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): Treprostinil Safety in Young Children

The safety of treprostinil in pediatric patients has not been established.

Detailed Information

The safety of treprostinil in pediatric patients has not been established.1

In animal studies conducted by Lilly, the offspring's early development was not affected by their exposure to treprostinil

  • during pregnancy, and

  • from milk consumed after birth.2

Treprostinil is as an excipient in Lyumjev and is unmeasurable in plasma with administration of clinically relevant doses of Lyumjev.3 Based on this, regulators have indicated that juvenile toxicity studies in animals are not required.2

References

1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corp.; 2018.

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

3. Michael MD, Zhang C, Siesky AM, et al. Exploration of the mechanism of accelerated absorption for a novel insulin lispro formulation [abstract]. Diabetes. 2017;66(suppl 1):A250. https://doi.org/10.2337/db17-890-1488

Glossary

Lilly = Eli Lilly and Company

treprostinil = Remodulin® (treprostinil) injection

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: June 18, 2018

Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 8am - 4pm, excluding Bank Holidays

Or you can

Ask us a question Chat with Us If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a question