Contraindications
Do not use in horses with anorexia.
Do not use in horses with hyperlipaemia and associated clinical signs such as inappetence or lethargy.
Special warnings
Laminitis is a common clinical sign of insulin dysregulation (ID).
Therefore, suitable endocrinologic tests should be conducted and clinical signs assessed to establish a diagnosis of insulin dysregulation (ID) prior to treatment. Insulin concentrations of horses may also be influenced by seasonal variation. The effect of velagliflozin treatment may vary depending on the husbandry practices employed, particularly in the context of a diet high in non-structural carbohydrates. Velagliflozin treatment cannot replace appropriate husbandry management of an ID horse, which includes dedicated diet and regular exercise, as feasible
Special precautions for use Special precautions for safe use in the target species:
In response to administration of velagliflozin and the resulting metabolic changes, an increase of triglycerides (TGs) in the blood (hypertriglyceridaemia) may occur. This hypertriglyceridaemia is usually asymptomatic and transient.
Triglyceride concentrations above reference ranges may be observed as part of the underlying metabolic profile in insulin-dysregulated horses. Measurement of triglyceride concentrations prior to initiation of treatment can provide a reference for the individual horse. Triglyceride concentrations should be monitored following treatment initiation (e.g., after 4 to 14 days) as horses might develop transient hypertriglyceridaemia within the first weeks of treatment. In the event the increase of TGs is found to be clinically significant in an individual horse, appropriate follow-up monitoring is indicated.
In horses with hypertriglyceridaemia which do not show clinical signs of hyperlipaemia (such as inappetence or lethargy), the treatment can be continued based on a benefit-risk assessment by the attending veterinarian.
If significant hypertriglyceridaemia persists, continuation of treatment should be revisited based on a benefit-risk assessment by the attending veterinarian, also taking into account the potential presence of co-morbidities predisposing to increased TG concentration, e.g. hepatic lipidosis.
In case clinical signs of hyperlipaemia are observed, treatment should be paused until those signs are resolved. Treatment can be resumed as per assessment of the attending veterinarian.
If hypoglycaemia is suspected or confirmed, treatment should only be started after resolution.
Nutritional strategies for diet optimisation in line with guideline recommendations for management of ID should have been implemented prior to starting treatment with velagliflozin. The start of velagliflozin treatment should not coincide with abrupt feed restrictions in the context of dietary interventions or coincide with significantly reduced feed intake.
Due to the glucosuric effect of velagliflozin causing osmotic diuresis and potential volume depletion, constant free access to water for drinking must be ensured.
In clinical studies, velagliflozin at a dose of 0.3 mg/kg was given to 11 horses for 40 weeks. The safety and efficacy of the product has not been assessed for administration beyond this duration.
In pre-clinical and clinical studies, biochemical parameters, including insulin, returned to pre-treatment levels within 4 weeks following withdrawal of treatment. In one of these studies, without husbandry changes, elevated digital pulses were also observed in four out of six horses during the post-treatment period. One of these horses subsequently developed laminitis.
The duration and need for ongoing treatment should be determined on a case-by case basis by the responsible veterinarian.
The safety and the efficacy of the veterinary medicinal product have not been investigated in horses under 3 years of age, nor in horses under 110 kg in bodyweight.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Accidental exposure to the product may cause increased urination, and symptoms of low blood pressure or low blood sugar, such as dizziness. Take care to avoid children accessing an unattended filled syringe. Do not leave the syringe unattended. If skin contact occurs, avoid hand-to-mouth contact, and wash hands immediately. If symptoms occur, seek medical advice. The product may cause slight irritation to the eyes. Avoid contact with the eyes. If contact with the eyes occurs, rinse immediately with water, and seek medical advice if symptoms persist.
The product contains propylene glycol, which may cause hypersensitivity reactions. People with known hypersensitivity to this substance should avoid contact with the product. As no data are available to conclude whether exposure to velagliflozin presents a risk to pregnant and/or breastfeeding women, they should consider wearing gloves in addition to standard hygiene practices.
Adverse events
Horses:
Very common (>1 animal / 10 animals treated): | Elevated triglyceride1 |
Common (1 to 10 animals / 100 animals treated): | Weight loss2 |
Undetermined frequency (cannot be estimated from available data) | Polyuria3, polydipsia4 |
1 Severe hypertriglyceridaemia (> 5.7 mmol/L) is usually asymptomatic and transient (for monitoring recommendations see section ‘Special precautions for use’ above).
2 Weight loss may occur due to the glucosuric effect and the associated calorie loss and may be excessive. Undesirable weight loss can be mitigated by an appropriate diet plan in parallel to treatment.
3 Polyuria may occur due to the osmotic diuretic effect of velagliflozin-induced glucosuria.
4 Polydipsia may occur as compensation for polyuria (osmotic diuretic effect of velagliflozin-induced glucosuria).
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during pregnancy or lactation. The use is not recommended during pregnancy or lactation. Use only according to the benefit-risk assessment by the attending veterinarian.
Fertility:
The use is not recommended in breeding animals, as the safety of the veterinary medicinal product has not been established in the context of breeding.
Interaction with other medicinal products and other forms of interaction
Direct drug-drug interactions have not been investigated in vivo. The potential of drug-drug interactions is considered negligible for velagliflozin.
The concomitant use of pergolide and NSAIDs in horses receiving velagliflozin treatment has been investigated and did not impact the safety or efficacy of the veterinary medicinal product.
Limited data are available for concomitant use of metformin and levothyroxine in horses under velagliflozin treatment. The concomitant use of the veterinary medicinal product with other potentially blood insulin lowering pharmaceutical compounds has not been investigated.
Concomitant treatment with diuretics has not been evaluated. Due to the pharmacodynamic effect, which induces osmotic diuresis
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
None observed at a once daily dose of 1 mg/kg bodyweight (corresponds to 3.3-fold the recommended dose) following administration for 16-weeks.
Withdrawal periods
Not to be used in horses intended for human consumption. Treated horses may never be slaughtered for human consumption. The horse must have been declared as not intended for human consumption under national horse passport legislation.