Active Substance: insulin aspart
Common Name: insulin aspart
ATC Code: A10AB05
Marketing Authorisation Holder: Novo Nordisk A/S
Active Substance: insulin aspart
Status: Authorised
Authorisation Date: 1999-09-07
Therapeutic Area: Diabetes Mellitus
Pharmacotherapeutic Group: Drugs used in diabetes

Therapeutic Indication

Treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

What is NovoRapid?

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

What is NovoRapid 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 NovoRapid 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. The injection site should be changed for each injection. 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 in combination 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 units per kilogram body weight per 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 under the skin or alternatively, it can be given into a vein but only by a doctor or a nurse.

How does NovoRapid 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 yeast cells into which a gene (DNA) has been introduced that makes them 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 than human insulin. 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 NovoRapid 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 benefit has NovoRapid 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 with NovoRapid?

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.

For the full list of restrictions, see the package leaflet.

Why has NovoRapid been approved?

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

What measures are being taken to ensure the safe and effective use of NovoRapid?

A risk management plan has been developed to ensure that NovoRapid 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 NovoRapid, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about NovoRapid

The European Commission granted a marketing authorisation valid throughout the European Union for NovoRapid on 7 September 1999.

For more information about treatment with NovoRapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.