Accessibility Statement

Lyumjev® (insulin lispro-aabc) Injection Approved by U.S. FDA for Children with Diabetes

The U.S. Food and Drug Administration (FDA) approved an expansion of the indication for Eli Lilly and Company's rapid-acting mealtime insulin Lyumjev® (insulin lispro-aabc) injection to include the improvement of glycemic control in children with diabetes. Lyumjev can be administered subcutaneously either at the start of a meal or within 20 minutes after starting a meal, or as a continuous subcutaneous insulin infusion (CSII) with an insulin pump.

The FDA approval was based on results from PRONTO-Peds, a phase 3, randomized, treat-to-target study that evaluated Lyumjev (100 units/mL) dosed at mealtime and post-mealtime (up to 20 minutes after the start of a meal) compared to Humalog® (insulin lispro) injection 100 units/mL in children and adolescents with diabetes. The study met the primary endpoint of noninferior A1C change from baseline to week 26 of Lyumjev compared to Humalog, both dosed at mealtime.1

Lyumjev was first approved by the FDA in June 2020 to improve glycemic control in adults with type 1 and type 2 diabetes and an expanded label was approved in August 2021 to include administration via CSII with an insulin pump. Lyumjev is available for adults in several global markets, including the U.S., EU and Japan. Additionally, on October 13, 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to extend the indication of Lyumjev for the treatment of children with diabetes aged 1 year and older on – an important step toward European approval.

Lilly offers several options to help eligible people who need assistance affording their Lilly insulin, including Lyumjev, at the Lilly Diabetes Solution Center at 1-833-808-1234  and People who have commercial insurance can visit to access the Lyumjev Savings Card. Lyumjev is also included in the Lilly Insulin Value Program for people with commercial insurance or no insurance at all, as well as in the Seniors Savings Model for people in the Medicare Part D program—allowing them to fill their monthly prescription of Lyumjev for $35. Other restrictions may apply.

Lyumjev is available in two strengths: U-100 (100 units/mL) and U-200 (200 units/mL).

For more information about Lyumjev, please visit

Download the brand logo.

Diabetes management is difficult at any age, but it can understandably be especially challenging for children. For the estimated 283,000 Americans aged 19 or younger who have been diagnosed with diabetes, many of whom may struggle to keep their blood glucose levels in their target range, it’s important to have a rapid-acting insulin option to meet their evolving needs to control high blood sugar. With its fast onset, Lyumjev is a meaningful option for people who rely on insulin to help improve their glycemic control, and we look forward to providing children in the U.S. with this important treatment option.

Paul OwensHead of Global Brand Development, Insulins, Glucagon & Devices, Lilly


Lyumjev® (LOOM-jehv) and Humalog® (HU-ma-log)

  • Lyumjev is a fast-acting insulin used to control high blood sugar in adults and children with diabetes. Humalog is a fast-acting insulin. Humalog is used to control high blood sugar in adults and children with diabetes.

  • Lyumjev comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). Lyumjev U-200 contains 2 times as much insulin in 1 milliliter as Lyumjev U-100. Humalog U-100 contains 100 units of insulin per milliliter. The dose window of the pen shows the number of insulin units to be delivered.

  • It is not known if Humalog is safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes as there were no studies done with Humalog in these groups of children. If your doctor decides to give your child any insulin products, he or she may give you special instructions.

All Lyumjev and Humalog products contain insulin lispro.

Warnings - Do not take Lyumjev or Humalog if you have:

  • symptoms of low blood sugar (hypoglycemia)

  • an allergy to insulin lispro-aabc, Humalog, or any of the ingredients in Lyumjev or Humalog.

Do not reuse needles or share your insulin injection supplies with other people. This includes your:

  • prefilled pen for use by a single patient

  • cartridges

  • reusable pen that works with Lilly 3mL cartridges available for Humalog

  • needles

  • syringes

You or the other person can get a serious infection. This can happen even if you change the needle.

Do not change the type of insulin you take or your dose unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.

Do not use a syringe to remove Lyumjev or Humalog from your prefilled pen. This can cause you to take too much insulin. Taking too much insulin can lead to severe low blood sugar. This may result in seizures or death.

Lyumjev and Humalog may cause serious side effects. Some of these can lead to death. The possible serious side effects are:

  • Low blood sugar. This can cause:

    • dizziness or lightheadedness

    • sweating

    • confusion

    • headache

    • blurred vision

    • slurred speech

    • shakiness

    • fast heartbeat

    • anxiety

    • irritability

    • mood change

    • hunger

If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. These are used when your blood sugar becomes too low and you are unable to take sugar by mouth. Glucagon helps your body release sugar into your bloodstream.

  • Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.

  • Severe allergic reaction. Get emergency help right away if you have:

    • a rash over your whole body

    • trouble breathing

    • a fast heartbeat

    • sweating

    • a faint feeling

    • shortness of breath

    • extreme drowsiness

    • dizziness

    • confusion

    • swelling of your face, tongue, or throat

  • Heart failure. Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or “TZDs,” with Lyumjev or Humalog may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with Lyumjev or Humalog. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. Some symptoms of heart failure include shortness of breath, swelling of ankles and feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.

  • Sudden onset of high blood sugar and high amounts of ketones in your blood or urine. You can have these serious side effects when your insulin pump or infusion set is not working the right way, if there are handling errors, or if your insulin is no longer effective. For these reasons, you may not get the right amount of insulin, so always keep extra insulin and injection supplies with you.

Common side effects

The most common side effects of Lyumjev and Humalog are:

  • low blood sugar

  • allergic reactions

  • reactions or pain at the injection or infusion site with insulin pump use

  • skin thickening or pits at the injection or infusion site

  • itching

  • rash

  • weight gain

Other most common side effects with Humalog include swelling of your hands or feet.

These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or

Before using

Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:

  • about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.

  • about any other prescription medicines you take, especially ones called TZDs.

  • about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems.

  • if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed.

How to take

Read the Instructions for Use that come with your Lyumjev or Humalog. Be sure to take your Lyumjev or Humalog and check your blood sugar levels exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or physical activity level. He or she may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.

Before injecting your Lyumjev or Humalog

You can inject your insulin dose yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:

  • Check the insulin label before each injection. This will help you make sure that you are taking the correct insulin.

  • Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you reuse needles.

  • Change (rotate) where you inject your insulin with each dose. This can reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.

  • Monitor injection and infusion sites closely when initiating therapy with Lyumjev in children. Contact a healthcare provider if persistent injection or infusion site reactions occur.

When you are ready to inject

  • Inject Lyumjev under your skin at the beginning of a meal or within 20 minutes after you start eating a meal.

  • Inject Humalog under your skin within 15 minutes before or right after you eat a meal.

Staying safe while taking your Lyumjev or Humalog

To stay safe while taking your insulin, be sure to never inject Lyumjev U-200 in your vein, muscle, or with an insulin pump. Also be sure not to:

  • mix Lyumjev with other insulins or liquids

  • drive or use heavy machinery until you know how your Lyumjev or Humalog affects you.

  • drink alcohol or use other medicines that contain alcohol when taking your Lyumjev or Humalog.

Learn more

Lyumjev and Humalog are prescription medicines. For more information, call 1-800-545-5979 or go to or

This summary provides basic information about Lyumjev and Humalog. It does not include all information known about these medicines. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about your insulin lispro product and how to take it. Your doctor is the best person to help you decide if these medicines are right for you.

Please see Lyumjev Full Prescribing Informationincluding Patient Prescribing Information

Please see Humalog Full Prescribing Information including Patient Prescribing Information


Lyumjev® and Humalog® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.


  1. Wadwa, RP, Laffel, LM, Franco, DR, Dellva, MA, Knights, AW, Pollom, RK. Efficacy and safety of ultra-rapid lispro versus lispro in children and adolescents with type 1 diabetes: The PRONTO-Peds trial. Diabetes Obes Metab. 2022; 1- 9. doi:10.1111/dom.14849

PP-UR-US-0819 10/2022 ©Lilly USA, LLC. 2022. All rights reserved.