Levemir - insulin detemir
What is Levemir?
Levemir is a solution for injection that contains the active substance insulin detemir. It is available in cartridges (PenFill) and pre-filled pens (FlexPen and InnoLet).
What is Levemir used for?
Levemir is used to treat adults, adolescents and children over 6 years of age with diabetes.
The medicine can only be obtained with a prescription.
How is Levemir used?
Levemir is given by injection under the skin in the abdominal wall (belly), thighs, upper arms, shoulders or buttocks. Levemir is a long-acting "insulin that can be used in the following ways:
- once daily in combination with oral antidiabetic medicinal products. It can be administered at any time of day, provided that this time is the same every day. The dose of Levemir should be adjusted according to each patient's blood glucose (sugar) levels;
- in combination with injections of a "short-acting or fast-acting insulin during meals. Levemir should be administered once or twice a day, depending on the patient's needs."
The patient's blood glucose level should be checked regularly to find the lowest effective dose.
How does Levemir work?
Diabetes is a disease caused by the body not producing enough insulin to control the level of glucose in the blood. Levemir is a replacement insulin very similar to that produced by the body. The active ingredient in Levemir, Insulin detemir is produced by a method known as 'recombinant DNA technology': it is made by a yeast that is enriched with a gene (DNA), which makes it able to produce insulin detemir.
Insulin detemir is slightly different from human insulin. This difference leads to its slower absorption in the organism with longer times to reach the goal in the organism, which implies that Levemir has a long-lasting action. Replacement insulin acts like naturally produced insulin and helps glucose enter cells from the blood. By controlling the blood glucose level, the symptoms and complications of diabetes are reduced.
How has Levemir been studied?
Levemir has been studied in 1,575 patients with type 1 diabetes (in which the pancreas is unable to produce insulin) and in over 2,400 patients with type 2 diabetes (in which the body is unable to use the " insulin effectively). These studies compared Levemir to human NPH insulin (an "intermediate-acting insulin) or to insulin glargine (a" long-acting "insulin) given once or twice a day. Fast-acting insulin injections were also given at mealtimes. In four of the six type 2 diabetes studies, patients were also given one or two antidiabetic drugs by mouth. All the studies measured the level of a substance in the blood called glycosylated hemoglobin (HbA1c), which gives an "indication of how well the blood glucose is controlled." Levemir has not been studied in children under the age of six.
What benefit has Levemir shown during the studies?
Studies revealed that Levemir controls blood glucose levels in a similar way to NPH insulin, with less risk of low blood glucose levels at night and no weight gain. Combined with orally administered antidiabetic drugs, Levemir it also controlled blood glucose levels in a similar way to insulin glargine.
What is the risk associated with Levemir?
The most common side effects seen with Levemir (seen in between 1 and 10 patients in 100) are hypoglycaemia (low blood glucose levels) and injection site reactions (pain, redness, rash, inflammation, bruising of the skin, swelling and itching. ). For patients who are also taking oral antidiabetic medicines, there are also signs of allergy in 1 to 10 patients in 100. For a complete list of all side effects reported with Levemir, see the package leaflet.
Levemir should not be used in patients who may be hypersensitive (allergic) to insulin detemir or any of the other ingredients. Levemir doses should be adjusted when given with certain other medicines which may have an effect on blood glucose levels. L "full list is available in the package leaflet.
Why has Levemir been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that Levemir's benefits for the treatment of diabetes mellitus are greater than its risks. The Committee therefore recommended the granting of a marketing authorization for Levemir.
Learn more about Levemir
On 1 June 2004, the European Commission granted Novo Nordisk A / S a "Marketing Authorization" for Levemir, valid throughout the European Union. The "Marketing Authorization" was renewed on 1 June. 2009.
For the full version of Levemir's EPAR, click here.
Last update of this summary: 06-2009
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