INVOKANA Film-coated tablet Ref.[6483] Active ingredients: Canagliflozin

Posology

The recommended starting dose of canagliflozin is 100 mg once daily. In patients tolerating canagliflozin 100 mg once daily who have an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² or CrCl ≥60 mL/min and need tighter glycaemic control, the dose can be increased to 300 mg once daily orally (see below and section 4.4).

Care should be taken when increasing the dose in patients ≥75 years of age, patients with known cardiovascular disease, or other patients for whom the initial canagliflozin-induced diuresis poses a risk (see section 4.4). In patients with evidence of volume depletion, correcting this condition prior to initiation of canagliflozin is recommended (see section 4.4).

When canagliflozin is used as add-on therapy with insulin or an insulin secretagogue (e.g., sulphonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).

Special populations

Elderly (≥65 years old)

Renal function and risk of volume depletion should be taken into account (see section 4.4).

Renal impairment

For treatment of diabetic kidney disease as add on to standard of care (eg ACE-inhibitors or ARBs), a dose of 100 mg canagliflozin once daily should be used (see table 1). Because the glycaemic lowering efficacy of canagliflozin 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 refer to table 1.

Table 1. Dose adjustment recommendations^a:

^a See sections 4.4, 4.8, 5.1, and 5.2.
^b If further glycaemic control is needed, the addition of other anti hyperglycaemic agents should be considered
^c With urinary albumin/creatinine ratio ˃300 mg/g
^d Continue dosing until dialysis or renal transplantation.

Hepatic impairment

For patients with mild or moderate hepatic impairment, no dose adjustment is required.

Canagliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients (see section 5.2).

Paediatric population

The safety and efficacy of canagliflozin in children under 18 years of age have not yet been established. No data are available.

Method of administration

For oral use.

Invokana should be taken orally once a day, preferably before the first meal of the day. Tablets should be swallowed whole.

If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.

Single doses up to 1,600 mg of canagliflozin in healthy subjects and canagliflozin 300 mg twice daily for 12 weeks in patients with type 2 diabetes were generally well-tolerated.

Therapy

In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute clinical measures if required. Canagliflozin was negligibly removed during a 4-hour haemodialysis session. Canagliflozin is not expected to be dialysable by peritoneal dialysis.

3 years.

This medicinal product does not require any special storage conditions.

Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.

Pack sizes of 10 × 1, 30 × 1, 90 × 1, and 100 × 1 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.