Lyumjev ® ▼ (insulin lispro)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Lyumjev Summary of Product Characteristics (SmPC)

Lyumjev® ▼ (insulin lispro): Initiation of Therapy

Lyumjev is a mealtime insulin for SC injection and should be administered at the start of the meal, or up to 20 minutes after starting the meal. Treatment initiation can be done on unit-to-unit basis.

Initiation of Lyumjev Therapy

Indication

Treatment of diabetes mellitus in adults. 1

Lyumjev is a mealtime insulin for subcutaneous injection and should be administered zero to two minutes before the start of the meal, with the option to administer up to 20 minutes after starting the meal. 1

Lyumjev given by SC injection should generally be used in regimens with intermediate or long-acting insulin.1

Lyumjev Treatment Initiation in Phase 3 Studies: PRONTO-T1D and PRONTO-T2D

During the lead-in period in the PRONTO-T1D and PRONTO-T2D phase 3 studies, patients were treated with IL-100 as their prandial insulin. Patients treated with insulin aspart or insulin glulisine as their prestudy prandial insulin were transitioned to IL-100 on a unit-to-unit basis.2

When entering the intensive titration period in PRONTO-T1D and PRONTO-T2D phase 3 studies, patients were randomized to treatment with either Lyumjev or IL-100 on a unit-to-unit basis.2

In the phase 3 studies, based on clinical judgment, the study investigators were allowed to reduce prandial insulin doses by approximately 10% to 20%

  • in patients with fairly well-controlled HbA1c and SMBG levels, and

  • based on the patient's overall glycemic status or other considerations in order to reduce the risk of postprandial hypoglycemia.2

The early onset of action must be considered when prescribing URLi (LY900014). Continued adjustment of the dose of URLi (LY900014) should be based on the patient’s metabolic needs, blood glucose monitoring results, and glycaemic control goal. Dose adjustments may be needed, when switching from another insulin, with changes in physical activity, changes in concomitant medicinal products, changes in meal patterns (i.e., amount and type of food, timing of food intake), changes in renal or hepatic function or during acute illness to minimize the risk of hypoglycaemia or hyperglycaemia. 1

If converting from another mealtime insulin to URLi (LY900014), the change can be done on a unit-to-unit basis. The potency of insulin analogues, including URLi (LY900014), is expressed in units. One (1) unit of Lyumjev corresponds to 1 international unit (IU) of human insulin or 1 unit of other fast-acting insulin analogues. 1

References

1. Lyumjev [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

DM = diabetes mellitus

GC = glucose control

HbA1c = glycated hemoglobin

IL-100 = Humalog® (insulin lispro injection) 100 units/mL

PRONTO-T1D = a Prospective, Randomized, double-blind cOmparison of LY900014 to iNsulin lispro with an open-label postprandial LY900014 Treatment group, in cOmbination with insulin glargine or insulin degludec, in adults with Type 1 Diabetes

PRONTO-T2D = a Prospective, Randomized, double-blind cOmparison of LY900014 to iNsulin lispro, boTh in cOmbination with insulin glargine or insulin degludec in adults with Type 2 Diabetes

SC = subcutaneous

SMBG = self-monitored blood glucose

URLi = ultra rapid lispro

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Date of Last Review: February 04, 2020


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