What is NovoRapid?
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).
What is NovoRapid used for?
NovoRapid is used to treat adults, adolescents and children over 2 years of age with diabetes.
The medicine can only be obtained with a prescription.
How is NovoRapid used?
Novorapid is given by subcutaneous injection (under the skin) into the abdominal wall (belly), thigh, upper arm, shoulder or buttock. NovoRapid is a fast-acting insulin. It is normally administered immediately before a meal but, if necessary, can be given after a meal. NovoRapid is normally used with an intermediate or prolonged insulin given at least once a day. To find the minimum effective dose the patient must be regularly tested for glucose (sugar) in the blood. The usual dose varies between 0.5 and 1.0 U / kg / day. If taken with a meal, 50 to 70% of the insulin requirement is supplied by NovoRapid and the remainder is from an intermediate or prolonged insulin. NovoRapid can be given to pregnant women.
NovoRapid can also be used with a continuous insulin pump infusion system. It can be given into a vein, but only by a doctor or nurse.
How does NovoRapid work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood. NovoRapid is a replacement insulin, which is very similar to the insulin produced by the body. The active substance in NovoRapid, insulin aspart, is produced by a method known as "recombinant DNA technique"; that is, it is obtained from a yeast in which a gene (DNA) has been inserted which makes it capable of producing insulin aspart.
Insulin aspart differs very little from human insulin; thanks to this difference, it is absorbed more quickly by the body, therefore it can act more quickly than human insulin. Replacement insulin acts like naturally produced insulin and helps glucose penetrate cells from the blood. By controlling the level of glucose in the blood, the symptoms and complications of diabetes are reduced.
How has NovoRapid been studied?
NovoRapid has been studied in two studies of 1954 patients with type 1 diabetes (in which the pancreas is unable to produce insulin) and in a study of 182 patients with type 2 diabetes (in which the body is not in able to use insulin effectively). In these studies NovoRapid was compared to human insulin by measuring the level in the blood of a substance called glycosylated hemoglobin (HbA1c) which gives an indication of the effectiveness of blood glucose control. The safety of NovoRapid was also compared with that of human insulin in two studies involving 349 pregnant women with type 1 diabetes or gestational diabetes (caused by pregnancy). NovoRapid has not been tested in children younger than two years.
What benefit has NovoRapid shown during the studies?
NovoRapid gave roughly the same results as human insulin. In the two studies on type 1 diabetes, NovoRapid reduced HbA1c levels by 0.12% and 0.15% more than human insulin did after six months. NovoRapid used during pregnancy exhibited the same safety profile as human insulin.
What is the risk associated with NovoRapid?
The most common side effect of 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 other ingredients. In addition, doses of NovoRapid may need to be adjusted when administered together with other medicines that may have an effect on blood glucose levels. The complete list can be found in the package leaflet.
Why has NovoRapid 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 the granting of a marketing authorization for NovoRapid.
More information on NovoRapid
On 7 September 1999, the European Commission issued a marketing authorization valid for NovoRapid to Novo Nordisk A / S valid throughout the European Union. The marketing authorization was renewed on 7 September 2004 and 7 September 2009.
The full EPAR for NovoRapid can be found here.
Last update of this summary: 09-2009.
