Mother and daughter packing a lunch together in the kitchen

Patient portrayal.

Welcome to Lyumjev

Lyumjev is a rapid-acting insulin used to treat adults and children with diabetes for the control of high blood sugar.

Lyumjev (pronounced LOOM-jehv)

In adults with diabetes, Lyumjev,

Helps to provide proven A1C reduction in type 1 and type 2 diabetes
Is a mealtime insulin that is designed to reduce blood sugar spikes that happen naturally after a meal
Controls after-meal blood sugar, similar to how natural insulin works after meals in people without diabetes^1-3

In children with diabetes, Lyumjev helps control high blood sugar

Lyumjev can be given with a KwikPen^®, a vial and syringe, or an insulin pump. Lyumjev is also available in a Tempo Pen^™.

Lyumjev U-200 cannot be given by an insulin pump.
Check your insulin pump’s user manual to see if it can be used with Lyumjev U-100. Follow the instructions in your pump’s user guide when taking Lyumjev.

Patient portrayal.

Mealtime and long-acting insulins help keep your blood sugar in control⁴

When you have diabetes, your body is not able to effectively make or use insulin it needs to control blood sugar levels.⁵

Long-acting insulin, also known as basal insulin, works throughout the day and night to help bring down your blood sugar levels in between your meals.⁴

Fast-acting insulins are also known as mealtime insulins. They enter the bloodstream and work in your body quickly in order to help control blood sugar levels. Fast-acting insulins work quickly and are taken with meals.⁴

Mealtime insulin helps control blood sugar after you eat and works with long-acting insulin to help keep your blood sugars at recommended levels throughout the day.⁴

Designed to reduce your after-meal sugar spikes

Lyumjev is a fast-acting mealtime insulin that works to help control blood sugar spikes after you eat, similar to how natural insulin works after meals in people without diabetes.^1-3

SELECT SAFETY INFORMATION

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.

Patient portrayal.

Already on a mealtime insulin?

Lyumjev is a formulation of insulin lispro designed to be absorbed quickly in your body^*6,7

^*Lyumjev contains additional ingredients compared with Humalog^®(insulin lispro).

Lyumjev starts lowering blood sugar faster than Humalog.^8,9

In adult studies:

Type 1 study: 20 minutes (Lyumjev) vs 31 minutes (Humalog) ⁸
Type 2 study: 32 minutes (Lyumjev) vs 45 minutes (Humalog) ⁹

In clinical studies, Lyumjev reduced blood sugar spikes better than Humalog 1 and 2 hours after meals.^10,11

Because Lyumjev works fast, you should take it at the start of your meal or within 20 minutes after you start eating a meal.

SELECT SAFETY INFORMATION

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.

How should I take Lyumjev?

Lyumjev starts working fast. Take it at the start of your meal or within 20 minutes after you start eating to reduce your blood sugar.

Woman in orange blazer enjoying coffee at a table alone

Patient portrayal.

Methods of Administration

Lyumjev can be given with a KwikPen^®, a vial and syringe, or an insulin pump, just like Humalog^® (insulin lispro) injection, 100 units/mL. Lyumjev is also available in a Tempo Pen^™.

Lyumjev U-200 cannot be given by an insulin pump.
Check your insulin pump's user manual to see if it can be used with Lyumjev U-100. Follow the instructions in your pump's user guide when taking Lyumjev.

Be sure to take your insulin 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. They may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.^1,12

SELECT SAFETY INFORMATION

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 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.

How to inject using the Lyumjev KwikPen

Please read the step-by-step instructions that come with your device for more complete directions.

Prepare your pen

Make sure you have the right insulin
Pull the Pen cap off. Wipe the rubber seal with alcohol
Remove the paper tab from the Pen needle
Put a new needle onto the Pen and twist it until it is tight
Pull off the outer shield. Do not throw it away
Pull off the inner shield. Throw it away

Prime your pen

Turn the dose knob to 2 units
Hold the Pen with the needle pointing up and tap gently
Then push the dose knob until it stops and you see “0” in the dose window
Count to “5” slowly. You should see insulin at the tip of the needle. If you do not see insulin, repeat the priming steps, but no more than 4 times

Select your dose

Turn the dose knob until the number of units you need to inject appears in the window

Give your injection

Pick a spot to inject—belly, upper legs, upper arms, or buttocks. Choose a different spot each time you inject to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites.^1,12
Wipe your skin with alcohol and let it dry
When you’re ready, put the needle straight in, then push the dose knob until it stops. Count to “5” slowly
Pull the needle out of your skin
Make sure there is a “0” in the window

Clean up

Put the outer needle shield back on the needle
Unscrew the used needle from the Pen and put it in a sharps container
Recap the Pen. Store your Pen at room temperature (up to 86 °F or 30 °C)
In-use Pen: Throw away the Pen you are using after 28 days, even if it still has insulin left in it

See links below for more information on:

SELECT SAFETY INFORMATION

Do not use a syringe to remove Lyumjev 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.

Using Lyumjev with a Tempo Pen^™

The Tempo Pen functions in a similar way to the prefilled insulin KwikPen^® and is modified to work with the Tempo Smart Button^™.

The Tempo^™ Personalized Diabetes Management Platform is designed to assist you in the self-management of your diabetes. Tempo brings your information into one place, which may help you and your healthcare professional make decisions about your treatment.

Warning: The Tempo Personalized Diabetes Management Platform is intended to help support the management of your diabetes. You must continue to independently manage your glucose values and your prescribed regimen with support from your healthcare practitioner.

The actual pen color and the physical pen many vary from the illustration based on insulin brand used. Smartphone not included with the Tempo Personalized Diabetes Management Platform.

Learn more about the Tempo Personalized Diabetes Management Platform

How to administer Lyumjev U-100 using an insulin pump

Lyumjev is a fast-acting insulin used to treat adults and children with diabetes for the control of high blood sugar.

Important considerations when taking Lyumjev U-100 in a pump:

Use your pump and insulin exactly as your doctor tells you to and according to the user manual. Check your pump’s instructions to make sure it can be used with Lyumjev U-100.
Change the Lyumjev in your pump reservoir according to the pump’s instructions even if you haven’t used all the insulin. Throw insulin away if exposed to temperatures higher than 98.6 °F (37 °C).
Change infusion sets and choose your infusion site according to your pump’s instructions. Rotate sites to reduce your chance of getting pits, lumps, or thickened skin and don’t place your set into thickened, tender, bruised, scaly, hard, scarred, or damaged skin. Change your site and tell your doctor if the skin around your site becomes red, itchy, pitted, lumpy, or thickened.
Pump malfunctions, infusion site issues, or insulin that is no longer effective can cause high blood sugar and ketoacidosis (buildup of ketones in the body). Pump malfunctions can also cause low blood sugar. Talk to your doctor about when to switch to insulin injections if these issues can’t be resolved quickly.
Do not use Lyumjev U-200 in an insulin pump. Do not mix Lyumjev with other insulins or liquids.

Read the full Instructions for Use that came with your Lyumjev for more information.

If you have additional questions, give us a call at 1-800-LillyRx (1-800-545-5979).

SELECT SAFETY INFORMATION

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

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, or if there are handling errors. For these reasons, you may not get the right amount of insulin, so always keep extra insulin and injection supplies with you.

If you use insulin in a pump, talk to your healthcare provider about infusion sites, including:¹³

Skin barriers or other treatments to prevent symptoms or offer relief if you experience infusion site reactions. With any insulin therapy, you may experience rash, redness, inflammation, pain, bruising, or itching at the infusion site

Whether you should consider changing your cannula length and/or type if you experience infusion site reactions

Rotating infusion sites to reduce your risk of getting pits, lumps, or thickened skin

Avoiding sites where the skin is tender or injured, or that may experience muscle movement or trauma

If you notice any irritation around your infusion site, tell your doctor.

Check your blood sugar levels regularly, especially when changing infusion sites. Ask your doctor what your blood sugar levels should be and when you should check your blood sugar.

Always follow your insulin pump's instructions, as well as the instructions that come with your insulin, for specific information about using it in a pump. Always use your insulin and pump exactly as your doctor tells you to.

Prefer to take your Lyumjev another way?

Lyumjev U-100 is also available in a vial and can be given with a U-100 insulin syringe.

Click here to learn how to use a vial and syringe for Lyumjev U-100.

If your doctor has prescribed Lyumjev U-200 for you, click here to learn how to use the Lyumjev U-200 KwikPen.

References

Lyumjev. Prescribing Information. Indianapolis, IN: Lilly USA, LLC.
Ramchandani N, Ellis MK, Jain S, et al. Basal insulin requirements on continuous subcutaneous insulin infusion during the first 12 months after diagnosis of type 1 diabetes mellitus. J Diabetes Sci Technol. 2010;4(3):610-614. doi:10.1177/193229681000400315.
Sanlioglu AD, Altunbas HA, Balci MK, Griffith TS, Sanlioglu S. Clinical utility of insulin and insulin analogs. Islets. 2013;5(2):67-78. doi:10.4161/isl.24590.
Horton ES. Defining the role of basal and prandial insulin for optimal glycemic control. J Am Coll Cardiol. 2009; 53(5 suppl):S21-S27. doi:10.1016/j.jacc.2008.11.008
American Diabetes Association website. Insulin Basics for Diabetes.https://diabetes.org/health-wellness/medication/insulin-basics. Accessed October 28, 2024.
Pratt E, Leohr J, Heilmann C, Johnson J, Landschulz W. Treprostinil causes local vasodilation, is well tolerated, and results in faster absorption of insulin lispro. Diabetes. 2017;66 (Suppl. 1 ):A253.
Paavola CD, Cox AL, Sperry AE, Hansen RJ, Li S, Bradley SA, et al. A stable, hexameric, ultra-rapid insulin formulation containing citrate. Diabetes. 2017;66 (Suppl. 1 ):A254.
Linnebjerg H, Zhang Q, LaBell E, et al. Pharmacokinetics and glucodynamics of ultra rapid lispro (URLi) versus Humalog® (lispro) in younger adults and elderly patients with type 1 diabetes mellitus: a randomized controlled trial. 2020;59(12):1589-1599. Clin Pharmacokinet. doi:10.1007/s40262-020-00903-0
Leohr J, Dellva MA, Coutant DE, et al. Pharmacokinetics and glucodynamics of ultra rapid lispro (URLi) versus Humalog® (lispro) in patients with type 2 diabetes mellitus: a phase I randomised, crossover study. 2020;59(12):1601-1610. Clin Pharmacokinet. doi:10.1007/s40262-020-00901-2
Klaff L, Cao D, Dellva MA, et al. Ultra Rapid Lispro Improves Postprandial Glucose Control Compared with Lispro in Patients With Type 1 Diabetes: Results from the 26-week PRONTO-T1D study. Diabetes Obes Metab. 2020. Doi:10 .11111 /dom .14100.
Data on File, Lilly USA, LLC, DOF-UR-US-0022.
Lyumjev. Patient Package Insert. Indianapolis, IN: Lilly USA, LLC
Insulin infusion sets troubleshooting guide. Association of Diabetes Care & Education Specialists; 2020. https://www.adces.org/docs/default-source/handouts/insulinrelated/handout_hcp_ir_troubleshootingguide.pdf?Status=Master&sfvrsn=4b346359_19. Accessed October 18, 2024.

INDICATION

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 and Humalog come in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). Lyumjev U-200 and Humalog U-200 contain 2 times as much insulin in 1 milliliter as standard (U-100) insulin. Lyumjev U-100 and Humalog U-100 contain 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.

SAFETY SUMMARY

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
- headache
- shakiness
- irritability
- sweating
- blurred vision
- fast heartbeat
- mood change
- confusion
- slurred speech
- anxiety
- hunger
If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon rescue medication. 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
- sweating
- extreme drowsiness
- swelling of your face, tongue, or throat
- trouble breathing
- a faint feeling
- dizziness
- a fast heartbeat
- shortness of breath
- confusion

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
reactions or pain at the injection or infusion site with insulin pump use
itching
weight gain

allergic reactions
skin thickening or pits at the injection or infusion site
rash

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 www.fda.gov/medwatch.

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 a meal 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 or Humalog U-200 in your vein, muscle, or with an insulin pump. Also be sure not to:

mix Lyumjev or Humalog 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.

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.

UR HI CON BS 11OCT2023

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

Welcome to Lyumjev

Lyumjev is a rapid-acting insulin used to treat adults and children with diabetes for the control of high blood sugar.

Lyumjev (pronounced LOOM-jehv)

Mealtime and long-acting insulins help keep your blood sugar in control4

Designed to reduce your after-meal sugar spikes

Insulin Affordability

Already on a mealtime insulin?

Lyumjev is a formulation of insulin lispro designed to be absorbed quickly in your body*6,7

How should I take Lyumjev?

Methods of Administration

How to inject using the Lyumjev KwikPen

Prepare your pen

Prime your pen

Select your dose

Give your injection

Clean up

See links below for more information on:

Using Lyumjev with a Tempo Pen™

The Tempo Pen functions in a similar way to the prefilled insulin KwikPen® and is modified to work with the Tempo Smart Button™.

How to administer Lyumjev U-100 using an insulin pump

If you use insulin in a pump, talk to your healthcare provider about infusion sites, including:13

Prefer to take your Lyumjev another way?

INDICATION

SAFETY SUMMARY

Warnings -

Common side effects

Before using

How to take

Learn more

Mealtime and long-acting insulins help keep your blood sugar in control⁴

Lyumjev is a formulation of insulin lispro designed to be absorbed quickly in your body^*6,7

Using Lyumjev with a Tempo Pen^™

The Tempo Pen functions in a similar way to the prefilled insulin KwikPen^® and is modified to work with the Tempo Smart Button^™.

If you use insulin in a pump, talk to your healthcare provider about infusion sites, including:¹³