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

• 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.
• 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.
• If you are using this insulin at meal times, give your injection 15 minutes before a meal or right after you eat.
• A doctor, nurse, or pharmacist should teach you how to give your insulin shots. Make sure you understand how to use the medicine and give yourself the shots.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask 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.
• If you are using a vial (bottle) of HumaLog®, only use syringes that are made for giving insulin injections. Use a new syringe each time you give yourself an injection. If you are using a HumaLog® cartridge or pen, use a new needle each time.
• If you are using an insulin pump, you should use insulin lispro by itself. Do not dilute it or combine 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.
• Do not mix one kind of insulin with another, unless your doctor has told you to. If you are mixing insulin lispro and a longer-acting insulin in the same syringe, always draw up insulin lispro into the syringe first. Then draw up the longer-acting insulin and give the injection right away.
• The insulin solution should look clear and colorless. Do not use insulin lispro if it is cloudy or thickened.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine:

• Store unused vials, pens, or cartridges in the refrigerator. Do not freeze. The expiration date on the insulin package tells you how long you can keep the medicine in the refrigerator. Throw the medicine away after the expiration date has passed.
• The vial that you are currently using may be kept in the refrigerator or at room temperature in a cool place, away from direct heat and light, for only 28 days.
• The cartridge or pen that you are currently using should not be refrigerated. You should store the cartridge or pen at room temperature in a cool place, away from direct heat and light, for only 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 affect 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 alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant, planning to become pregnant, or breastfeeding. Tell your doctor if you have kidney disease 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.
• Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other blood-borne illnesses.
• 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 may 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.
• If your blood sugar gets too low, you may feel weak, drowsy, confused, anxious, or very hungry. You may also sweat, shake, or have blurred vision, a fast heartbeat, or a headache that will not go away. If you have symptoms of low blood sugar (hypoglycemia), check your blood sugar. If your blood sugar is 70 mg/dL (milligrams per deciliter) or below, do one of the following: Drink 4 ounces (one-half cup) of fruit juice, or eat 5 to 6 pieces of hard candy, or take 2 to 3 glucose tablets. Recheck your blood sugar 15 minutes later. If your blood sugar goes above 70 mg/dL, eat a snack or a meal. If your blood sugar is still below 70 mg/dL, drink one-half cup juice, or eat 5 to 6 pieces of candy, or take 2 to 3 glucose tablets. Carry candy or some type of sugar with you at all times, especially if you are away from home. You can take this if you feel that your blood sugar is too low, even if you do not have a blood glucose meter. Always carefully follow your doctor's instructions about how to treat your low blood sugar. Learn what to do if your blood sugar gets too low. Teach friends, coworkers, and family members what they can do to help if you have low blood sugar.
• Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine or insulin, you overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.
• Symptoms of high blood sugar include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in the urine; loss of appetite; stomachache; nausea or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; and unusual thirst.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• This medicine may not work as well if you have surgery, get hurt, or get sick. If you have severe vomiting, diarrhea, or fever, call your doctor for instructions.
• You may have some skin redness, rash, itching, or swelling at the injection site. If this irritation is severe or does not go away, call your doctor. Do not inject insulin lispro into a skin area that is red, swollen, or itchy.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests may be needed to check for unwanted effects.

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
• Anxiety, confusion, irritability, restlessness, or mood changes.
• Blurred vision or slurred speech.
• Dry mouth, muscle cramps, nausea, or vomiting.
• Fast, pounding, and uneven heartbeat.
• Fever, chills, cough, sore throat, and body aches.
• Headache, drowsiness, or sweating.
• Increased thirst, shakiness, or hunger.
• Lightheadedness, dizziness, or fainting.
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet.
• Rapid weight gain.
• Seizures or tremors.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Unusual tiredness or weakness.

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

• Colds or runny nose.
• Itching skin or rash.
• 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