Invokana - canagliflozin

What is Invokana and what is it used for?

Invokana is an antidiabetic medicine that contains the active substance canagliflozin. It is used in adult patients with type 2 diabetes mellitus to improve the control of the level of glucose (sugar) in the blood. Invokana can be used as the only therapy when diet and exercise alone do not provide adequate control of blood glucose levels in patients who cannot take metformin (another antidiabetic medicine). Invokana can also be used as adjunct therapy in combination with other antidiabetic medicines, including insulin, when these medicines, together with diet and exercise, do not provide adequate control of diabetes.

How is Invokana used - canagliflozin?

Invokana is available as tablets (100 and 300 mg) and can only be obtained with a prescription. The tablets are taken once a day, preferably before the first meal of the day.The recommended starting dose is 100 mg once a day. If appropriate, the dose can be increased to 300 mg once a day. Since the effects of Invokana are dependent on renal function, the efficacy and tolerability of the medicine are reduced in patients with renal insufficiency. Therefore, the use of Invokana is not recommended in patients with severe renal insufficiency. In patients with moderate renal impairment, the dose should be limited to 100 mg once daily. For more information, see the package leaflet.

How does Invokana - canagliflozin work?

Type 2 diabetes is a disease in which the pancreas does not produce enough insulin to control the level of glucose in the blood or in which the body is unable to use insulin effectively, which leads to increased levels blood glucose. The active substance in Invokana, canagliflozin, works by blocking a protein in the kidneys called sodium-glucose type 2 cotransporter (SGLT2). SGLT2 is a protein responsible for the reabsorption of glucose into the bloodstream (bloodstream) from urine, when the blood is filtered into the kidneys. By blocking the action of SGLT2, Invokana induces the elimination of more glucose through the urine and, as a result, it reduces the concentration of glucose in the blood.

What benefit has Invokana - canagliflozin shown during the studies?

Invokana has been studied in 9 main studies involving a total of approximately 10,000 patients with type 2 diabetes. One of the studies compared Invokana, used on its own in patients with blood glucose levels inadequately controlled by diet and exercise, with placebo (a dummy treatment). Three studies looked at the effectiveness of Invokana used as add-on therapy in combination with another diabetes medicine (metformin or insulin), while three other studies looked at the effectiveness of Invokana used as an Add-on therapy in combination with two other antidiabetic medicines (including metformin), in patients whose therapy with these medicines, in addition to diet and exercise, was not sufficient to ensure adequate control of their diabetes. patients with moderate renal insufficiency, while another study involved patients aged 55 to 80 years. In the studies, the main measure of effectiveness was the level in the blood of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. Invokana was more effective than placebo and at least as effective as the comparator medicines in lowering HbA1c levels when used both alone and in combination with other antidiabetic medicines:

  • used alone at the 100 mg dose, Invokana decreased HbA1c levels by 0.91% more than placebo after 26 weeks, while the 300 mg dose resulted in a 1.16% decrease compared to placebo. placebo;
  • in the studies examining the efficacy of Invokana taken in combination with one or two other antidiabetic medicines, the reduction in HbA1c levels after 26 weeks compared to placebo was between 0.76% and 0.92 % more with the 300 mg dose and between 0.62% and 0.74% more with the 100 mg dose;
  • used as an add-on to insulin at the 300 mg dose, Invokana decreased HbA1c levels by 0.73% more than placebo after 18 weeks, while the 100 mg dose resulted in a 0.65% reduction in more than placebo;
  • Invokana was also shown to be at least as effective as the antidiabetic medicines glimepiride and sitagliptin after 52 weeks of treatment;
  • the study conducted in patients with moderate renal insufficiency has shown that the efficacy of Invokana, although lower in these subjects, is still clinically relevant: the 100 mg dose induced a reduction in HbA1c levels greater than 0.3 % compared to placebo;
  • the study conducted on older patients finally revealed a "clinically significant efficacy of Invokana even in subjects over 75 years of age: taken at doses of 300 mg and 100 mg, Invokana induced a decrease in HbA1c levels greater than placebo 0.70% and 0.57%, respectively.

What is the risk associated with Invokana - canagliflozin?

The most common side effects of Invokana are hypoglycaemia (low blood glucose levels) when given in combination with insulin or a sulphonylurea, vulvovaginal candidiasis (a "fungal infection of the female genital area caused by Candida), urinary tract infection (infection of the structures responsible for the transport of urine) and polyuria (production of an excessive amount of urine) or pollakiuria (abnormal increase in the frequency of urination).

For the full list of side effects reported with Invokana, see the package leaflet.

Why has Invokana - canagliflozin been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Invokana's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Invokana has been shown to be effective. lowering blood glucose levels. Invokana therapy also induced weight loss and lower blood pressure, two effects that are considered beneficial in patients with diabetes. The safety profile was considered similar to that of other medicines belonging to of the same class (SGLT2 inhibitors) Important side effects have been identified, including dehydration and urinary tract infection, but these effects were considered manageable.

What measures are being taken to ensure the safe and effective use of Invokana - canagliflozin?

A risk management plan has been developed to ensure that Invokana is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Invokana, including the appropriate precautions to be followed by healthcare professionals and patients.

More information about Invokana - canagliflozin

On 15.11.2013 the European Commission granted a "Marketing Authorization" for Invokana, valid throughout the European Union. For more information on treatment with Invokana, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 11-2013


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