Lyumjev is also known as insulin lispro-aabc injection. Humalog is also known as insulin lispro injection.
Lyumjev is a fast-acting insulin. Lyumjev is used to control high blood sugar in adults 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 are available only with a prescription.
Lyumjev comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). The Lyumjev U-200 prefilled pen contains 2 times as much insulin per 1 milliliter as standard (U-100) insulin. 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 Lyumjev is safe and effective for children. 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 Lyumjev or Humalog or any of their ingredients.

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 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.
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
Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.
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.
High blood sugar and ketoacidosis for Humalog insulin pump users. You can have these serious problems when your insulin pump or infusion set stops working. They can also happen if your insulin is no longer effective. For these reasons, always keep extra insulin injection supplies with you.

Common side effects

The most common side effects of Lyumjev and Humalog are:

low blood sugar
reactions where you have injected insulin
itching
weight gain

allergic reactions
skin thickening or pits at the injection 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 re-use 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.

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
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

For more information, call 1-800-545-5979 or go to www.Lyumjev.com or www.humalog.com

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 health care 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.

Lyumjev^™ is a trademark and Humalog^® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

UR HI CON BS 15JUN2020