Insulin Glulisine (rDNA origin) Injection (patient information)

# Why this medication is prescribed
Insulin glulisine is used to treat type 1 diabetes (condition in which the body does not make insulin and therefore cannot control the amount of sugar in the blood). It is also used to treat people with type 2 diabetes (condition in which the blood sugar is too high because the body does not produce or use insulin normally) who need insulin to control their diabetes. Insulin glulisine is a man-made version of human insulin that begins working quickly and continues to work for a short time to control increases in blood sugar that may occur after meals. It is used together with a longer-acting insulin or an insulin pump (a device that delivers insulin to the body at all times through a small tube that is inserted under the skin) to control blood sugar. Insulin glulisine works by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

# How this medication should be used
Insulin glulisine comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually injected up to 15 minutes before a meal or within 20 minutes after starting a meal. Insulin glulisine can also be infused under the skin using an external insulin pump. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use insulin glulisine exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
Never use insulin glulisine when you have symptoms of hypoglycemia (low blood sugar) or if you have checked your blood sugar and found it to be low. Call your doctor in these cases.
Insulin glulisine controls diabetes but does not cure it. Continue to use insulin glulisine even if you feel well. Do not stop using insulin glulisine 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.
Insulin glulisine comes in vials and in cartridges.The cartridges are designed to be placed in dosing pens. Be sure you know what type of container your insulin glulisine comes in and what other supplies, such as needles, syringes, or pens, you will need to inject your medication.
If your insulin glulisine comes in vials, you will need to use syringes or an insulin pump to inject your dose. Always use a syringe marked for U-100 insulin to be sure that you get the right dose. Ask your doctor or pharmacist if you have questions about the type of syringe you should use. Carefully read the manufacturer's instructions to learn how to draw insulin glulisine into a syringe and inject your dose. Ask your doctor or pharmacist if you have questions about how to inject your dose.
If your insulin glulisine comes in cartridges, you will need to buy an insulin pen separately. Check the manufacturer's information to see what type of pen is right for insulin glulisine cartridges . Ask your doctor or pharmacist if you have any questions about the type of pen you should use. Carefully read the instructions that come with your pen, and ask your doctor or pharmacist to show you how to use it.
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. Throw away needles and syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture- resistant container.
Insulin glulisine may be mixed only with NPH insulin (Novolin N, Humulin N) to be injected using a syringe. Do not mix or dilute insulin glulisine with any other type of insulin. If you mix insulin glulisine with NPH insulin, draw insulin glulisine into the syringe first, then draw the NPH insulin into the syringe and inject the solution immediately after mixing.If you use insulin glulisine in an insulin pump, do not dilute insulin glulisine or mix it with any other insulin or solution.
Always look at your insulin glulisine before you inject it. It should be as clear, colorless, and fluid as water. Do not use your insulin glulisine if it is colored, cloudy, thickened, or contains solid particles, or if the expiration date on the bottle has passed.
If you use syringes or a pen, you may inject insulin glulisine into your upper arm; stomach area, except for a two inch circle around the navel (belly button); or upper leg. If you use an insulin pump, infuse insulin glulisine into your stomach area. Never inject insulin glulisine into muscles or veins,or in or near moles or scars. Use a different site for each injection, about 1 inch away from the previous injection site but in the same general area (for example, the thigh). Use all available sites in the same general area before switching to a different area (for example, the upper arm).
If you use insulin glulisine in an insulin pump, change the tubing and needle and throw away any solution left in the reservoir at least every 48 hours. You should also change the infusion site (spot where the pump is attached to the body) at least every 48 hours.You may need to change the needles, tubing, infusion site, and medication more often if the medication has been exposed to high temperatures or direct sunlight, if your blood sugar increases unexpectedly, if the skin around the infusion site becomes irritated, or if there are problems with your pump. Be sure that you know what to do if you have any problems with your pump. Your blood sugar may increase very quickly if your pump stops working, and you may need to inject insulin with a syringe. Read the manufacturer's information carefully and ask your doctor or pharmacist for more information.

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

# Special precautions
Before using insulin glulisine:
- tell your doctor and pharmacist if you are allergic to insulin (Humulin, Novolin, others) or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); albuterol (Proventil, Ventolin, Vospire ER); antihistamines; beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal); clonidine (Catapres, Catapres-TTS, ); danazol; diazoxide (Proglycem); disopyramide (Norpace);; diuretics ('water pills'); epinephrine (Bronitin Mist, EpiPen, Primatene Mist); fenofibrate (Antara, Lipofen, Tricor); fluoxetine (Prozac, Sarafem); gemfibrozil (Lopid); glucagon (Glucagen); guanethidine (Ismelin); hormone replacement therapy; isoniazid (INH, Laniazid); lithium (Eskalith, Lithobid); medications for asthma, colds, irregular menstrual bleeding, and nausea; certain medications for human immunodeficiency virus (HIV) including amprenavir (Agenerase), atazanavir (Reyataz), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (in Kaletra, Norvir), saquinavir (Invirase), and tipranavir (Aptivus); certain antipsychotics (medications for mental illness) including clozapine (Clozaril, Fazaclo) and olanzapine (Zyprexa, in Symbyax); monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); hormonal contraceptives (birth control pills, patches, rings, injections, or implants); oral medications for diabetes; oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone); pentoxifylline (Pentoxil, Trental); propoxyphene (Darvon, in Darvocet, in Wygesic); reserpine (Serpalan); salicylate pain relievers such as aspirin; somatropin (Humatrope, Norditropin, Nutropin); sulfa antibiotics; terbutaline (Brethine); 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 or kidney or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using insulin glulisine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin glulisine.
- ask your doctor what to do if you get sick, experience unusual stress, plan to travel across time zones, or change your exercise and activity level. These changes can affect your blood sugar and the amount of insulin you may need.

# Special dietary instructions
Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy 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.
Alcohol may cause a decrease in blood sugar. Ask your doctor about the safe use of alcoholic beverages while you are using insulin glulisine.

# What to do if you forget a dose
Insulin glulisine must be injected up to 15 minutes before or within 20 minutes after starting a meal. If some time has passed since your meal, check your blood sugar and 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.

# Side effects

## Minor side effects
Insulin glulisine 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.
You may experience hypoglycemia (low blood sugar) while you are taking this medication. Your doctor will tell you what you should do if you develop hypoglycemia. He or she may tell you to check your blood sugar, eat or drink a food or beverage that contains sugar, such as hard candy or fruit juice, or get medical care. Follow these directions carefully if you have any of the following symptoms of hypoglycemia:
- shakiness
- dizziness or lightheadedness
- sweating
- nervousness or irritability
- sudden changes in behavior or mood
- headache
- numbness or tingling around the mouth, hands, or feet
- weakness
- pale skin
- hunger
- clumsy or jerky movements
- nightmares
- difficulty falling asleep or staying asleep
- blurred vision
- slurred speech
- fast heartbeat
If hypoglycemia is not treated, severe symptoms may develop. Be sure that your family, friends, and other people who spend time with you know that if you have any of the following symptoms, they should get medical treatment for you immediately.
- confusion
- seizures
- loss of consciousness
Call your doctor immediately if you have any of the following symptoms of hyperglycemia (high blood sugar):
- extreme thirst
- frequent urination
- extreme hunger
- weakness
- blurred vision
If high blood sugar is not treated, a serious, life-threatening condition called diabetic ketoacidosis could develop. Get medical care immediately if you have any of these symptoms:
- dry mouth
- nausea and vomiting
- stomach pain
- shortness of breath
- breath that smells fruity
- decreased consciousness
Insulin glulisine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- redness, swelling, or itching at the site of the injection
- changes in the feel of your skin, skin thickening (fat build-up), or a little indentation in *the skin (fat breakdown)
- muscle pain

## Severe side effects
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
- rash and/or itching over the whole body
- shortness of breath
- wheezing
- dizziness
- blurred vision
- fast heartbeat
- sweating
- difficulty breathing or swallowing
Insulin glulisine may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

# Storage conditions are needed for this medication
Store unopened insulin glulisine vials and cartridges in the refrigerator away from light. Do not freeze. Opened insulin glulisine vials may be refrigerated or may be stored at room temperature, away from direct sunlight and heat, for up to 28 days. Opened insulin glulisine cartridges that have not been inserted into a pen may be refrigerated or may be stored at room temperature, away from direct heat and sunlight, for up to 28 days. Opened insulin glulisine cartridges that have been inserted into a pen should not be refrigerated; they should be stored inside the pen at room temperature for up to 28 days after the first use. Throw away opened insulin glulisine cartridges and vials after 28 days. Throw away unopened, refrigerated insulin glulisine after the expiration date printed on the label has passed.Throw away any insulin glulisine that has been frozen or exposed to extreme heat.
Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

# In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- loss of consciousness
- seizures
- confusion

# Other information
Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to insulin glulisine. Your doctor will also tell you how to check your response to insulin by measuring your blood or urine 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.

# Brand names
- Apidra