Vokanamet
Authorised
canagliflozin / metformin
Medicine
Human
Authorised
This is a summary of the European public assessment report (EPAR) for Vokanamet. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vokanamet.
For practical information about using Vokanamet, patients should read the package leaflet or contact their doctor or pharmacist.
Vokanamet is a diabetes medicine that contains the active substances canagliflozin and metformin. It is used, together with diet and exercise, to control the blood glucose (sugar) levels in adults with type 2 diabetes whose disease is not satisfactorily controlled with metformin alone, or in combination with other diabetes medicines, including insulin, when these medicines together with metformin are not providing adequate control of the diabetes. Vokanamet can also be used to replace canagliflozin and metformin given separately.
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 taken twice a day. The tablet strength depends on the patient’s treatment before starting Vokanamet. Patients should start Vokanamet at a strength that provides 50 mg canagliflozin and the dose of metformin they were previously taking (or a close approximation of it). The dose of canagliflozin can then be increased if needed.
When Vokanamet is used as an add-on to insulin or medicines that stimulate the secretion of insulin (e.g. sulphonylureas) the dose of these other medicines may need to be reduced to lower the risk of the patient’s blood glucose becoming too low.
For further information, see the package leaflet.
Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively. This leads to high levels of glucose in the blood.
Vokanamet contains two different active substances, which work in different ways:
As a result of the action of both active substances, the blood glucose is reduced and this helps to control type 2 diabetes.
The benefits of canagliflozin used in combination with metformin have been shown in several main studies that were evaluated at the time of the authorisation of Invokana. The studies, involving over 5,000 adults with type 2 diabetes, studied canagliflozin at daily doses of 100 and 300 mg and looked mainly at how they reduced the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
In two studies evaluating canagliflozin as an add-on to metformin, the reductions in HbA1c levels after 26 weeks was 0.91 to 1.16 percentage points higher with canagliflozin than with placebo (a dummy treatment) when added to metformin and canagliflozin achieved similar reductions to two other diabetes medicines, glimepiride and sitagliptin, after 52 weeks of treatment.
Three further studies evaluated canagliflozin as an add-on to combined treatment with metformin and either a sulphonylurea or pioglitazone. Added to metformin and a sulphonylurea, canagliflozin led to reductions in HbA1c that were between 0.71 and 0.92percentage points more than those seen with placebo after 26 weeks and similar to those seen with sitagliptin (another diabetes medicine) after 52 weeks. Added to metformin and pioglitazone, canagliflozin was also superior to placebo, leading to HbA1c reductions that were 0.62 and 0.76 points more than was seen by adding placebo.
Canagliflozin was also studied as an add-on treatment in patients who were taking insulin alone, or insulin in combination with other diabetes medicines including metformin and in patients who were taking a sulphonylurea. Adding canagliflozin to treatment was shown to be effective at reducing HbA1c compared with placebo by 0.65 to 0.73 points after 18 weeks in patients receiving insulin and by 0.74 to 0.83 points in patients receiving a sulphonylurea.
The most common side effects with Vokanamet (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose levels) when used in combination with insulin or a sulphonylurea and vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida).
Vokanamet must not be used in:
For the full list of restrictions, see the package leaflet.
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 well established and the added advantage of adding canagliflozin to metformin to control blood sugar has been shown in the studies. It also leads to weight loss, which is considered beneficial in patients with diabetes. The CHMP also noted that giving the combination of canagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Concerning its safety, the CHMP considered that the side effects seen with Vokanamet are acceptable and can be managed in clinical practice.
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 included in the summary of product characteristics and the package leaflet for Vokanamet, including the appropriate precautions to be followed by healthcare professionals and patients.
Further information can be found in the risk-management-plan summary.
The European Commission granted a marketing authorisation valid throughout the European Union for Vokanamet on 23 April 2014.
For more information about treatment with Vokanamet, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
Vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.