LYUMJEV

First assessment.

Favourable opinion for reimbursement in the treatment of diabetes mellitus in adults.

What therapeutic improvement?

No clinical added value compared to HUMALOG (insulin lispro).

Role in the care pathway?

In the management of type 1 diabetes in adults, the fast-acting insulin analogue may be used in a basal-bolus regimen, in combination with a long-acting insulin.

In the management of type 2 diabetes in adults, when initiating insulin therapy, it is recommended, in addition to monotherapy or dual therapy, to start:

• with an intermediate-acting insulin (NPH) at bedtime, preferably;
• or with a long-acting insulin analogue if the risk of nocturnal hypoglycaemia is a concern.

If the blood glucose target is not achieved despite the introduction of insulin therapy, the latter should be intensified. The different regimens possible are:

• a basal-bolus regimen
• a regimen with 1 to 3 daily injections of biphasic insulin.

In the event of very poor diabetes control, with repeated blood glucose levels above 3 g/L and/or an HbA1c level of more than 10%, an intensified insulin dosing regimen may be initiated from the outset following the opinion of an endocrinologist.

Role of the medicinal product in the care pathway

LYUMJEV (insulin lispro) is one of the recommended treatments in insulin-dependent diabetics requiring the administration of fast-acting insulin to control postprandial glucose levels, using a multiple-injection regimen (in combination with basal insulin) or insulin pump:

• in type 1 diabetes, LYUMJEV (insulin lispro) is a first-line treatment.
• in type 2 diabetes, LYUMJEV (insulin lispro) is a last-line treatment in a context of insulin therapy intensification.

The SPC for LYUMJEV (insulin lispro) does not contraindicate its use in pregnant women and studies have not demonstrated any systemic absorption of treprostinil, included as an excipient in the composition of LYUMJEV (insulin lispro); however, the precautionary principle should nonetheless be applied in women of childbearing potential, insofar as other available insulins do not contain this excipient and there is significant experience of their use.

The name LYUMJEV (insulin lispro) “Junior KwikPen”, enabling the dose to be adjusted in steps of 0.5 units, may be a source of confusion, suggesting the possibility of use in paediatric patients, whereas LYUMJEV (insulin lispro) is only indicated in adults, in contrast with HUMALOG (insulin lispro), for which the same name exists, which has an indication in children.

The existence of pens with 2 different dosages of the same insulin, as is the case for LYUMJEV (insulin lispro) and other insulins on the market (HUMALOG (insulin lispro) in particular), is a potential source of confusion and administration errors, for both patients and healthcare professionals, and such errors may have serious consequences, particularly in the event of insulin overdose.