Lyumjev (previously Liumjev) | European Medicines Agency (EMA)

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Overview

Lyumjev is a medicine used to control blood glucose (sugar) levels in adults and children aged 1 year and above with diabetes. It contains the active substance insulin lispro.

Lyumjev can only be obtained with a prescription. It is given as an injection under the skin of the upper arm, thigh, buttock or belly. It can also be given with an insulin pump. A healthcare professional should explain to the patient how to use the medicine properly.

Because Lyumjev is a fast-acting insulin, it is usually given just before a meal or, if more appropriate, soon after a meal. The dose of Lyumjev is worked out for each patient and depends on the patient’s blood glucose level.

In some circumstances, such as when blood acid levels are dangerously high (ketoacidosis), Lyumjev may be given into a vein, under a doctor’s supervision.

For more information about using Lyumjev, see the package leaflet or contact your doctor or pharmacist.

In diabetes, patients have high levels of blood glucose either because the body does not produce enough insulin, or the body is unable to use insulin effectively.

The active substance in Lyumjev is a form of insulin that acts faster than regular human insulin or standard insulin lispro medicines because it is absorbed more quickly by the body. It helps control blood glucose levels, thereby alleviating symptoms and reducing the risk of complications of diabetes.

Lyumjev has been shown to be as good at controlling blood glucose as another insulin lispro medicine, Humalog, in four main studies.

Two of the studies involved adults whose diabetes treatment already required injection of mealtime insulin, one involving 1,222 patients with type 1 diabetes (where the body cannot make its own insulin) and one in 673 patients with type 2 diabetes (where the body cannot make enough insulin or cannot use it effectively). The main measure of effectiveness was the HbA1c percentage: lower HbA1c marks well-controlled blood glucose. The average starting HbA1c in both studies was 7.3%. Over 6 months of treatment, patients with type 1 diabetes experienced a fall of 0.13 percentage points in HbA1c with Lyumjev and 0.05 percentage points with Humalog. In patients with type 2 disease, HbA1c fell by 0.38 percentage points with Lyumjev and 0.43 percentage points with Humalog.

The third, smaller, study involved 49 adults whose diabetes was managed with an insulin pump and indicated that both Lyumjev and Humalog were effective in maintaining control of blood sugar in this setting.

A fourth study involving 716 children aged 3 years and above with type 1 diabetes also showed that Lyumjev was at least as effective as Humalog in maintaining control of blood sugar.

The most common side effect with Lyumjev (which may affect more than 1 in 10 people) is hypoglycaemia (low blood glucose).

Lyumjev must not be given to people whose blood glucose level is already low. Doses may need to be adjusted when it is given with other medicines that reduce blood glucose.

For the full list of side effects and restrictions of Lyumjev, see the package leaflet.

Lyumjev has been shown to be effective in controlling blood sugar, and because its action begins faster than existing insulin lispro medicines it was particularly useful in reducing the rise in blood glucose after a meal, although side effects such as low blood sugar might also develop more quickly.

The main studies looked at adults with type 1 and type 2 diabetes as well as children from 3 years of age with type 1 diabetes. The European Medicines Agency noted that these studies were sufficient to show that the medicine will be effective in younger children (from 1 year of age) with type 1 or type 2 diabetes.

The Agency therefore decided that Lyumjev’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lyumjev have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Lyumjev are continuously monitored. Side effects reported with Lyumjev are carefully evaluated and any necessary action taken to protect patients.

Liumjev received a marketing authorisation valid throughout the EU on 24 March 2020.

The name of the medicine was changed to Lyumjev on 21 April 2021.

English (EN)
(133.53 KB – PDF)

First published: 16/04/2020Last updated: 25/04/2023

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English (EN)
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First published: 16/04/2020

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Product information

English (EN)
(2.41 MB – PDF)

First published: 16/04/2020Last updated: 14/02/2025

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Latest procedure affecting product information:
R/0019

13/01/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(60.01 KB – PDF)

First published: 16/04/2020Last updated: 25/04/2023

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Product details

Name of medicine: Lyumjev (previously Liumjev)
Active substance: insulin lispro
International non-proprietary name (INN) or common name: insulin lispro
Therapeutic area (MeSH): Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code: A10AB04

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Treatment of diabetes mellitus in adults.

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