Vokanamet - canagliflozin and metformin

What is Vokanamet and what is it used for - canagliflozin and metformin?

Vokanamet is a medicine that contains the active substances canagliflozin and metformin. It is used as an adjunct to diet and exercise to control blood glucose (sugar) levels in adult patients with type 2 diabetes mellitus not adequately controlled on metformin alone; it is also used in combination with other medicines. antidiabetics, including insulin, when these medicines, in combination with metformin, do not provide adequate control of diabetes. Vokanamet can also be used as a replacement for canagliflozin and metformin taken separately.

How is Vokanamet used - canagliflozin and metformin?

Vokanamet is available as tablets containing canagliflozin and metformin in various strengths (50/850 mg, 150/850 mg, 50/1000 mg and 150/1000 mg) and can only be obtained with a prescription. The recommended dose is one tablet twice a day. The dosage of the tablet depends on the therapy followed by the patient before starting treatment with Vokanamet. The starting dose of Vokanamet should provide canagliflozin at a dose of 50 mg and the dose of metformin already taken (or closer to therapeutically appropriate). The dose of canagliflozin can subsequently be increased as needed.

When Vokanamet is used as add-on therapy to insulin or to medicines that promote insulin production (for example, sulphonylureas), the dose of these medicines may need to be reduced to decrease the risk of the patient's blood sugar falling too low. For more information, see the package leaflet.

How does Vokanamet - canagliflozin and metformin 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. Vokanamet contains two different active ingredients, each with a different mechanism of action:

• 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) when the blood is filtered into the kidneys. By blocking the action of SGLT2, canagliflozin induces the elimination of more glucose in the urine and, consequently, the reduction of the concentration of glucose in the blood. Canagliflozin as separate tablets is authorized in the EU under the trade name Invokana since November 15, 2013.
• Metformin works primarily by inhibiting the production of glucose and reducing its absorption in the intestine. It has been available in the EU since the 1950s.

Thanks to the combined action of the two active ingredients, the blood glucose level is reduced and this serves to control type 2 diabetes.

What benefit has Vokanamet - canagliflozin and metformin shown during the studies?

The benefits of canagliflozin used in combination with metformin have emerged from several main studies, which were evaluated under the authorization of Invokana. The studies, involving over 5,000 adults with type 2 diabetes, looked at the effects of canagliflozin. taken at daily doses of 100 and 300 mg, examining in particular the mechanism of reducing the blood level of a substance called glycosylated hemoglobin (HbA1c), which gives an "indication of the efficacy of glucose control. In the" context of two studies that evaluated the efficacy of canagliflozin as add-on therapy to metformin, the reduction in HbA1c levels after 26 weeks was 0.91-1.16% greater than placebo (a dummy treatment) when canagliflozin was added to metformin; canagliflozin also induced reductions similar to those of two other antidiabetic medicines, glimepiride and sitagliptin, after 52 weeks of treatment. Three further studies looked at canagliflozin used as add-on therapy to a combination treatment with metformin and a sulphonylurea or pioglitazone.Added to metformin and a sulphonylurea, canagliflozin resulted in 0.71-0.92% greater reductions in HbA1c levels than reductions seen with placebo after 26 weeks of treatment and similar reductions as seen with sitagliptin (another diabetic medicine) after 52 weeks. Added to metformin and pioglitazone, canagliflozin was superior to placebo, as it resulted in 0.62-0.76% greater reductions in HbA1c levels than seen with the addition of placebo. Canagliflozin was also studied as add-on therapy. in patients taking insulin alone, or insulin in combination with other antidiabetic medicines, including metformin, and in patients taking a sulphonylurea. Adding canagliflozin to therapy was effective compared to placebo in reducing HbA1c levels by 0, 65-0.73% after 18 weeks of therapy in patients treated with insulin and 0.74-0.83% of patients treated with a sulphonylurea.

What is the risk associated with Vokanamet - canagliflozin and metformin?

The most common side effects with Vokanamet (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose), if the medicine is used in combination with insulin or a sulphonylurea, and vulvovaginal candidiasis (a "fungal infection of the female genital area caused by Candida). Vokanamet should not be given to:

• patients with diabetic ketoacidosis or diabetic precoma (severe complications of diabetes);
• patients with moderate or severe renal impairment or with acute conditions with potential for renal impairment such as dehydration or severe infection;
• patients with a condition that may deprive tissues of oxygen (for example, heart or respiratory failure);
• patients with hepatic impairment or suffering from alcoholism or alcohol intoxication.

For the full list of restrictions, see the package leaflet.

Why has Vokanamet - canagliflozin and metformin been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vokanamet's benefits are greater than its risks and recommended that it be approved for use in the EU. The benefits of metformin are sufficiently demonstrated and studies have The additional benefit of adding canagliflozin to metformin for blood glucose control is ascertained. Metformin also induces weight loss, which is considered an advantage in diabetic patients. The CHMP also noted that the administration of the combination of canagliflozin and metformin in a single " tablet could represent an additional therapeutic option for people with type 2 diabetes and improve adherence to therapy.

Regarding safety, the CHMP is of the opinion that the side effects observed with Vokanamet are acceptable and manageable in clinical practice.

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

A risk management plan has been developed to ensure that Vokanamet 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 Vokanamet, including the appropriate precautions to be followed by healthcare professionals and patients.

Further information can be found in the summary of the risk management plan.

More information about Vokanamet - canagliflozin and metformin

On 23 April 2014, the European Commission granted a "Marketing Authorization" for Vokanamet, valid throughout the European Union. For more information on Vokanamet therapy, read the package leaflet (included with the EPAR) or consult your doctor. or the pharmacist. Last update of this summary: 05-2014

The information on Vokanamet - canagliflozin and metformin published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.