GLYXAMBI

Posology The recommended starting dose is one film-coated tablet of Glyxambi 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) once daily. In patients who tolerate this starting dose and require additional glycaemic control, the dose can be increased to one film-coated tablet of Glyxambi 25 mg/5 mg (25 mg empagliflozin plus 5 mg linagliptin) once daily.

When Glyxambi is used in combination with metformin, the metformin dose should be continued. 8). Patients switching from empagliflozin (either 10 mg or 25 mg daily dose) and linagliptin (5 mg daily dose) to Glyxambi should receive the same daily dose of empagliflozin and linagliptin in the fixed dose combination as in separate tablets.

Missed doses If a dose is missed, and it is 12 hours or more until the next dose, the dose should be taken as soon as the patient remembers. The next dose should be taken at the usual time. If a dose is missed, and it is less than 12 hours until the next dose, the dose should be skipped and the next dose should be taken at the usual time.

A double dose should not be taken to compensate for a forgotten dose. Special populations Renal impairment The glycaemic efficacy of empagliflozin is dependent on renal function. 73 m2 (see Table 1). Because the glycaemic lowering efficacy of empagliflozin is reduced in patients with moderate renal impairment and likely absent in patients with severe renal impairment, if further glycaemic control is needed, the addition of other anti-hyperglycaemic agents should be considered.

For dose adjustment recommendations according to eGFR or CrCL refer to Table 1. 73 m²] or CrCL [ml/min] Empagliflozin Linagliptin ≥60 Initiate with 10 mg. In patients tolerating 10 mg and requiring additional glycaemic control, the dose can be increased to 25 mg.

b Continue with 10 mg in patients already taking empagliflozin. b Continue with 10 mg in patients already taking empagliflozin. b <30 Empagliflozin is not recommended. 5 mg No dose adjustment for linagliptin is required. 2). Hepatic impairment No dose adjustment is required in patients with mild to moderate hepatic impairment.

2). Therefore, Glyxambi is not recommended for use in this population. Elderly No dose adjustment based on age is required. 8). Paediatric population Safety and efficacy of Glyxambi in paediatric patients below 18 years of age have not been established.

5% with Glyxambi 25 mg empagliflozin/5 mg linagliptin) (see Description of selected adverse reactions). 4). Overall, the safety profile of Glyxambi was in line with the safety profiles of the individual active substances (empagliflozin and linagliptin).

No additional adverse reactions were identified with Glyxambi. Tabulated list of adverse reactions The adverse reactions shown in the table below (see Table 2) are listed by system organ class and are based on the safety profiles of empagliflozin and linagliptin monotherapy.

Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000) and not known (cannot be estimated from the available data).

2% for placebo. In a clinical trial with empagliflozin, haematocrit values returned towards baseline values after a follow-up period of 30 days after treatment stop. 4%. 2% patients treated with linagliptin and in no patients treated with placebo.

7% for placebo). 4%. 5%). There was no notable difference of the incidence in patients treated with different dose strengths of Glyxambi compared to the treatment with empagliflozin or linagliptin. 1%). 4 and information below) Hypoglycaemia with empagliflozin The frequency of hypoglycaemia depended on the background therapy in the respective trials and was similar for empagliflozin and placebo as monotherapy, as add-on to metformin, and as add-on to pioglitazone +/- metformin.

7%, placebo: 58% over the 52-week trial). Major hypoglycaemia with empagliflozin (events requiring assistance) The frequency of patients with major hypoglycaemic events was low (< 1%) and similar for empagliflozin and placebo as monotherapy, as add-on to metformin +/- sulfonylurea, and as add-on to pioglitazone +/- metformin.

Diabetic ketoacidosis Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including empagliflozin. In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).

It is not known if DKA is more likely to occur with higher doses of empagliflozin. The risk of DKA must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.

Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level. In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately. Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.

Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine. Treatment with empagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised.

Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered. Prolonged diabetic ketoacidosis and prolonged glucosuria have been observed with empagliflozin. 2). Empagliflozin-independent factors, such as insulin deficiency, might be involved in prolonged periods of diabetic ketoacidosis.

g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.

1.