What is Humalog - Insulin lispro?
Humalog includes a range of injectable solutions and suspensions supplied in vials, cartridges and pre-filled pens (Humalog Pen, Humaject). The active ingredient is insulin lispro. The Humalog series includes fast-acting insulin solutions (Humalog), protracted insulin suspensions (Humalog NPL) and combinations of both in various proportions (Humalog Mix):
Humalog: insulin lispro solution
Humalog NPL: suspension of insulin lispro protamine
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 - Insulin lispro?
Humalog is used to treat adults and children with diabetes mellitus who require insulin to control blood glucose levels, including patients who have recently been diagnosed with diabetes.
The medicine can only be obtained with a prescription.
How is Humalog used - Insulin lispro?
Humalog, Humalog NPL and Humalog Mix can be administered by subcutaneous injection (under the skin) performed in the upper arm, thigh, buttocks or abdomen (belly). Humalog can also be administered by continuous subcutaneous infusion using an insulin pump or intravenously. Humalog and Humalog Mix should normally be given shortly before meals and possibly immediately after meals. Humalog can be used in combination with long-acting insulin or anti-diabetic medicines taken by mouth (sulfonylureas). Humalog NPL can be mixed or taken with Humalog.
How does Humalog - Insulin lispro work?
Diabetes is a disease due to the fact that the body does not produce enough insulin to control the level of sugar in the blood. Humalog is a replacement insulin very similar to the insulin produced by the pancreas. The active substance in Humalog is insulin lispro, produced with the 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 differs very little from the insulin produced by the human body, moreover it is absorbed more quickly by the body, therefore it can act more quickly than the natural insulin produced by the body. The products based on insulin lispro are available in various forms: in the soluble form Humalog, fast-acting (more or less immediately after injection), and in the form Humalog NPL, a suspension with protamine that is absorbed more slowly during the day; the action in this case is prolonged. Humalog Mix combines these two formulations.
The replacement insulin acts like the insulin naturally produced by the body, facilitating the penetration of glucose contained in the blood into the cells. By controlling the level of sugar in the blood, the symptoms and complications of diabetes are reduced.
How has Humalog - Insulin lispro been studied?
Humalog was initially the subject of eight clinical studies involving 2951 patients with type 1 or 2 diabetes. The efficacy of Humalog was compared with that of Humulin R (human insulin in a recombinant DNA form) when added to one or two daily doses of long-acting insulins. Studies have measured the level of a substance in the blood, glycosylated hemoglobin (HbA1c), which gives an indication of the efficacy of blood glucose control, and fasting glucose levels. Other studies have been conducted on the use of Humalog in 542 children and adolescents (aged 2 to 19 years) and in the use of Humalog in combination with sulfonylureas (anti-diabetes medicines taken by mouth).
What benefit has Humalog - Insulin lispro shown during the studies?
Based on glycosylated hemoglobin and fasting glucose levels, no statistically significant differences were found between Humalog and Humulin in diabetes control.
What are the risks associated with Humalog - Insulin lispro?
Humalog can cause hypoglycaemia, which is a low level of glucose in the blood. For the full list of all side effects reported with Humalog, see the Package Leaflet.
Humalog should not be used in patients who may be allergic to any of the ingredients. It may also be necessary to adapt Humalog doses when administered together with other medicines that could affect blood sugar; for the complete list, see the package insert.
Under no circumstances may Humalog Mix and Humalog NPL be administered intravenously.
Why has Humalog - Insulin lispro been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Humalog's benefits are greater than its risks for diabetes mellitus treatment and therefore recommended that Humalog be given marketing authorization.
More information about Humalog - Insulin lispro
On 30 April 1996, the European Commission issued a marketing authorization valid throughout the European Union for Humalog to Eli Lilly Netherland BV. The marketing authorization was renewed on 30 April 2001.
For the full version of the evaluation (EPAR) of Humalog, click here.
Last update of this summary: 01-2006
