What is Invokana - canagliflozin used for and what is it used for?
Invokana is a diabetes medicine containing the active substance canagliflozin . It is indicated in adult patients with type 2 diabetes mellitus to improve blood glucose (sugar) control. 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 an adjunctive therapy in combination with other antidiabetic medicines, including insulin, when these medicines, together with diet and exercise, do not provide adequate diabetes control.
How is Invokana - canagliflozin used?
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 necessary, the dose can be increased to 300 mg once a day. Because the effects of Invokana depend 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 impairment. In patients with moderate renal impairment, the dose should be limited to 100 mg once a day. 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 where the body is unable to use insulin effectively, which leads to increased levels of glucose in the blood. The active substance in Invokana, canagliflozin, works by blocking a protein in the kidneys called the type 2 sodium-glucose transporter (SGLT2). SGLT2 is a protein responsible for the reabsorption of glucose into the bloodstream (bloodstream) from urine, when blood is filtered through the kidneys. By blocking the action of SGLT2, Invokana induces the elimination of more glucose through the urine and, consequently, 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 about 10, 000 patients with type 2 diabetes. One of the studies compared Invokana, used on its own in patients with inadequately controlled blood glucose levels. diet and exercise, with placebo (a dummy treatment). Three studies examined the efficacy of Invokana used as an adjunctive therapy in combination with another antidiabetic medicine (metformin or insulin), while three other studies analyzed the effectiveness of Invokana used as adjunctive therapy in combination with two other antidiabetic medicines (including metformin ), in patients in whom therapy with such drugs, in addition to diet and exercise, was not sufficient to ensure adequate diabetes control. Finally, a study was conducted on patients with moderate renal impairment, while another study included patients aged 55 to 80 years. In all 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 the effectiveness of blood glucose control. Invokana was more effective than placebo and at least as effective as the comparator medicines in reducing HbA1c levels, if used either as monotherapy or in combination with other antidiabetic medicines:
- used as monotherapy 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% reduction compared to placebo placebo;
- in the studies examining the efficacy of Invokana taken in combination with another 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 a dose of 300 mg, 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 has also been shown to be at least as effective as the anti-diabetic medicines glimepiride and sitagliptin after 52 weeks of treatment;
- the study conducted in patients with moderate renal impairment showed that the effectiveness of Invokana, although lower in these subjects, is still clinically relevant: the 100 mg dose led to a reduction of HbA1c levels higher than 0.3 % compared to placebo;
- finally, from the study conducted on older patients, clinically significant efficacy of Invokana emerged even in subjects over 75 years of age: taken at doses of 300 mg and 100 mg, Invokana induced a decrease in HbA1c levels above placebo of 0.70% and 0.57%, respectively.
What is the risk associated with Invokana - canagliflozin?
The most common side effects of Invokana are hypoglycaemia (reduced blood glucose levels), when given in combination with insulin or a sulphonylurea, vulvovaginal candidiasis (a fungal infection in the female genital area caused by Candida), urinary tract infection (infection of the structures assigned to transport urine) and polyuria (production of an excessive amount of urine) or pollakiuria (anomalous increase in the frequency of urination).
For the full list of all 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 in reducing blood glucose levels. Invokana therapy also induced weight loss and reduced 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 the same class (SGLT2 inhibitors). Important undesirable 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 included in the summary of product characteristics and the package leaflet for Invokana, including the appropriate precautions to be followed by healthcare professionals and patients.
Other information on Invokana - canagliflozin
On 15.11.2013 the European Commission issued a marketing authorization for Invokana, valid throughout the European Union. For more information about treatment with Invokana, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 11-2013
