Zynquista

Therapy with Zynquista should be initiated and supervised by a physician experienced in the management of type 1 diabetes mellitus. Posology 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: - Risk factors for diabetic ketoacidosis (DKA) should be assessed and ketone levels should be evaluated as normal. 4). Medicinal Product no longer authorised 3 - Patients must be able to perform self-management of the day-to-day aspects of their disease including self-monitoring of glucose and ketones.

4). 4). 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.

Ketone monitoring during treatment:

During the initial one to two weeks of treatment with sotagliflozin, ketones should be monitored on a regular basis. 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. 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.

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.

Summary of the safety profile The most frequently reported adverse reactions were genital mycotic infections, diabetic ketoacidosis and diarrhoea. Tabulated list of adverse reactions The following adverse reactions have been identified in the pool of two 52-week placebo-controlled clinical trials described above.

Adverse reactions listed below are classified according to frequency and system organ class (SOC). 4 † See subsections below for additional information. a Adverse event grouping, including, but not limited to, vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, genital infection fungal, vulvovaginitis, urogenital infection fungal.

b Adverse event grouping, including, but not limited to, balanoposthitis, genital infections fungal, balanitis candida, epididymitis. c Adverse events grouping, including dehydration, hypovolaemia, postural dizziness, orthostatic hypotension, hypotension, syncope and presyncope when reported in context of volume depletion.

7%. 6 mmol/l. 2%). 21 subjects per 100 patient-years for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo. Fifteen of the 35 cases (43%) experienced DKA with glucose values in the glycaemic range 8 to 14 mmol/L. Medicinal Product no longer authorised 11 Volume depletion Sotagliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion.

0% of patients treated with sotagliflozin 200mg, sotagliflozin 400 mg and placebo. 4). g. 7%). Most of the events were mild or moderate and no serious case was reported. 8% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.

g. 1%). All events were mild or moderate in intensity and no serious cases. 4% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively. 1% for placebo. 8% for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.

Diabetic ketoacidosis Sodium-glucose co-transporter 2 (SGLT2) inhibitors should be used with caution in patients with increased risk of DKA. 8). Before initiating sotagliflozin Before starting treatment, patients should be evaluated with respect to DKA risk.

Sotagliflozin should not be initiated when patients are at a higher risk of DKA, such as: - Patients with low insulin needs. - Patient not on optimal insulin dose or who have recent issues with noncompliance or recurrent errors with insulin dosing and who are unlikely to maintain adequate insulin dosing.

1 episode in the past 3 months or more than 1 episode in the past 6 months). - Patients with increased insulin requirements due to acute medical illness or surgery. 6 mmol/L or urine ketones one plus (+)). 2). - Patients unable or unwilling to monitor ketones.

g. in order to remain in a lipolytic state). - Patients with excessive alcohol consumption or who use illicit drugs. ) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure. Patients should consider monitoring ketones levels three to four hours after changing pump materials.

Patients using a pump should also check their ketone levels with any suspected insulin interruption, regardless of blood glucose levels. Insulin injections should be given within 2 hours of an unexplained high blood glucose value and sotagliflozin treatment should be interrupted.

2). Sotagliflozin should only be given to patients: - with access to ketone testing materials and immediate access to a clinician if blood or urine ketones are elevated. - who are able to monitor ketone levels and are educated in when it is most appropriate to do so.

During a dedicated counselling session with the patient at the time of first prescription of sotagliflozin the Patient/Carer Guide and Patient Alert card, also available via the QRcode or website, should be presented. The Patient Alert Card is also provided in the product packaging.

Medicinal Product no longer authorised 5