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:
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.
- dizziness or lightheadedness
- headache
- shakiness
- irritability
- sweating
- blurred vision
- fast heartbeat
- mood change
- confusion
- slurred speech
- anxiety
- hunger
- 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 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.
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 14OCT2022
Lyumjev® and Humalog® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.