Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Guidehouse Germany GmbH, Albrechtstr. 10c, 10117 Berlin, Germany
Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥27 kg/m², who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Therapy with Zynquista should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus.
The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day. After at least three months, if additional glycaemic control is needed, in patients tolerating sotagliflozin 200 mg, the dose may be increased to 400 mg once daily.
Before initiating treatment with sotagliflozin 200 mg and before increasing dose to sotagliflozin 400 mg:
Sotagliflozin must only be administered as an adjunct to insulin. In order to avoid hypoglycaemia with the first dose of sotagliflozin a 20% reduction in the first mealtime bolus insulin may be considered. Subsequent bolus doses should be adjusted individually based on blood glucose results. No reduction in basal insulin is recommended when initiating sotagliflozin. Subsequently, basal insulin should be adjusted based on blood glucose results. When needed, insulin dose reduction should be done cautiously to avoid ketosis and DKA.
During the initial one to two weeks of treatment with sotagliflozin, ketones should be monitored on a regular basis. After starting therapy, the frequency of ketone level testing (either blood or urine) should be individualized, according to the patient’s lifestyle and/or risk factors (see section 4.4). Patients should be informed about what actions to take if ketone levels are elevated. The recommended actions are listed in Table 1. Measurement of blood ketone levels is preferred over urine.
Table 1. Actions to take in case of elevated ketone levels:
| Clinical stage | Blood Ketone (betahydroxybutyrate) | Urine Ketone | Actions |
|---|---|---|---|
| Ketonaemia or Ketonuria | 0.6-1.5 mmol/L | Trace or Small + | The patient may need to take extra rapid-acting insulin and drink water. Extra carbohydrates should be taken if the glucose levels are normal or low. Ketone levels should be measured again after two hours. Check glucose levels frequently to avoid hyperglycaemia or hypoglycaemia. The patient should immediately seek medical advice and stop taking sotagliflozin if levels persist and symptoms present. |
| Impending DKA | >1.5-3.0 mmol/L | Moderate ++ | The patient should immediately seek medical advice and stop taking sotagliflozin. The patient may need to take extra rapid acting insulin and drink water. Extra carbohydrates should be taken if the glucose levels are normal or low. Ketone levels should be measured again after two hours. Check glucose levels frequently to avoid hyperglycaemia or hypoglycaemia. |
| Probable DKA | >3.0 mmol/L | Large to very large +++ / ++++ | The patient should go to emergency department without delay and stop taking sotagliflozin. The patient may need to take extra rapid-acting insulin and drink water. Extra carbohydrates should be taken if the glucose levels are normal or low. |
If a dose is missed, it should be taken as soon as the patient remembers the missed dose. A double dose should not be taken on the same day.
No dosage adjustment is recommended based on age.
In patients 65 years and older, renal function and an increased risk for volume depletion should be taken into account (see sections 4.4 and 4.8). Due to the limited therapeutic experience in patients aged 75 years and older, initiation of sotagliflozin therapy is not recommended.
Assessment of renal function is recommended prior to initiation of sotagliflozin and periodically thereafter (see section 4.4).
Initiation of sotagliflozin is not recommended when eGFR is less than 60 ml/min/1.73 m² and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m² (see sections 4.4 and 4.8).
Sotagliflozin should not be used in patients with severe renal impairment, end stage renal disease (ESRD) or in patients on dialysis as it has not been studied in these patients (see sections 4.4 and 5.2).
No dose adjustment is recommended in patients with mild hepatic impairment. Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment (see sections 4.4 and 5.2).
The safety and efficacy of sotagliflozin in children and adolescents has not yet been established. No data are available.
Oral use.
Sotagliflozin should be taken once daily before the first meal of the day.
Multiple doses of 800 mg once daily were administrated in healthy volunteers and these doses were well tolerated.
In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient’s clinical status.
The removal of sotagliflozin by haemodialysis has not been studied.
30 months.
This medicinal product does not require any special storage conditions.
PVC/PCTFE/Aluminium opaque blisters.
Pack sizes of 10, 20, 30, 60, 90, 100, 180 film-coated tablets, and a multipack of 200 film-coated tablets (2 packs of 100 film-coated tablets).
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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