NovoMix

insulin aspart

This is a summary of the European Public Assessment Report (EPAR) for NovoMix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NovoMix. For more information about treatment with NovoMix, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.

What is NovoMix?

NovoMix is a range of suspensions for injection, which are available in cartridges (Penfill) and prefilled pens (FlexPen). NovoMix contains the active substance insulin aspart (100 units [U] per millilitre) in three forms:

• NovoMix 30 contains 30% soluble (rapid-acting) insulin aspart and 70% protamine-crystallised (intermediate-acting) insulin aspart;
• NovoMix 50 contains 50% soluble and 50% protamine-crystallised insulin aspart;
• NovoMix 70 contains 70% soluble and 30% protamine-crystallised insulin aspart.

What is NovoMix used for?

NovoMix is used to treat diabetes. NovoMix 30 can be used in patients aged 10 years or over.

NovoMix 50 and NovoMix 70 can only be used in adults (aged 18 years or over).

The medicine can only be obtained with a prescription.

How is NovoMix used?

NovoMix is injected under the skin of the abdominal wall (tummy) or the thigh. It can also be injected under the skin in the deltoid (shoulder) or gluteal (buttock) regions, if convenient. The patient’s blood glucose (sugar) levels should be tested regularly to find the lowest effective dose. NovoMix is given 

immediately before a meal, but may be given after a meal if necessary. The usual dose is between 0.5 and 1.0 U per kilogram body weight per day.

In type 2 diabetes, NovoMix can be given on its own or together with metformin (another antidiabetes medicine). NovoMix 30 can also be used with other antidiabetes medicines that are taken by mouth, but it should only be used with pioglitazone once the doctor has evaluated the patient’s risk of fluid-related side effects. For more information, see the summary of product characteristics (also part of the EPAR).

Patients can inject themselves with NovoMix once they have been trained appropriately.

How does NovoMix work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. NovoMix is a replacement insulin that is very similar to the insulin made by the pancreas.

The active substance in NovoMix, insulin aspart, is produced by a method known as ‘recombinant DNA technology’: it is made by a yeast that has received a gene (DNA), which makes it able to produce insulin aspart.

Insulin aspart is very slightly different from human insulin. The change means that it is absorbed faster by the body than human insulin, and therefore starts to work sooner. NovoMix contains insulin aspart in two forms: the soluble form, which works within 10 minutes of injection and the crystallised form, which is absorbed much more slowly during the day. The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has NovoMix been studied?

NovoMix 30 has been compared with biphasic human insulin 30 (a combination of 30% rapid-acting and 70% intermediate-acting human insulin) in 294 adults with type 1 diabetes (when the pancreas cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively), and in 167 patients aged between 10 and 17 years with type 1 diabetes. NovoMix 50 and NovoMix 70 have been compared with biphasic human insulin 30 in 664 patients with type 1 or type 2 diabetes.

The effects of adding NovoMix 30 to other antidiabetes medicines taken by mouth (metformin, sulphonylureas and pioglitazone) have also been studied in four studies involving a total of 905 patients.

In all of the studies, the main measure of effectiveness was the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, over 12 to 28 weeks, or the change in blood glucose levels seen after a meal.

What benefit has NovoMix shown during the studies?

NovoMix 30 gave almost identical results to biphasic human insulin 30 at the end of the studies. NovoMix 50 and NovoMix 70 gave better overall control of blood glucose than biphasic human insulin 30. Adding NovoMix 30 to other antidiabetes medicines also resulted in better control of blood glucose than the other medicines taken alone.

What is the risk associated with NovoMix?

The most common side effect with NovoMix (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with NovoMix, see the Package Leaflet.

NovoMix should not be used in people who may be hypersensitive (allergic) to insulin aspart or to any of the other ingredients. NovoMix doses might also need to be adjusted when given with other medicines that may have an effect on blood glucose levels. For the full list of these medicines, see the Package Leaflet.

Why has NovoMix been approved?

The CHMP decided that NovoMix’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about NovoMix

The European Commission granted a marketing authorisation valid throughout the European Union for NovoMix to Novo Nordisk A/S on 1 August 2000. The marketing authorisation is valid for an unlimited period.

This EPAR was last updated on 11/05/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

20/03/2012  NovoMix -EMEA/H/C/000308 -N/0071

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents