MDose · Veterinary drug reference
VELAGLIFLOZIN (VELAGLIFLOZIN L-PROLINE MONOHYDRATE)
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Indications1
SENVELGO is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34067-9 (INDICATIONS & USAGE SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Dose regimens1
This calculator performs arithmetic only on the sourced dosing field shown for each result — it does not verify the field's accuracy, does not select which field to use for a patient, and does not replace a veterinarian's order. Not for clinical use. Confirm every result against the primary source before dispensing.
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Adverse effects142
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. The following adverse reactions were seen in the study with < 1% frequency: elevated creatine kinase (> 3X ULN), hypoglycemia without clinical signs (glucose ≤ 50 mg/dL), anemia, abnormal behavior, bradycardia, and dermatitis. Ketonuria and diabetic ketoacidosis: Thirty-two (32) cats developed ketonuria, diabetic ketoacidosis or euglycemic diabetic ketoacidosis and were removed from the study. Twenty-six (26) of these cats developed ketonuria, diabetic ketoacidosis, or euglycemic diabetic ketoacidosis within the first 7 days of treatment with SENVELGO. Thirteen (13) of these cats developed ketonuria without further progression to diabetic ketoacidosis or euglycemic ketoacidosis and transitioned to insulin. An additional thirteen (13) cats developed diabetic ketoacidosis or euglycemic ketoacidosis. Nine cats recovered after hospitalization and intensive treatment. Three of the 9 cats had concurrent conditions: hepatopathy (1), hepatic lipidosis (1), and pancreatitis and hepatic lipidosis (1). Four of the 13 cats were euthanized; three because the owners declined treatment and one cat was euthanized after not responding to hospitalization and intensive treatment. Six cats developed ketonuria, diabetic ketoacidosis or euglycemic diabetic ketoacidosis after the first 7 days of treatment. One cat developed ketonuria without progression to diabetic ketoacidosis or euglycemic ketoacidosis after more than 4 months on SENVELGO. Five cats developed diabetic ketoacidosis or euglycemic ketoacidosis. Two cats (one with concurrent pancreatitis and hepatic lipidosis) were treated and recovered. One with concurrent pancreatitis was treated and recovered but died several days later. Two of the five cats were euthanized; one cat was euthanized after poor response to hospitalization and intensive therapy; and one was euthanized due to declining condition unrelated to diabetic ketoacidosis. Thirty-eight enrolled cats had been previously treated with insulin. Of those 38 cats, 12 (32%) developed ketonuria, diabetic ketoacidosis, or euglycemic diabetic ketoacidosis during the first week and were removed from the study. These 12 cats are included in the 26 cases reported above and represent 46% of the cases removed in the first week of treatment due to ketonuria or ketoacidosis. Death and euthanasia: Nineteen cats died (3) or were euthanized (16) during the study, or shortly following removal from the study, with thirteen possibly related to SENVELGO use or declining glycemic control. In addition to 6 of the cases associated with diabetic ketoacidosis described above, euthanasia was associated with the following conditions (number of cats): acute renal failure within a week of starting SENVELGO (1), worsening or emergent urinary incontinence associated with poor glycemic control (2), worsening polyuria/polydipsia and inappropriate urination (1), progressive signs of diabetes mellitus (1), declining condition and suspected pancreatitis (1), azotemia and lack of effect within a week of starting SENVELGO and possible concurrent hypersomatotropism (1). Adverse Reactions Frequency (N=252) Number (%) Diarrhea (including loose stool) 132 (52.3%) Weight loss* 111 (44%) Vomiting 92 (36.5%) Polyuria 46 (18.3%) Polydipsia 42 (16.7%) BUN† 39 (15.5%) Anorexia or hyporexia 34 (13.5%) Hypersalivation and/or gagging 33 (13.1%) Urine specific gravity > 1.060 29 (11.5%) Dehydration 28 (11.1%) Lethargy 20 (7.9%) Polyphagia 19 (7.5%) Urinary tract infections/cystitis 18 (7.1%) Diabetic ketoacidosis or euglycemic diabetic ketoacidosis‡ 18 (7.1%) Hypercalcemia 16 (6.3%) Ketonuria§ 14 (5.6%) Inappropriate urination 14 (5.6%) Death or euthanasia 13 (5.2%) Elevated AST and/or ALT 12 (4.8%) Hypertriglyceridemia†† 12 (4.8%) Hyperphosphatemia 12 (4.8%) Elevated fPL 11 (4.4%) Pancreatitis 10 (4.0%) Elevated creatinine 9 (3.6%) Hepatic lipidosis 6 (2.4%) Urinary incontinence 3 (1.2%) *Approximately 80 cats had weight loss during the first week of treatment, likely due to dehydration and/or caloric wasting from glucosuria. †Most cats had elevations ≤ 1.5X upper limit of normal (ULN). ‡All but 5 cases occurred within 2 weeks of starting SENVELGO.Twelve of these cats had euglycemic diabetic ketoacidosis. §These cats did not progress to diabetic ketoacidosis and all but one developed ketonuria within a week of starting SENVELGO. The cats discontinued SENVELGO and transitioned to insulin. Four of these cats had AST (aspartate aminotransferase) and/or ALT (alanine … [truncated]
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34084-4 (ADVERSE REACTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
These are counts of spontaneously reported events, not proven adverse effects, causal relationships, or incidence rates.
Bars compare report counts within each species; they do not show incidence.
More reportsFewer reportsDog
- Overdose31 reports
- Diarrhoea20 reports
- Vomiting18 reports
- Hypersalivation10 reports
- Wound5 reports
- Dermal cyst(s)3 reports
- Skin scab3 reports
- Abrasion2 reports
- Blood in faeces NOS2 reports
- Hot spot (pyotraumatic dermatitis)2 reports
- Ocular discharge2 reports
- Reddening of the skin2 reports
Cat
- Ketosis1,543 reports
- Lack of efficacy - NOS1,054 reports
- Weight loss1,007 reports
- Diarrhoea697 reports
- Vomiting617 reports
- Lethargy (see also Central nervous system depression in Neurological)557 reports
- Ketonuria520 reports
- Anorexia402 reports
- Death by euthanasia271 reports
- Elevated blood urea nitrogen (BUN)245 reports
- Hypokalaemia212 reports
- Dehydration197 reports
Contraindications2
WARNING: DIABETIC KETOACIDOSIS/EUGLYCEMIC DIABETIC KETOACIDOSIS - 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) .
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34066-1 (Boxed Warning section) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34070-3 (CONTRAINDICATIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Precautions2
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: 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. • 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 • Bilirubin > 0.5 mg/dL • Creatinine > 2 mg/dL
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34071-1 (WARNINGS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Consider temporarily discontinuing SENVELGO during times of decreased caloric intake, such as surgery or decreased appetite, as continued administration of SENVELGO 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.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 42232-9 (PRECAUTIONS SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Pharmacokinetics1
Mechanism of Action: Velagliflozin is an inhibitor of sodium-glucose cotransporter 2 (SGLT2), the renal transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, velagliflozin reduces the reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion. Pharmacokinetics: max 0-last In a laboratory study conducted to determine the prandial state of maximum exposure,systemic exposure for velagliflozin was greater in the fasted state than in the fed state by170% for the mean maximum observed plasma concentration (C), and by 45% for the mean area under the plasma concentration versus time curve (AUC) from dosing (time 0) to the last quantifiable concentration (AUC), respectively. Target Animal Safety max In a well-controlled, laboratory margin of safety study in healthy, adult cats (see), after repeat daily oral dosing for six months, a slight to moderate increase in exposure to velagliflozin was observed. In addition, a tendency for a less than dose proportionalincrease of maximum plasma concentration (C) and exposure (AUC) over the tested dose range was noted. max 0-last Following oral administration of SENVELGO in cats at 1 mg/kg, velagliflozin was rapidly absorbed with a median time to maximum concentration of 0.25 hours. The velagliflozin mean (± standard deviation) Cwas 1030 (± 361) ng/mL and the mean AUCto the last quantifiable plasma concentration was 3295 (± 1098) day*ng/mL. The elimination half-life of velagliflozin was 3.68 (± 0.34) hours.
Species not recordedOn-label (ON_LABEL)United States1 source record · View provenance
- Species not recorded · SPL section 34090-1 (CLINICAL PHARMACOLOGY SECTION) · United States · On-label (ON_LABEL) · Pending clinical review (PROPOSED) · Rule-based
Literature references6
References are linked to this drug. Species applicability is not recorded here, so the species filter does not narrow this list. Imported dates do not retain their original precision; confirm dates in the original citation.
- Effects of Velagliflozin in 8 Cats With Diabetes Mellitus and Hypersomatotropism.
Study summary not available in the imported record. Open the original citation to review the study.
- Sodium-glucose co-transporter 2 inhibitors: a pleiotropic drug in humans with promising results in cats.
Study summary not available in the imported record. Open the original citation to review the study.
- Velagliflozin, a once-daily, liquid, oral SGLT2 inhibitor, is effective as a stand-alone therapy for feline diabetes mellitus: the SENSATION study.
Study summary not available in the imported record. Open the original citation to review the study.
- Efficacy and safety of once daily oral administration of sodium-glucose cotransporter-2 inhibitor velagliflozin compared with twice daily insulin injection in diabetic cats.
Study summary not available in the imported record. Open the original citation to review the study.
- The efficacy and safety of velagliflozin over 16 weeks as a treatment for insulin dysregulation in ponies.
Study summary not available in the imported record. Open the original citation to review the study.
Sources: DailyMed, U.S. National Library of Medicine; PubMed, National Library of Medicine; openFDA, U.S. Food and Drug Administration.
Available products
Products listed in the Health Canada Drug Product Database for this active ingredient. A listing does not establish that a product is authorized for the clinical uses described on this page.