Author: Novo Nordisk A/S


Long information

What is it?

NovoRapid is a solution for injection that contains the active substance insulin aspart. It is available in vials, cartridges (PenFill) and pre-filled pens (NovoLet, FlexPen and InnoLet).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

NovoRapid is used to treat adults, adolescents and children over the age of two years who have diabetes.
The medicine can only be obtained with a prescription.

How is it used?

NovoRapid is given as an injection under the skin in the abdominal (tummy) wall, the thigh, the upper arm, the shoulder or the buttock. NovoRapid is a rapid-acting insulin. It is usually given immediately before a meal, although it may be given after a meal if necessary. NovoRapid is normally used with an intermediate- or long-acting insulin given at least once a day. The patient?s blood glucose (sugar) should be tested regularly to find the lowest effective dose. The usual dose is between 0.5 and 1.0 U/kg/day. When it is used with meals, 50 to 70% of the insulin requirement may be provided by NovoRapid and the remainder by an intermediate or long-acting insulin. NovoRapid can be used in pregnant women.
NovoRapid can also be used in a pump system for continuous insulin infusion. It can be given into a vein but only by a doctor or a nurse.

How does it work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. NovoRapid is a replacement insulin that is very similar to the insulin made by the body. The active substance in NovoRapid, 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, and can therefore act faster that human insulin. The replacement insulin acts in 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 it been studied?

NovoRapid has been studied in two studies involving 1,954 patients with type 1 diabetes(when the pancreas cannot produce insulin) and in one study involving 182 patients with type 2 diabetes (when the body is unable to use insulin effectively). The studies compared NovoRapid with human insulin by measuring the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. The safety of NovoRapid has also been compared with that of human insulin in two studies involving 349 pregnancies in women with type 1 or gestational diabetes (diabetes caused by pregnancy). NovoRapid has not been studied in children below two years of age.

What benefits has it shown during the studies?

NovoRapid gave almost identical results to human insulin. In the two studies in type 1 diabetes, NovoRapid reduced HbA1c levels by 0.12% and by 0.15% more than human insulin did after six months. NovoRapid had the same safety profile as human insulin when used during pregnancy.

What is the risk associated?

The most common side effect with NovoRapid (seen in between 1 and 10 patients in 100) is hypoglycaemia (low blood glucose levels). For the full list of all side effects reported with NovoRapid, see the Package Leaflet.
NovoRapid should not be used in people who may be hypersensitive (allergic) to insulin aspart or any of the ingredients. NovoRapid doses might also need to be adjusted when given with some of other medicines that may have an effect on blood glucose levels. The full list is available in the Package Leaflet.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that NovoRapid?s benefits are greater than its risks for the treatment of diabetes mellitus. The Committee recommended that NovoRapid be given marketing authorisation.

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