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

Treats diabetes mellitus. Insulin is a hormone that helps get sugar from the blood to the muscles, where it is used for energy. This type of insulin starts working faster than regular insulin.

Brand Name(s):

Humalog, Humalog Pen, Insulin-Humalog, Lispro-PFC

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
• Insulin pump: Keep the pump and pump equipment away from heat and direct light. Heat may increase the temperature of the insulin, and prevent it from working as it should.
• IV: A nurse or other trained health professional may give you this medicine into a vein if you are in the hospital.
• Do not change the brand, type, or dose of your insulin unless your doctor tells you to. When you receive a new supply of insulin, check the label to be sure if it is the correct type of insulin.
• Use this medicine 15 minutes before a meal or right after you eat.
• Test your blood sugar regularly while you are using this medicine.
• A doctor, nurse, or pharmacist should teach you how to give your insulin shots. Make sure you understand how to use the medicine, give yourself the shots, or use the insulin pump.
• Follow the special diet and use the correct dose of insulin that your doctor orders. Diet, exercise, medicine, and checking your blood sugar are important to control your diabetes.
• 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.
• Vial: Only use syringes that are made for insulin injections. Use a new syringe each time you give yourself an injection. Never share insulin pens with others.
• Cartridge or pen: Use a new needle each time with this pen. Never share your cartridges with others.
• Insulin pump: Use insulin lispro by itself. Do not mix it with other insulins. Change the insulin solution in the reservoir of the insulin pump at least every 7 days, and change the infusion set and infusion site at least every 3 days. Make sure your pump is meant for fast-acting insulin. Tell your doctor right away if your insulin pump breaks or leaks. Your blood sugar levels may change rapidly. You may need to give yourself injections until your pump is fixed.
• Do not mix different types of insulin, unless your doctor tells you to. Draw up insulin lispro into the syringe first, if you are told to mix it with a longer-acting insulin. Then draw up the longer-acting insulin and inject it right away.
• The insulin solution should look clear and colorless. Do not use insulin lispro if it is cloudy or clumpy.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine:

• Keep all medicine away from heat and direct light.
• New, unused medicine: Store unused vials, pens, or cartridges in the refrigerator. Do not freeze. This medicine may be refrigerated for only 28 days. Throw the medicine away after the expiration date has passed.
• Medicine that is currently being used:
  • Vials: Vials of medicine that you are currently using may be kept in the refrigerator or at room temperature for up to 28 days.
  • Cartridge or pen: Do not refrigerate your cartridge or pen that you are currently using. Store the cartridge or pen at room temperature in a cool place, away from heat and direct light, up to 28 days.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Keep all medicine away from children and never share your medicine with anyone.

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 you are using.
• Do not drink excess alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. Tell your doctor if you have kidney or liver disease.
• Insulin lispro starts to work faster than some other types of insulin, and its effects do not last as long. It should act more like the insulin your body would normally produce. Because the effects of insulin lispro are short-acting, your doctor may also prescribe a longer-acting insulin for you to use.
• You might sometimes have low blood sugar while you are using insulin. This is more likely if you miss a meal, exercise for a long time, or drink alcohol.
• You might sometimes have high blood sugar if you miss a dose, you do not take enough insulin, you overeat or do not follow your meal plan, or you do not exercise as much as usual.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

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
• Hunger, confusion
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting
• Fast, pounding, or uneven heartbeat
• Lightheadedness, fainting
• Shaking, trembling, sweating
• Trouble breathing

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

• Redness, itching, swelling, or any changes in your skin where the shot is given

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