Insulin Lispro-aabc, Recombinant (IN-su-lin LIS-pro - aabc, ree-KOM-bi-nant)

Treats diabetes.

Brand Name(s):

Lyumjev KwikPen U-100, Lyumjev Kwikpen U-200, Lyumjev Tempo Pen, Lyumjev U-100

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin (eg, stomach, thigh, buttocks, or upper arm) or into a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.
• When used as a mealtime insulin, it should be taken at the start of a meal or within 20 minutes after you start a meal.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not use the exact same spot for each injection.
• Do not inject into skin areas that are tender, bruised, scaly, hard, damaged, thick, or has pits, lumps, or scars.
• This medicine should be clear and colorless before you use it. Do not use it if it looks cloudy or has particles in it.
• Use a new needle and syringe each time you inject your medicine. If you use a syringe, use only the kind that is made for insulin injections. Some insulins must be given with a specific type of syringe or needle. Ask your pharmacist if you are not sure which one to use.
• KwikPen®, Tempo Pen™, or Junior KwikPen®:
  • Wash your hands with soap and water.
  • Prime the pen by removing the air from the needle and cartridge. Select 2 units when turning the dose knob.
  • Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
  • Push the dose knob until it stops. You should see a "0" in the dose window. Hold the dose knob in and slowly count to 5.
  • You should see insulin at the needle tip. If you do not see insulin, repeat the priming steps but not more than 4 times. If there is still no insulin, change the needle then repeat the priming steps.
  • If your dose is more than 60 units (30 units for Junior KwikPen®), you will need to give more than 1 injection. Use a new needle for each injection and repeat the priming steps.
  • When taking your dose, turn the dose knob to select the number of units you need to inject. The pen dials 1 unit (0.5 unit for Junior KwikPen®) at a time and the dose knob clicks as you turn it. Do not dial your dose by counting the clicks as this can lead to you getting too much or too little insulin.
  • Insert the needle into your skin and push the knob all the way in. Continue to hold it, then slowly count to 5 before removing it.
  • If you see "0" in the dose window, you have received the full dose. Do not redial if you do not see a "0". Reinsert the needle into your skin and finish the injection.
  • If you need 2 injections for a full dose, be sure to take the second injection.
  • Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Store the pen without a needle attached. Do not use the pen if it is broken or damaged.
• Vial:
  • Wash your hands with soap and water.
  • Use only syringes that are made for insulin injections. Use a new syringe and needle each time you give yourself an injection.
  • Do not mix this medicine with any other insulin.
  • When used in an insulin pump: Carefully read and follow the external insulin pump instructions. This insulin should not be mixed with any other insulin or diluted when used in an insulin pump. The insulin lispro-aabc in the pump should be changed at least every 9 days or any time that the insulin is over 98.6°F (37°C). If you do not understand how you are to use the insulin pump, contact your doctor or pharmacist.
• Do not transfer Lyumjev™ U-200 from the prefilled pen to a syringe for use.
• Always check the label before use to make sure you have the correct type of insulin. Do not change the brand, type, or concentration unless your doctor tells you to. If you use an infusion pump or other device, make sure the insulin is made for that device.
• Missed dose: Call your doctor or pharmacist for instructions.
• Unopened medicine: Store the vials, pens, and cartridges in the refrigerator. You may store the medicine at room temperature for 28 days. Protect from light. Do not freeze. Do not use the insulin if it has been frozen. Throw away any unused medicine after 28 days.
• Opened medicine:
  • Prefilled pens and cartridges:Store at room temperature, away from direct heat and light. Do not refrigerate. Throw away any opened pen or cartridge after 28 days.
  • Vials: Store in the refrigerator or at room temperature in a cool place, away from sunlight and heat. Use within 28 days.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can change the amount of insulin you need to use and make it harder for you to control your diabetes. Make sure your doctor knows about all other medicines that you are using.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, or heart failure.
• This medicine may cause the following problems:
  • Low blood sugar
  • Fluid retention or heart failure (when used together with a thiazolidinedione [TZD] medicine)
  • Ketoacidosis (high ketones and acid in the blood)
• This medicine may make you dizzy, drowsy, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Never share insulin pens, cartridges, or needles with anyone. Sharing these can pass hepatitis viruses, HIV, and other illnesses from one person to another.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, change in how much or how often you urinate, fruit-like breath odor, stomach pain, weakness
• Dry mouth, increased thirst, muscle cramps, nausea or vomiting, uneven heartbeat
• Fever, stuffy or runny nose, muscle aches, sore throat, headache
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Redness, itching, swelling, or any skin changes where the shot is given
• Skin rash or itching

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088