What is Humalog - Insulin lispro?
Humalog comprises a range of injectable solutions and suspensions supplied in vials, cartridges and pre-filled pens (Humalog Pen, Humaject). The active substance is insulin lispro. The Humalog series includes fast-acting insulin solutions (Humalog), long-acting insulin suspensions (Humalog NPL) and combinations of both in various proportions (Humalog Mix):
Humalog: lispro insulin 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 - Insulin lispro?
Humalog is used to treat adults and children with diabetes mellitus who require insulin to control their 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 given by subcutaneous injection (under the skin) in the upper arm, thigh, buttocks or abdomen (belly). Humalog can also be given by continuous subcutaneous infusion by pump. insulin or intravenously. Humalog and Humalog Mix are usually given shortly before meals and possibly immediately after meals. Humalog can be used in combination with a long-acting insulin or anti-diabetic medicines taken by mouth (sulphonylureas). Humalog NPL can be mixed or taken with Humalog.
How does Humalog - Insulin lispro work?
Diabetes is a disease where the body does not make enough insulin to control the level of sugar in the blood. Humalog is a replacement insulin that is very similar to the insulin produced by the pancreas. The active substance in Humalog is insulin lispro, which is produced by so-called 'recombinant DNA' technology. This technique uses a bacterium into which a gene (DNA) is inserted which makes it capable of producing insulin lispro. Insulin lispro differs very little from the insulin produced by the human body, it is also absorbed more quickly by the body, so it can act more quickly than the natural insulin produced by the body. Insulin lispro products are available in various forms: in the soluble form Humalog, which is fast acting (more or less immediately after injection), and in the form Humalog NPL, a suspension with protamine which is absorbed more slowly during the course of the day; the action in this case is prolonged. Humalog Mix combines these two formulations.
The replacement insulin acts like the insulin produced naturally by the body, facilitating the penetration of the 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 been studied - Insulin lispro?
Humalog was initially the subject of eight clinical studies involving 2951 patients with type 1 or type 2 diabetes. The efficacy of Humalog was compared to that of Humulin R (human insulin in soluble form from recombinant DNA) when added to one or two daily doses of long-acting insulins. The studies measured the level in the blood of a substance, glycosylated hemoglobin (HbA1c), which gives an "indication of how well the blood glucose is controlled, and the levels of glucose a fast. Other studies have been conducted on the use of Humalog in 542 children and adolescents (aged 2 to 19 years) and on the use of Humalog in combination with sulphonylureas (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 the control of diabetes.
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 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. The doses of Humalog may also need to be adjusted when given together with other medicines which may affect the sugar in the blood; for the complete list, see the package leaflet.
Under no circumstances can 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 in the treatment of diabetes mellitus and therefore recommended that Humalog be given a Marketing Authorization.
More information about Humalog - Insulin lispro
On 30 April 1996 the European Commission issued Eli Lilly Netherland B.V. a "Marketing Authorization" for Humalog, valid throughout the European Union. The "Marketing Authorization" was renewed on April 30, 2001.
For the full version of the evaluation (EPAR) of Humalog, click here.
Last update of this summary: 01-2006
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