CONSIDERATIONS BEFORE INITIATING TREATMENT OF TYPE 2 DIABETES MELLITUS WITH JARDIANCE¹

• The patient must be assessed for hydration and renal function;
• Treatment must not be started;
  • if the patient is acidotic;
  • if the patient is volume-depleted;
  • in patients with eGFR < ml / min/1,73 m2 or creatinine clearance is < 60 ml / min;
  • in elderly patients aged 85 or older.

DOSAGE RECOMMENDATION FOR JARDIANCE® (EMPAGLIFLOZIN)

Jardiance® is a convenient once daily tablet which can be taken at any time of the day and with or without food¹.

The recommended starting dose, for the treatment of type 2 diabetes, is Jardiance® 10 mg once-daily. This can be increased to Jardiance® 25 mg once-daily if additional glycaemic control is required¹.

When a patient misses a dose of Jardiance®, it should be taken as soon as possible after the missed dose time. The patient must not have taken a double dose on the same day ¹.

DOSAGE OF JARDIANCE® IN PATIENTS TAKING CONCOMITANT MEDICATION¹

Jardiance® can be used alone or in combination with other common therapies¹.

For patients on insulin or insulin secretagogue (e.g. sulphonylurea), a lower dose of these agents may be needed to reduce the risk of hypoglycaemia when used in combination with Jardiance®¹.

There are no clinically meaningful drug-drug interactions which were observed when Jardiance® was co-administered with other commonly used medications ¹.

Jardiance® did not effect the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, digoxin, ramipril, simvastatin, hydrochlorothiazide, torasemide and oral contraceptives when co-administered in healthy volunteers ¹.

DOSAGE CONSIDERATIONS IN SPECIFIC PATIENT GROUPS¹

Renal Insufficiency	Patients with mild renal insufficiency with eGFR ≥ 60 to < 90 mL / min / 1,73 m2	Dose does not need to be adjusted Renal function to be assessed before treatment started and at least 6 monthly thereafter
	Patients with moderate to severe renal insufficiency with eGFR < 60 mL / min / 1,73 m2	Jardiance® not recommended
Hepatic Insufficiency	Dose adjustment may be necessary for patients with severe hepatic impairment
Elderly Patients	When creatinine clearance is ≥ 60 mL / min, no dose adjustment is required
Paediatric Patients	The safety and efficacy of Jardiance® in patients under 18 years of age have not been established

JARDIANCE® INDICATIONS¹

Jardiance® tablets are indicated for adults with type 2 diabetes mellitus:

• As an adjunct to diet and exercise to improve glycaemic control in adults¹,
• In combination with glucose-lowering medicines, including metformin, athiazolidinedione, a Sulphonylurea, a DPP4 inhibitor, or insulin, when these togetherwith diet and exercise, do not provide adequate glycaemic control¹.