Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Lyumjev is a man-made fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.

Lyumjev is used to improve blood sugar control in adults and children with diabetes mellitus.

Never share an injection pen, cartridge, or syringe with another person, even if the needle has been changed.

Use Lyumjev exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Read the Instructions for Use leaflet that comes with your prescription.

Lyumjev starts acting fast. Inject Lyumjev at the beginning of a meal or within 20 minutes after you start eating a meal. 

Lyumjev is injected under the skin with a syringe and needle or an injection pen (KwikPen, Junior KwikPen or Tempo Pen).

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 Lyumjev U-100 (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 be given by continuous infusion under the skin (subcutaneously) through an insulin pump into an area of your body recommended in the instructions that come with your insulin pump. Lyumjev U-200 cannot be given through an insulin pump.

Lyumjev U-100 can also be given in your vein (intravenously) by your healthcare provider. Lyumjev U-200 cannot be given in your vein.

The Lyumjev Tempo Pen contains a component that allows for data connectivity when used with a compatible transmitter. A healthcare provider will teach you how to properly use Lyumjev by yourself.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors or has particles in it. Call your pharmacist for new medicine.

Your healthcare provider will show you where on your body to inject Lyumjev. Use a different place each time you give an injection. Do not inject into the same place two times in a row. Do not inject into skin that is damaged, tender, bruised, pitted, thickened, scaly, or has a scar or hard lump.

Do not transfer Lyumjev U-200 from the KwikPen to a syringe as overdosage and severe hypoglycemia can result.

Never share a Lyumjev injection pen, cartridge, or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

Keep Lyumjev in its original container protected from heat and light. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) Lyumjev:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 28 days.

Storing opened (in use) Lyumjev:

• Store the vial in a refrigerator or at room temperature and use within 28 days.

• Store the cartridge or injection pen (without a needle attached) at room temperature and use within 28 days.

Use a needle and syringe only once and place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

You should not use Lyumjev if you are allergic to insulin lispro, or if you are having an episode of hypoglycemia (low blood sugar).

To make sure Lyumjev is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• heart problems; or

• low levels of potassium in your blood (hypokalemia).

Tell your doctor if you also take medicine that contains pioglitazone or rosiglitazone. Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using Lyumjev if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Since Lyumjev is used with meals, you may not be on a timed dosing schedule. Whenever you use Lyumjev, follow the directions for your specific brand about whether to use the medicine before of after you eat. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how Lyumjev will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol.

Get emergency medical help if you have signs of an allergy to Lyumjev: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

• weight gain, swelling in your hands or feet, feeling short of breath;

• low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or

• low potassium - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common Lyumjev side effects may include:

• low blood sugar (hypoglycemia);

• allergic reactions;

• rash.

• weight gain;

• swelling in your hands or feet;

• itching (pruritus); or

• thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.