdose. Precautions: • Consider temporarily discontinuing SENVELGO during times of decreased caloric intake, such as surgery or decreased appetite, as continued administration of SENVLEGO may increase the risk of diabetic ketoacidosis. • SENVELGO contains propylene glycol. When cats are administered SENVELGO at the 1 mg/kg/day dose, cats receive 40 mg/kg/day of propylene glycol. Exceeding 80 mg/kg/day of propylene glycol may result in excess hepatic glycogen stores. Use caution when administering SENVELGO to cats receiving other products that contain propylene glycol. • Glucosuria may persist for 2-3 days after stopping SENVELGO. In cats receiving SENVELGO, glucosuria is not a reliable indicator for monitoring glycemic control. • The safety and effectiveness of SENVELGO has not been evaluated in cats with chronic kidney disease (IRIS (International Renal Interest Society) Stages 3 and 4). • The concurrent use of volume depleting drugs in cats treated with SENVELGO has not been evaluated. • SENVELGO has not been evaluated with concurrent use of insulin or other blood glucose lowering treatments. • The safety and effectiveness of SENVELGO in breeding, pregnant, and lactating cats has not been evaluated. Adverse Reactions: Two hundred fifty-two (252) cats with diabetes mellitus were enrolled in a 180-day multicenter field study. Safety data were evaluated in 252 cats treated with at least one dose of SENVELGO. Regardless of blood glucose level, cats received SENVELGO at a dose of 0.45 mg/lb once daily. The most common adverse reactions were diarrhea or loose stool, weight loss, vomiting, polyuria, polydipsia, and elevated blood urea nitrogen (BUN). The table below summarizes the adverse reactions reported in the study.
Indication: SENVELGO is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. Dosage and Administration: Always provide the Client Information Sheet with each prescription. Dosing instructions: The SENVELGO dose is 0.45 mg/lb of body weight (1 mg/kg), once daily regardless of blood glucose level. The dose may be administered directly into the mouth or with a small amount of wet food. Do not mix into food. The solution should be given at approximately the same time every day. If a dose is missed, it should be given as soon as possible on the same day. If the cat vomits within 30 minutes of dosing, the dose can be repeated. SENVELGO should be administered using the dosing syringe provided in the package. The dosing syringe fits onto the bottle and has a body weight scale with increments per pound of body weight. The dose should be rounded down to the nearest pound. After administration, close the bottle tightly with the cap. If needed, the syringe can be
cleaned with a clean, dry cloth. Prior to initiation of treatment:
Prior to initiation of SENVELGO, the veterinarian should ensure the cat is alert, active, eating, and drinking. The veterinarian should conduct a physical examination, obtain a medical history, CBC, serum chemistry, serum fructosamine, and urinalysis including evaluation for ketonuria (see Animal Safety Warnings ). If there is a delay of more than a week between diagnosis of diabetes mellitus and initiation of SENVELGO, the veterinarian should re-evaluate the cat with a full physical examination and updated history to ensure the cat still meets the criteria described above. A delay of more than a week between diagnosis and starting SENVELGO may increase the risk of developing diabetic ketoacidosis. Monitoring of cats receiving SENVELGO: • 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. • Evaluate 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 blood glucose is normal. • During the first 4 weeks after initiation of SENVELGO, glycemic control and clinical improvement should be evaluated. - 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, in cats demonstrating poor glycemic control (weight loss, average blood glucose from a glucose curve > 300 mg/dL or fructosamine values suggesting poor control (> 450 μmol/L) after 4 weeks of treatment. • 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. - Presence of ketonuria should prompt discontinuation of SENVELGO and transition to insulin. - Cats with increasing or persistently elevated triglyceride or cholesterol levels may have declining glycemic control or pancreatitis, and may be at risk of developing diabetic ketoacidosis or euglycemic diabetic ketoacidosis (diabetic ketoacidosis with normal blood glucose levels). Consider further evaluation and discontinuation of SENVELGO in these cats. - Increasing or persistently elevated feline pancreas-specific lipase (fPL) should prompt further evaluation for pancreatitis and consideration of discontinuation of SENVELGO. - Initial mild weight loss may be seen with SENVELGO associated with its mode of action (glucosuria and caloric wasting). Unintentional weight loss which doesn’t improve or stabilize within 7 days may indicate the need to evaluate for concurrent disease and consideration of discontinuation of SENVELGO (see Adverse Reactions ).
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