Liprolog

insulin lispro

This is a summary of the European Public Assessment Report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).

What is Liprolog?

Liprolog is a range of solutions and suspensions for injection. Liprolog is supplied in vials, cartridges or in prefilled pens (Liprolog Pen and Liprolog KwikPen). Liprolog contains the active substance insulin lispro. The Liprolog range is comprised of fast-acting insulin solutions (Liprolog), longer-acting insulin suspensions (Liprolog Basal), and combinations of both in various proportions (Liprolog Mix):

• Liprolog: insulin lispro solution;
• Liprolog Basal: insulin lispro protamine suspension;
• 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 to treat adults and children who have diabetes and need insulin to keep their blood glucose (sugar) level controlled, including patients whose diabetes has just been diagnosed.

The medicine is only available with a prescription.

How is Liprolog used?

Liprolog, Liprolog Basal and Liprolog Mix may be given by injection under the skin of the upper arm, thigh, buttock or abdomen (tummy). Liprolog may also be given by continuous infusion using an insulin pump or into a vein.

Liprolog and Liprolog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary. Liprolog can be used with a longer-acting insulin or with sulphonylureas (a group of antidiabetic medicines that are taken by mouth).

Liprolog Basal can be used alone or in combination with medicines taken by mouth. If intensive insulin therapy is needed, Liprolog Basal can be given in the morning or evening, together with a 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 when the body is unable to use insulin effectively. Liprolog is a replacement insulin, which very similar to the insulin made by the pancreas.

The active substance in Liprolog, insulin lispro, is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin lispro. Insulin lispro is very slightly different from human insulin. The change means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster. Insulin lispro is available as Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘protamine suspension’ form, which is absorbed much more slowly so that it works for longer. Liprolog Mix is a mixture of these two formulations.

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 Liprolog been studied?

Liprolog was originally studied in eight clinical trials including 2,951 patients with type 1 or type 2 diabetes. The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when they were added to long-acting insulins given once or twice a day. The studies measured the level of a substance in the blood called ‘glycosylated haemoglobin’ (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘fasting’ blood glucose levels (measured at least eight hours after eating). Studies were also done looking at the use of Liprolog in 542 children and adolescents (aged between two and 19 years), and the use of Liprolog in combination with sulphonylureas (antidiabetic medicines taken by mouth).

What benefit has Liprolog shown during the studies?

Liprolog and Humulin R had a similar effect on the control of diabetes, as measured by HbA1c and fasting glucose levels.

What is the risk associated with Liprolog?

Liprolog may cause hypoglycaemia (low blood glucose). For the full description of all side effects reported with Liprolog, see the Package Leaflet.

Liprolog should not be used in people who may be hypersensitive (allergic) to insulin lispro or any of the other ingredients. Liprolog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels. The full list of these medicines is available in the Package Leaflet. Liprolog Mix and Liprolog Basal should never be given into a vein.

Why has Liprolog been approved?

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

Other information about Liprolog:

The European Commission granted marketing authorisations valid throughout the European Union for Liprolog to Eli Lilly Nederland B V. on 1 August 2001. The marketing authorisation was renewed on 1 August 2006.

This EPAR was last updated on 11/05/2011 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

24/03/2011  Liprolog -EMEA/H/C/000393 -WS/0105

Contents

• Annex I - Summary of product characteristics
• Annex IIA - Manufacturing-authorisation holder responsible for batch release
• Annex IIB - Conditions of the marketing authorisation
• Annex IIIA - Labelling
• Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents