Insulin Lispro Injection

IMPORTANT NOTICE:

Insulin lispro and insulin lispro-aabc are biologic medications (medications made from living organisms). Biosimilar insulin lispro-aabc injection is highly similar to insulin lispro and works the same way as insulin lispro in the body. Therefore, the term insulin lispro products will be used to represent these medications in this discussion.

WHY is this medicine prescribed?

Insulin lispro injection products are used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood). Insulin lispro injection products are also used to treat people with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) who need insulin to control their diabetes. In patients with type 1 diabetes, insulin lispro injection products are always used with another type of insulin, unless it is used in an external insulin pump. In patients with type 2 diabetes, insulin lispro injection products may be used with another type of insulin or with oral medication(s) for diabetes. Insulin lispro injection products are a short-acting, manmade version of human insulin. Insulin lispro injection products work by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. They also stops the liver from producing more sugar.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease.Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

HOW should this medicine be used?

Insulin lispro injection products come as a solution (liquid) and a suspension (liquid with particles that will settle on standing) to inject subcutaneously (under the skin). Insulin lispro solution (Admelog, Humalog) is usually injected within 15 minutes before a meal or immediately after a meal. Insulin lispro suspension (Humalog Mix 75/25 or Humalog Mix 50/50) should be injected 15 minutes before a meal. Insulin lispro-aabc solution (Lyumjev) should be injected at the beginning of a meal or within 20 minutes after you start eating a meal.Your doctor will tell you how many times you should inject insulin lispro products each day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use insulin lispro injection products exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Insulin lispro injection products may also be injected intravenously (into a vein) by a doctor or nurse in a healthcare setting. A doctor or nurse will carefully monitor you for side effects.

Never use insulin lispro injection products when you have symptoms of hypoglycemia (low blood sugar) or if you have checked your blood sugar and found it to be low.

Insulin lispro injection products control diabetes but do not cure it. Continue to use insulin lispro products even if you feel well. Do not stop using insulin lispro injection products without talking to your doctor. Do not switch to another brand or type of insulin or change the dose of any type of insulin you are using without talking to your doctor. Always check the insulin label to make sure you received the right type of insulin from the pharmacy.

Insulin lispro injection products come in vials, cartridges that contain medication and are to be placed in dosing pens, and dosing pens that contain cartridges of medication. Be sure you know what type of container your insulin lispro comes in and what other supplies, such as needles, syringes, or pens you will need to inject your medication.

If your insulin lispro injection product comes in vials, you will need to use syringes to inject your dose. Ask your doctor or pharmacist to show you how to inject an insulin lispro injection product using a syringe. Ask your doctor or pharmacist if you have questions about the type of syringe you should use.

If your insulin lispro injection product comes in cartridges, you will need to purchase an insulin pen separately. Check the manufacturer's information for the patient to see what type of pen is right for the cartridge size you are using. Carefully read the instructions that come with your pen, and ask your doctor or pharmacist to show you how to use it. Ask your doctor or pharmacist if you have questions about the type of pen you should use.

If your insulin lispro injection product comes in pens, be sure to read and understand the manufacturer's instructions. Ask your doctor or pharmacist to show you how to use the pen. Follow the directions carefully, and always prime the pen before use.

Never reuse needles or syringes and never share needles, syringes, cartridges, or pens. If you are using an insulin pen, always remove the needle right after you inject your dose. Dispose of needles and syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

Your doctor may tell you to mix your insulin lispro solution with another type of insulin (NPH insulin) in the same syringe. Your doctor will tell you exactly how to do this. Always draw insulin lispro into the syringe first, always use the same brand of syringe, and always inject the insulin immediately after mixing. Insulin lispro injection products should not be mixed with insulin preparations other than NPH insulin. Insulin lispro suspension should not be mixed with any other insulin preparations.

Your doctor may tell you to dilute insulin lispro injection products before injection to allow easier measurement of your dose. Your doctor will tell you exactly how to do this.

You can inject your insulin lispro injection product in your thighs, stomach, upper arms, or buttocks. Change (rotate) the injection site within the chosen area with each dose. Do not inject where the skin is thick, lumpy, tender, bruised, scaly, hard, or into areas of skin where there are scars or skin is damaged.

Always look at your insulin lispro product before you inject it. If you are using insulin lispro solution, the insulin should be clear and colorless. Do not use this type of insulin lispro product if it is colored, cloudy, or contains solid particles. If you are using insulin lispro suspension, the insulin should appear cloudy or milky after you mix it. Do not use this type of insulin product if there are clumps in the liquid or if there are solid white particles sticking to the bottom or walls of the bottle. Do not use any type of insulin after the expiration date printed on the bottle has passed.

Insulin lispro suspension must be gently shaken or rolled between your hands to mix before use. Ask your doctor or pharmacist if the type of insulin you are using should be mixed and how you should mix it if necessary.

Insulin lispro solution (Admelog, Humalog U-100, Lyumjev U-100) also can be used with an external insulin pump. Before using insulin lispro products in a pump system, read the pump label to make sure the pump can be used for continuous delivery of fast-acting insulin. Read the pump manual for recommended reservoir and tubing sets, and ask your doctor or pharmacist to show you how to use the insulin pump. Do not dilute insulin lispro or mix it with any other type of insulin when using it with an external insulin pump. When using insulin lispro products with an external insulin pump, replace the insulin in the reservoir at least every 7 days (Admelog, Humalog U-100,) or at least every 9 days (Lyumjev U-100), and change the infusion set and infusion set insertion site at least every 3 days. If the infusion site is red, itchy, lumpy, or thickened, tell your doctor and use a different infusion site.

When using insulin lispro solution in an external insulin pump, high blood sugar may occur quickly if the pump stops working properly or if the insulin in the pump reservoir is exposed to direct sunlight or temperatures greater than 98.6°F (37°C). High blood sugar may also occur if the tubing leaks or becomes blocked, disconnected, or kinks. If the problem cannot be found quickly and corrected, call your doctor right away. You may need to temporarily use insulin by subcutaneous injection (using syringes or an insulin pen). Make sure you have back-up insulin and any necessary supplies on hand, and ask your doctor or pharmacist to show you how to use them.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using an insulin lispro injection product,

• tell your doctor and pharmacist if you are allergic to insulin (Humulin, Novolin, others), insulin lispro, insulin lispro-aabc, any of the ingredients of insulin lispro injection products, or any other medications. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, Qbrelis, Zestril, in Zestoretic), moexipril, perindopril, (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (in Tarka); angiotensin receptor blockers such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (Diovan, in Diovan HCT, in Entresto, in Exforge); beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); certain cholesterol-lowering medications such as fenofibrate (Antara, Lipofen, TriCor, Triglide, others), gemfibrozil (Lopid), and niacin (Niacor, Niaspan, in Advicor); certain medications for human immunodeficiency virus (HIV) including atazanavir (Reyataz, in Evotaz), darunavir (Prezista, in Prezcobix, in Symtuza), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus); clonidine (Catapres); clozapine (Clozaril, Versacloz); danazol; disopyramide (Norpace); diuretics ('water pills'); fluoxetine (Prozac, in Symbyax); hormone replacement therapy; isoniazid (in rifater, rifamate); lithium (Lithobid); medications for asthma and colds; medications for mental illness and nausea; monoamine oxidase inhibitors including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam, Zelapar) and tranylcypromine (Parnate); octreotide (Mycapssa, Sandostatin); olanzapine (Zyprexa, in Symbyax); oral contraceptives (birth control pills); oral medications for diabetes such as pioglitazone (Actos, in Actoplus Met and others) and rosiglitazone (Avandia); oral steroids such as dexamethasone (Hemady), methylprednisolone (Medrol), and prednisone (Rayos); patiromer (Veltassa); pentamidine (NebuPent, Pentam); pentoxifylline; pramlintide (Symlin); reserpine; salicylate pain relievers such as aspirin, choline magnesium trisalicylate (Trisalate), choline salicylate (Arthropan), diflunisal, magnesium salicylate (Doan's, others), and salsalate (Argesic, Disalcid, Salgesic); sodium polystyrene sulfonate (Kalexate, Kionex, SPS); somatropin (Nutropin, Serostim, others); sulfa antibiotics; and thyroid medications. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had nerve damage caused by your diabetes; heart failure; low blood levels of potassium; or if you have any other medical conditions, including heart, liver, or kidney disease. Also tell your doctor if you frequently have episodes of hypoglycemia.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using insulin lispro injection products, call your doctor.

• Alcohol may cause a change in blood sugar. Ask your doctor about the safe use of alcoholic beverages and prescription or over the counter medications that contain alcohol while you are using an insulin lispro injection product.

• ask your doctor what to do if you get sick, experience unusual stress, or change your diet, exercise, or activity schedule. These changes can affect your dosing schedule and the amount of insulin you will need.

• you should know when you first start using insulin lispro injection products or have a large dose increase you may experience blurry vision or other vision problems, or a painful, burning, weak or numb sensation in your hands, arms, feet, or legs. These side effects should go away, but tell your doctor if these effects continue.

• ask your doctor how often you should check your blood sugar. Be aware that hypoglycemia may affect your ability to perform tasks such as driving and ask your doctor if you need to check your blood sugar before driving or operating machinery.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet, and to eat about the same amounts of the same kinds of food at about the same times each day. Skipping or delaying meals or changing the amount or kind of food you eat can cause problems with your blood sugar control.

What should I do IF I FORGET to take a dose?

Insulin lispro injection products must be injected shortly before or after a meal. If you remember your dose before or shortly after your meal, inject the missed dose right away. If some time has passed since your meal, follow the instructions provided by your doctor or call your doctor to find out whether you should inject the missed dose. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Insulin lispro injection products may cause side effects. Tell your doctor if the following symptoms are severe or do not go away:

• redness, swelling, or itching in the place where you injected insulin lispro
• changes in the feel of your skin such as skin thickening or a little indentation or lumps in the skin
• weight gain
• constipation

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

• rash and itching, difficulty breathing, hives, wheezing, fast heartbeat, sweating, and feeling drowsy, dizzy or confused
• swelling of the face, tongue, or throat
• weakness, muscle cramps, abnormal heartbeat
• shortness of breath
• large weight gain in a short period of time
• swelling of the arms, hands, feet, ankles, or lower legs

Insulin lispro may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in and out of reach of children. Store unopened insulin lispro vials, cartridges, and pens in the refrigerator, but do not freeze them. Unopened refrigerated insulin lispro products can be stored until the date shown on the company's label. If a refrigerator is unavailable (for example, when on vacation), store the unopened vials, cartridges, or pens of insulin lispro solution (Admelog, Humalog, Lyumjev) at room temperature and away from direct sunlight and extreme heat. Unrefrigerated unopened vials, cartridges, and pens of insulin lispro solution (Admelog, Humalog, Lyumjev) can be used within 28 days, but after that time they must be discarded. Unrefrigerated unopened vials of insulin lispro suspension (Humalog 50/50, Humalog 70/25) can be used within 28 days and unrefrigerated, unopened pens can be used within 10 days; after that time they must be discarded.

Opened vials of insulin lispro solution (Admelog, Humalog) can be stored for 28 days at room temperature or in the refrigerator. If your doctor tells you to dilute your insulin lispro injection product solution, a vial of diluted Humalog can be stored for 28 days in the refrigerator or 14 days at room temperature, a vial of diluted Admelog can be stored for 1 day (24 hours) in the refrigerator or 4 hours at room temperature, and a vial of diluted Lyumjev can be stored for 4 days in the refrigerator or 12 hours hours at room temperature. Opened insulin lispro solution (Admelog, Humalog) cartridges and pens may be stored at room temperature for up to 28 days; do not refrigerate them. Opened pens containing Humalog 50/50 or Humalog 75/25 may be stored at room temperature for up to 10 days; do not refrigerate them. Opened insulin lispro solution (Lyumjev) pens can be stored at room temperature for up to 28 days. Discard any insulin lispro product that has been exposed to extreme heat or cold.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Insulin lispro overdose can occur if you use too much insulin lispro injection products or if you use the right amount of insulin lispro injection product but eat less than usual or exercise more than usual. Insulin lispro overdose can cause hypoglycemia. If you have any symptoms of hypoglycemia, follow your doctor's instructions for what you should do if you develop hypoglycemia. Other symptoms of overdose:

• coma
• seizures

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to insulin lispro injection products. Your doctor will also tell you how to check your response to insulin lispro injection products by measuring your blood sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.