VOKANAMET Film-coated tablet Ref.[6488] Active ingredients: Canagliflozin Metformin Metformin and Canagliflozin

Posology

Adults with normal renal function (estimated glomerular filtration rate [eGFR] ≥90 mL/min/1.73 m²)

The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient’s current regimen, effectiveness, and tolerability, using the recommended daily dose of 100 mg or 300 mg canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.

For patients inadequately controlled on maximal tolerated dose of metformin

For patients not adequately controlled on metformin, the recommended starting dose of Vokanamet should provide canagliflozin dosed at 50 mg twice daily plus the dose of metformin already being taken or the nearest therapeutically appropriate dose. For patients who are tolerating a Vokanamet dose containing canagliflozin 50 mg who need tighter glycaemic control, the dose can be increased to Vokanamet containing 150 mg canagliflozin twice daily (see below and section 4.4).

For patients switching from separate tablets of canagliflozin and metformin

For patients switching from separate tablets of canagliflozin and metformin, Vokanamet should be initiated at the same total daily dose of canagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.

Dose titration with canagliflozin (added to the optimal dose of metformin) should be considered before the patient is switched to Vokanamet.

In patients tolerating Vokanamet containing canagliflozin 50 mg who need tighter glycaemic control, increasing the dose to Vokanamet containing canagliflozin 150 mg may be considered.

Care should be taken when increasing the dose of Vokanamet containing 50 mg of canagliflozin to 150 mg of canagliflozin 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 Vokanamet is recommended (see section 4.4).

When Vokanamet is used as add-on therapy with insulin or an insulin secretagogue (e.g., a 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)

Because metformin is eliminated in part by the kidney and elderly patients are more likely to have decreased renal function, Vokanamet should be used with caution as age increases. Regular assessment of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients. The risk of volume depletion associated with canagliflozin should be taken into account (see sections 4.3 and 4.4).

Renal impairment

Vokanamet is contraindicated in patients with severe renal failure (eGFR <30 mL/min) (see section 4.3).

An eGFR should be assessed before initiation of treatment with metformin containing products and at least annually thereafter. In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.

The maximum daily dose of metformin should preferably be divided into 2-3 daily doses. Risk factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with eGFR <60 mL/min/1.73 m².

If no adequate strength of Vokanamet is available, individual monocomponents should be used instead of the fixed dose combination (see table 1).

Table 1. Dose adjustment recommendations:

Hepatic impairment

Vokanamet is contraindicated in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2). There is no clinical experience with Vokanamet in patients with hepatic impariment.

Paediatric population

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

Method of administration

For oral use.

Vokanamet should be taken orally twice daily with meals to reduce the gastrointestinal undesirable effects associated with metformin. Tablets are to be swallowed whole.

If a dose is missed, it should be taken as soon as the patient remembers unless it is time for the next dose in which case patients should skip the missed dose and take the medicinal product at the next regularly scheduled time.

Canagliflozin

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.

Metformin

Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g; although, lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may lead to lactic acidosis. Lactic acidosis is a medical emergency and must be treated in hospital. The most effective method to remove lactate and metformin is haemodialysis.

Therapy

In the event of an overdose of Vokanamet, 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 as dictated by the patient’s clinical status. The most effective method to remove lactate and metformin is haemodialysis. Canagliflozin was negligibly removed during a 4-hour haemodialysis session. Canagliflozin is not expected to be dialysable by peritoneal dialysis.

3 years.

Do not store above 30°C.

HDPE bottle with child-resistant closure, induction seal, and desiccant.

The bottles contain 20 or 60 film-coated tablets.

Pack sizes:

1 × 20 film-coated tablets

1 × 60 film-coated tablets

Multipack containing 180 (3 × 60) 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.