PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Liprolog?
Liprolog includes a series of injectable solutions and suspensions. It is supplied in vials, cartridges or pre-filled pens (Liprolog Pen and Liprolog KwikPen). Insulin lispro is the active ingredient in the medicine. The Liprolog range includes fast-acting insulin solutions (Liprolog), long-acting insulin suspensions (Liprolog Basal) and combinations of both in different dosages (Liprolog Mix):
- Liprolog: insulin lispro solution;
- Liprolog Basal: suspension of insulin lispro protamine;
- Liprolog Mix25: 25% insulin lispro solution and 75% insulin lispro protamine suspension;
- Liprolog Mix50: 50% insulin lispro solution and 50% insulin lispro protamine suspension.
What is Liprolog used for?
Liprolog is used in the treatment of diabetic patients (adults and children) who require insulin to control the level of glucose (sugar) in the blood, including patients whose diabetes has been recently diagnosed.
The medicine can only be obtained with a prescription.
How is Liprolog used?
Liprolog, Liprolog Basal and Liprolog Mix can be administered by subcutaneous injection in the upper arm, thigh, buttocks or abdomen. Liprolog can also be administered by continuous infusion using an insulin pump or intravenously.
Liprolog and Liprolog Mix should normally be given just before meals, but they can also be administered immediately after a meal, where necessary. Liprolog can be used with long-acting insulin or sulfonylureas (anti-diabetes medicines taken orally).
Liprolog Basal can be taken individually or in combination with oral medications. If intensive insulin therapy is required, Liprolog Basal can be taken in the morning or evening, along with fast-acting insulin at mealtimes.
How does Liprolog work?
Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or in which the body is unable to effectively use the insulin produced. Liprolog is a replacement insulin very similar to the insulin produced by the pancreas.
The active substance in Liprolog, insulin lispro, is produced with a so-called "recombinant DNA" technology. This technique uses a bacterium in which a gene (DNA) is inserted that makes it capable of producing insulin lispro. Insulin lispro is little different from the insulin produced by the human body; the difference lies in the fact that insulin lispro is absorbed more quickly by the body than normal human insulin and therefore acts faster. Insulin lispro is available as a liprolog, in a soluble form, but which acts more or less immediately after the injection, and as Liprolog Basal in the form of a "protamine suspension", which is absorbed much more slowly so as to act longer. . Liprolog Mix contains a mixture of these two formulations.
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 Liprolog been studied?
Liprolog was initially the subject of eight clinical studies involving 2 951 patients with type 1 or type 2 diabetes. The efficacy of Liprolog was compared with that of Humulin R (human insulin in a recombinant DNA form) when added at one or two daily doses of long-acting insulins. The studies measured the level of a substance in the blood, glycosylated hemoglobin (HbA1c), which provides an indication of the effectiveness of blood glucose control and fasting blood glucose levels (measured no less than eight hours since the last meal). Studies were also initiated aimed at evaluating the use of Liprolog in 542 children and adolescents (aged between 2 and 19 years) as well as the use of Liprolog in combination with sulfonylureas (oral anti-diabetes medicines) .
What benefit has Liprolog shown during the studies?
Based on HbA1c and fasting glucose levels, no significant differences were found between Liprolog and Humulin R in controlling diabetes.
What is the risk associated with Liprolog?
Liprolog may cause hypoglycaemia (reduced blood glucose level). For the full list of all side effects reported with Liprolog, see the Package Leaflet.
Liprolog should not be used in patients who may be hypersensitive (allergic) to insulin lispro or any of the other components. Liprolog doses may need to be changed when given with other medicines which may have an effect on blood glucose levels. For a complete list of these medicines, see the package leaflet. Under no circumstances may Liprolog Mix and Liproglog Basal be administered intravenously.
Why has Liprolog been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Liprolog's benefits for treating diabetes mellitus are greater than its risks and therefore recommended that it be given marketing authorization.
More information on Liprolog:
On 1 August 2001, the European Commission granted a marketing authorization valid throughout the European Union for Liprolog to Eli Lilly Nederland BV. On 1 August 2006 the marketing authorization was renewed.
The full EPAR for Liprolog can be found here.
Last update of this summary: 06-2008
