Humalog

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 Humalog?

Humalog is a range of solutions and suspensions for injection. Humalog is supplied in vials, cartridges or in prefilled pens (Humalog Pen, Humaject). Humalog contains the active ingredient insulin lispro. The Humalog range comprises fast-acting insulin solutions (Humalog), longer-acting insulin suspensions (Humalog NPL), and combination of both in various proportions (Humalog Mix):

• Humalog: insulin lispro solution
• Humalog NPL: insulin lispro protamine suspension
• Humalog Mix25: 25% insulin lispro solution and 75% insulin lispro protamine suspension
• Humalog Mix50: 50% insulin lispro solution and 50% insulin lispro protamine suspension

What is Humalog used for?

Humalog is used to treat adults and children who have diabetes and need insulin to keep their blood sugar level controlled, including those patients whose diabetes has just been diagnosed.

The medicine is only available with a prescription.

How is Humalog used?

Humalog, Humalog NPL and Humalog Mix may be given subcutaneously (under the skin) by injection into the upper arms, thighs, buttocks, or abdomen (tummy). Humalog may also be given by continuous infusion using an insulin pump or intravenously (into a vein). Humalog and Humalog Mix products are normally given shortly before a meal and may be given soon after a meal if necessary. Humalog can be used with a longer-acting insulin or oral diabetic medicines (sulphonylureas). Humalog NPL can be mixed with or given in conjunction with Humalog.

How does Humalog work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood sugar. Humalog is a replacement insulin which very similar to the insulin made by the pancreas. The active ingredient of Humalog, 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, and the change means that it is absorbed faster by the body, and can therefore act faster than human regular insulin. Insulin lispro products are available in various forms: as Humalog in the soluble form, which acts quickly (more or less immediately after injection), and as Humalog NPL in the protamine suspension form which is absorbed much more slowly during the day; and give a longer duration of action. Humalog Mix is a mixture between these both 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 sugar, the symptoms and complications of diabetes are reduced.

How has Humalog been studied?

Humalog was originally studied in eight clinical trials including 2951 diabetic patients with type 1 or type 2 diabetes. The effectiveness of Humalog was compared to Humulin R (a soluble recombinant DNA human insulin), when added to one or two daily doses of long-acting insulins. The studies measured the level of glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and fasting glucose levels. Further studies were also done looking at the use of Humalog in 542 children and adolescents (aged 2 to 19), and the use of Humalog in combination with sulphonylureas (oral anti-diabetes medicines).

What benefit has Humalog shown during the studies?

There were no statistical differences between Humalog and Humulin on diabetic control measured by glycosylated haemoglobin or fasting glucose levels.

What is the risk associated with Humalog?

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

Humalog should not be used in people who may be hypersensitive to any of the ingredients. Humalog doses might also need to be adjusted when given with a number of other medicines which may have an effect on blood sugar (the full list is available in the Package Leaflet).

Under no circumstances should Humalog Mix or Humalog NPL be given intravenously.

Why has Humalog been approved?

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

Other information about Humalog

The European Commission granted marketing authorisations valid throughout the European Union, for Humalog to Eli Lilly Netherland B.V. on 30 April 1996. This was renewed on 30 April 2001.

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  Humalog -EMEA/H/C/000088 -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. Humalog is also indicated for the initial stabilisation of diabetes mellitus.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents