NovoMix - insulin aspart

What is NovoMix?

NovoMix comprises a series of injectable suspensions, available in cartridges or pre-filled pens. NovoMix contains the active ingredient insulin aspart 100 units (U) per milliliter in the following ratio:

• NovoMix 30: 30% soluble insulin aspart (fast acting) and 70% protamine-crystallized insulin aspart (long acting);
• NovoMix 50: 50% soluble insulin aspart (fast acting) and 50% protamine-crystallized insulin aspart (long acting);
• NovoMix 70: 70% soluble insulin aspart (fast acting) and 30% protamine-crystallized insulin aspart (long acting).

What is NovoMix used for?

NovoMix is ​​indicated for the treatment of patients with diabetes.
The medicine can only be obtained with a prescription.

How is NovoMix used?

NovoMix is ​​administered subcutaneously (under the skin) by injection into the abdominal wall or thigh. Alternatively, the deltoid (shoulder) or gluteal (buttocks) region can be used. To find the minimum effective dosage it is necessary to regularly monitor the serum level of glucose (sugars). NovoMix is ​​given immediately before a meal, but if necessary it can also be given immediately after a meal. Typically the dose is between 0.5 and 1.0 U per kilogram of body weight per day.
In patients with type 2 diabetes (also known as non-insulin-dependent diabetes), NovoMix can be given alone or in combination with metformin. NovoMix 30 can also be used with other antidiabetic medicines that can be taken by mouth in combination with insulin, but with pioglitazone it should only be given after assessing the patient's risk of experiencing side effects related to water retention. For more information, see the Summary of Product Characteristics, also included in the EPAR.

How does NovoMix work?

Diabetes mellitus is a disease in which the body does not make enough insulin to control glucose levels in the blood. NovoMix is ​​an insulin analog that is very similar to the insulin produced by the pancreas. The active substance in NovoMix, insulin aspart , it is made by a method known as 'recombinant DNA technology': it is made by a yeast that has received a gene (DNA) which enables it to produce insulin aspart. Insulin aspart differs very little from human insulin, but because of this difference it can be absorbed more quickly by the body and therefore can act faster than human insulin. NovoMix contains two forms of insulin aspart: the soluble form, which works quickly (within 10 minutes after injection), and the crystallized form, which is absorbed much more slowly over the course of the day. This gives NovoMix a longer action. The replacement insulin has the same mechanisms of action as natural insulin and promotes the penetration of glucose into blood cells. By controlling the blood sugar level, it reduces the symptoms and complications of diabetes.

How has NovoMix been studied?

NovoMix 30 was studied in patients with type 1 or type 2 diabetes (294 patients) and was compared over 12 weeks with human insulin. NovoMix 50 and NovoMix 70 administered by injection three times a day were compared in 664 patients (with type 1 or 2 diabetes) with human insulin 30 injected twice daily. In addition, 4 studies involving a total of 905 patients were conducted on the effects of NovoMix 30 as add-on therapy to other antidiabetic medicines taken by mouth (metformin, sulphonylurea and pioglitazone). In all of the studies, the main measure of effectiveness was the change in the blood concentration of a substance called glycosylated hemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled at the start and end of the study.

What benefit has NovoMix shown during the studies?

At the end of the study, NovoMix 30 gave mostly identical results to human insulin. NovoMix 50 and NovoMix 70 showed better overall blood glucose control than human insulin 30. NovoMix 30 used as add-on therapy to other antidiabetic drugs allowed to achieve better blood glucose control than other drugs used alone (alone).

What is the risk associated with NovoMix?

Like other types of insulin, NovoMix can cause hypoglycaemia (a decrease in the concentration of glucose in the blood). For the full list of side effects reported with NovoMix, see the Package Leaflet.
NovoMix must not be used in people who may be hypersensitive (allergic) to insulin aspart or any of the ingredients, or in patients with hypoglycaemia. The dosage of NovoMix may also need to be adjusted when administered concomitantly with other medicines that may affect blood glucose. See package leaflet for complete list.

Why has NovoMix been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that NovoMix's benefits are greater than its risks for the treatment of diabetes mellitus. The Committee therefore recommended the granting of a marketing authorization for NovoMix.

Other information about NovoMix:

On 1 August 2000, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for NovoMix, valid throughout the European Union. The "Marketing Authorization" was renewed on 1 August 2005.
For the complete NovoMix EPAR version click here.

Last update of this summary: 08-2007


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