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Lyumjev

Generic name: insulin lispro-aabc

What is Lyumjev?

  • Lyumjev is a man-made fast-acting insulin used to control high blood sugar in adults with diabetes mellitus.
  • It is not known if Lyumjev is safe and effective in children.

What is the most important information I should know about Lyumjev?

Do not share your Lyumjev with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.

Who should not take Lyumjev?

Do not take Lyumjev if you:

  • are having an episode of low blood sugar (hypoglycemia).
  • have an allergy to Lyumjev or any of the ingredients in Lyumjev. See the end of this Patient Information guide for a complete list of ingredients in Lyumjev.

What should I tell my healthcare provider before taking Lyumjev?

Before taking Lyumjev, tell your healthcare provider about all of your medical conditions, including if you:

  • have kidney or liver problems.
  • take any other medicines, especially ones called thiazolidinediones (TZDs).
  • have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Lyumjev.
  • are pregnant or plan to become pregnant. Talk with your healthcare provider about the best way to control your blood sugar if you plan to become pregnant or while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if Lyumjev passes into your breast milk. You and your healthcare provider should decide if you will take Lyumjev while you breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Before you start taking Lyumjev, talk to your healthcare provider about low blood sugar and how to manage it.

How should I take Lyumjev?

  • Read the Instructions for Use that come with your Lyumjev.
  • Take Lyumjev exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much Lyumjev to take and when to take it.
  • Lyumjev starts acting fast. Inject Lyumjev at the beginning of a meal or within 20 minutes after you start eating a meal.
  • Know the type and strength of insulin you take. Do not change the type or amount of insulin you take unless your healthcare provider tells you to. The amount of insulin and the best time for you to take your insulin may need to change if you take different types of insulin.
  • Check your insulin label each time you give your injection to make sure you are using the correct insulin.
  • Check your blood sugar levels. Ask your healthcare provider what your blood sugars should be and when you should check your blood sugar level.
  • Lyumjev comes in U-100 (100 units/mL) and U-200 (200 units/mL) insulin strengths.
  • Lyumjev U-200 contains 2 times as much insulin (200 units/mL) in 1 mL as the standard insulin (100 units/mL).
  • Lyumjev U-100 and Lyumjev U-200 can be injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms.
  • Lyumjev U-100 can also be given in your vein (intravenously) by your healthcare provider. Lyumjev U-200 cannot be given in your vein.
  • Change (rotate) your injection sites within the area you choose with each dose to reduce your risk of getting pits in skin or thickened skin (lipodystrophy) and skin with lumps (localized cutaneous amyloidosis) at the injection sites.
    • Do not use the exact same spot for each injection.
    • Do not inject where the skin has pits, is thickened, or has lumps.
    • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.
  • If you miss a dose of Lyumjev, monitor your blood sugar levels to decide if an insulin dose is needed. Continue with your regular dosing schedule at the next meal.
  • Lyumjev comes in a vial, single-patient-use prefilled pen, or in a cartridge. Do not use a syringe to remove Lyumjev from your single-patient-use prefilled pen or cartridge.

Keep Lyumjev and all medicines out of the reach of children.

Your dose of Lyumjev may need to change because of: a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of other medicines you take.

What should I avoid while taking Lyumjev?

While taking Lyumjev do not:

  • drive or operate heavy machinery, until you know how Lyumjev affects you.
  • drink alcohol or take other medicines that contain alcohol.

What are the possible side effects of Lyumjev?

Lyumjev may cause serious side effects that can lead to death, including:

  • low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include:
    • dizziness or light-headedness,
    • sweating,
    • confusion,
    • headache,
    • blurred vision,
    • slurred speech,
    • shakiness,
    • fast heartbeat,
    • hunger,
    • anxiety,
    • irritability, or
    • mood changes.
  • low potassium in your blood (hypokalemia).
  • serious allergic reactions (whole body allergic reaction). Get emergency medical help right away, if you have any of these symptoms of a severe allergic reaction:
    • a rash over your whole body,
    • trouble breathing,
    • a fast heartbeat,
    • swelling of your face, tongue, or throat, sweating, or
    • feeling faint.
  • heart failure. Taking certain diabetes pills called thiazolidinediones (TZDs) with Lyumjev may cause heart failure in some people. This can happen even if you have never had heart failure or heart failure problems before. If you already have heart failure it may get worse while you take TZDs with Lyumjev. Your healthcare provider should monitor you closely while you are taking TZDs with Lyumjev. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath, swelling of your ankles or feet, or sudden weight gain. Treatment with TZDs and Lyumjev may need to be adjusted or stopped by your healthcare provider if you have new or worse heart failure.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, swelling of you face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

The most common side effects of Lyumjev include:

  • low blood sugar (hypoglycemia), reactions at the injection site, allergic reactions, rash, itching (pruritus), thickening or pits at the injection site (lipodystrophy), and weight gain.

These are not all the possible side effects of Lyumjev. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Lyumjev

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not take Lyumjev for a condition for which it was not prescribed. Do not give Lyumjev to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about Lyumjev that is written for health professionals.

How should I store Lyumjev?

Vials

All not in-use (unopened) vials:

  • Store all not in-use (unopened) vials in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze. Do not use if Lyumjev has been frozen.
  • Keep away from direct heat and light.
  • Not in-use (unopened) vials can be used until the expiration date on the carton and label, if they have been stored in the refrigerator.
  • Not in-use (unopened) vials should be thrown away after 28 days, if they are stored at room temperature.

After vials have been in-use (opened):

  • Store in-use (opened) vials in the refrigerator or at room temperature below 86°F (30°C) for up to 28 days.
  • Keep vials away from direct heat and light.
  • Throw away all in-use (opened) vials after 28 days of use, even if there is insulin left in the vial.

Keep Lyumjev vials, syringes, needles and all medicines out of the sight and reach of children.

KwikPen

Unused Pens

  • Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze Lyumjev. Do not use if it has been frozen.
  • Unused Pens may be used until the expiration date printed on the label if the Pen has been kept in the refrigerator.

In-use Pen

  • Store the Pen you are currently using at room temperature [up to 86°F (30°C)]. Keep away from heat and light.
  • Throw away the Lyumjev KwikPen you are using after 28 days, even if it still has insulin left in it.

Junior KwikPen

Unused Pens

  • Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze Lyumjev. Do not use if it has been frozen.
  • Unused Pens may be used until the expiration date printed on the label if the Pen has been kept in the refrigerator.

In-use Pen

  • Store the Pen you are currently using at room temperature [up to 86°F (30°C)]. Keep away from heat and light.
  • Throw away the Lyumjev Junior KwikPen you are using after 28 days, even if it still has insulin left in it.

Tempo Pen

Unused Pens

  • Store unused Pens in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Do not freeze Lyumjev. Do not use if it has been frozen.
  • Unused Pens may be used until the expiration date printed on the label if the Pen has been kept in the refrigerator.

In-use Pen

  • Store the Pen you are currently using at room temperature [up to 86°F (30°C)]. Keep away from heat and light.
  • Throw away the Lyumjev Tempo Pen you are using after 28 days, even if it still has insulin left in it.

What are the ingredients in Lyumjev?

Active ingredient: insulin lispro-aabc

Inactive ingredients: glycerol, magnesium chloride hexahydrate, metacresol, sodium citrate dihydrate, treprostinil sodium, zinc oxide (zinc ion), and Water for Injection, USP

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

Source: National Library of Medicine. Last updated June 15, 2020.