Insulin glulisine (Injection)

When This Medicine Should Not Be Used

Drugs and Foods to Avoid

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

• Make sure your doctor knows if you are using aspirin, clonidine (Catapres®), danazol (Danocrine®), disopyramide (Norpace®), epinephrine, fluoxetine (Prozac®), glucagon, guanethidine (Ismelin®), isoniazid (Nydrazid®), lithium (Eskalith®), niacin (vitamin B3), pentamidine (Nebupent®), pentoxifylline (Trental®), propoxyphene (Darvon®), reserpine (Harmonyl®), pramlintide (Symlin®), salbutamol (Ventolin®), somatropin (Nutropin®), terbutaline (Bricanyl®), thyroid replacement hormone, estrogen hormone, or birth control pills. Tell your doctor if you are also using a medicine for HIV or AIDS (such as amprenavir, indinavir, nelfinavir, ritonavir, saquinavir, Crixivan®, Fortovase®, Invirase®, Norvir®, or Viracept®), a sulfa drug (such as Bactrim® or Septra®), oral diabetes medicine (such as glyburide, Avandia®, Glucotrol®, or Glucophage®), a steroid (such as cortisone, prednisone, or methylprednisolone), a phenothiazine medicine (such as prochlorperazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, or Trilafon®), an MAO inhibitor (Eldepryl®, Marplan®, Nardil®, or Parnate®), blood pressure medicine (such as atenolol, enalapril, lisinopril, metoprolol, propranolol, timolol, Accupril®, Lotrel®, Zestril® Inderal®, or Toprol®), or medicine to lower cholesterol (such as gemfibrozil, fenofibrate, Lopid®, or Tricor®).
• Make sure your doctor knows if you are also using any medicines that can lower the potassium levels in your blood. One kind of medicine that can affect blood potassium is a diuretic or "water pill" (such as furosemide, hydrochlorothiazide, or Lasix®).
• Do not drink alcohol while you are using this medicine.

Introduction

Insulin Glulisine (IN-su-lin GLOO-lis-een)

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 is similar to regular insulin, but acts in the body more quickly.

Brand Name(s)

Apidra Solostar, Apidra

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 using a needle and syringe, or an insulin pump. It may also be given through a needle placed into a vein.
• Do not change the brand 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 it is the correct insulin.
• If you are using this insulin at meal times, give your injection within 15 minutes before a meal or within 20 minutes after starting a meal.
• A nurse or other trained health professional will give you 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 and give yourself the shots.
• 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 Apidra®, only use syringes that are made for giving insulin injections. Use a new syringe each time you give yourself an injection.
• The insulin should look clear and colorless. Do not use insulin glulisine if it is cloudy or thickened.
• As of July 1, 2010 the cartridges will no longer be available for the OptiClik® insulin delivery device system. Please contact your doctor or pharmacist if you have any questions about this.

If a dose is missed:

• Call your doctor or pharmacist for instructions.

How to Store and Dispose of This Medicine

• Store unused vials, SoloStar® prefilled pens, or cartridges in the refrigerator. Do not freeze.
• The vials that you are currently using may be kept in the refrigerator or at room temperature in a cool place, away from sunlight and heat, and must be used within 28 days.
• The cartridge or SoloStar® prefilled pen that you are currently using should not be refrigerated and must be stored at room temperature, away from direct heat and light. Throw away any opened cartridge or prefilled pen after 28 days. Do not store the OptiClik® insulin delivery device, with or without the cartridge system, in the refrigerator.
• As of July 1, 2010 the cartridges will no longer be available for the OptiClik® insulin delivery device system. Please contact your doctor or pharmacist if you have any questions about this.
• 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.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, hypokalemia (low potassium in the blood), or if you have any kind of infection or stress.
• Insulin glulisine 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.
• 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 (hypoglycemia) while you are using insulin. This is more likely if you miss a meal, exercise for a long time, or drink alcohol.
• 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 breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• Your doctor will need to check your progress 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
• Anxiety, irritability, confusion, or mood changes
• Blurred vision or slurred speech
• Dry mouth, increased thirst, muscle cramps, nausea, or vomiting
• Fast heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Rapid weight gain
• Seizures or shakiness
• Swelling in your hands, ankles, or feet

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

• Gaining weight around your neck, upper back, breast, face, or waist
• Headache
• Muscle or joint pain
• Redness, itching, swelling, or any changes in your skin where the shot or injection was 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