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insulin glulisine

Generic Name: insulin glulisine (IN su lin GLOO lis een)
Brand Name: Apidra, Apidra SoloStar Pen, Apidra OptiClik Cartridge

What is insulin glulisine?

Insulin is a hormone that works by lowering levels of glucose (sugar) in the blood. Insulin glulisine is a fast-acting insulin that starts to work about 15 minutes after injection, peaks in about 1 hour, and keeps working for 2 to 4 hours.

Insulin glulisine is used to improve blood sugar control in adults and children with diabetes mellitus.

Insulin glulisine is used to treat type 2 diabetes in adults. Insulin glulisine is also used to treat type 1 diabetes in adults and children who are at least 4 years old.

Insulin glulisine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about insulin glulisine?

Never share an injection pen or syringe with another person, even if the needle has been changed.

What should I discuss with my healthcare provider before using insulin glulisine?

You should not use insulin glulisine if you are allergic to it, or if you are having an episode of hypoglycemia (low blood sugar).

Insulin glulisine should not be given to a child younger than 4 years old. Insulin glulisine should not be used to treat type 2 diabetes in a child of any age.

To make sure insulin glulisine is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • low levels of potassium in your blood (hypokalemia); or

  • diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you also take pioglitazone or rosiglitazone (sometimes contained in combinations with glimepiride or metformin). Taking certain oral diabetes medicines while you are using insulin may increase your risk of serious heart problems.

Follow your doctor's instructions about using insulin if you are pregnant or breast-feeding a baby. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy. Your dose needs may also be different while you are breast-feeding.

How should I use insulin glulisine?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Insulin glulisine is injected under the skin, or into a vein through an IV. You will be shown how to use injections at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

Your care provider will show you the best places on your body to inject insulin glulisine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

After using insulin glulisine, eat a meal within 15 minutes. If you did not use an injection before the meal, use the medicine within 20 minutes after you start eating.

If you use this medicine with an IV or insulin pump, do not mix or dilute insulin glulisine with any other insulin. Infusion pump tubing, catheters, and the needle location on your skin should be changed every 2 days. Change the medicine in the reservoir every 2 days.

If you use an injection pen, use only the injection pen that comes with insulin glulisine. Attach a new needle before each use. Do not transfer the insulin from the pen into a syringe or infusion pump.

Never share an injection pen or syringe with another person, even if the needle has been changed. Sharing these devices can allow infections or disease to pass from one person to another.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination, blurred vision, headache, and tiredness.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your insulin dose or schedule.

Insulin glulisine is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Keep this medicine in its original container protected from heat and light. Do not draw insulin from a vial into a syringe until you are ready to give an injection. Do not freeze insulin or store it near the cooling element in a refrigerator. Throw away any insulin that has been frozen.

Storing unopened (not in use) insulin glulisine:

  • Refrigerate and use until expiration date; or

  • Store at cool room temperature (below 77 degrees F) and use within 28 days.

Storing opened (in use) insulin glulisine:

  • Store the vial in a refrigerator or at cool room temperature and use within 28 days.

  • Store the injection pen at cool room temperature (do not refrigerate) and use within 28 days. Do not store the injection pen with a needle attached.

  • Store a prepared infusion bag at cool room temperature and use within 48 hours.

Do not use the medicine if it looks cloudy, has changed colors, or has any particles in it. Call your pharmacist for new medicine.

Wear a diabetes medical alert tag in case of emergency. Any medical care provider who treats you should know that you have diabetes.

What happens if I miss a dose?

Since insulin glulisine is used before meals, you may not be on a timed dosing schedule. Whenever you use insulin glulisine, be sure to eat a meal within 15 minutes. Do not use extra insulin glulisine to make up a missed dose.

Keep insulin on hand at all times. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Insulin overdose can cause life-threatening hypoglycemia. Symptoms include drowsiness, confusion, blurred vision, numbness or tingling in your mouth, trouble speaking, muscle weakness, clumsy or jerky movements, seizure (convulsions), or loss of consciousness.

What should I avoid while using insulin glulisine?

Insulin can cause low blood sugar. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid medication errors by always checking the medicine label before injecting your insulin.

Avoid drinking alcohol. It can cause low blood sugar and may interfere with your diabetes treatment.

Insulin glulisine side effects

Get emergency medical help if you have signs of insulin allergy: redness or swelling where an injection was given, itchy skin rash over the entire body, trouble breathing, fast heartbeats, feeling like you might pass out, or swelling in your tongue or throat.

Call your doctor at once if you have:

  • fluid retention--weight gain, swelling in your hands or feet, feeling short of breath; or

  • low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • low blood sugar;

  • itching, mild skin rash; or

  • thickening or hollowing of the skin where you injected the medicine.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Insulin glulisine dosing information

Usual Adult Dose for Diabetes Type 1:

Individualize dose based on metabolic needs and frequent monitoring of blood glucose
-Total daily insulin requirements (prandial plus basal) are generally between 0.5 to 1 unit/kg/day
-Use HbA1c values to guide therapy; consult current guidelines for optimal target ranges

Multiple-daily injection (MDI):
-Administer subcutaneously within 15 minutes before a meal or within 20 minutes after starting a meal
-Match prandial insulin dose to carbohydrate intake, pre-meal blood glucose, and anticipated activity
-Use in combination with an intermediate-acting or long-acting basal insulin

Continuous Subcutaneous Infusion (Insulin Pump)
-Initial programming should be based on the total daily insulin dose of previous MDI regimen; check with pump labeling to ensure the pump has been evaluated with this insulin

Intravenous Administration
-Dilute to a concentration of 0.05 to 1 unit/mL in normal saline in an infusion system using polyvinyl chloride (PVC) bags; closely monitor blood glucose and serum potassium during administration

Use: To improve glycemic control in adult patients with diabetes mellitus.

Usual Adult Dose for Diabetes Type 2:

Individualize dose based on metabolic needs and frequent monitoring of blood glucose
-Use HbA1c values to guide therapy; consult current guidelines for optimal target ranges.

Prandial Insulin:
-Administer subcutaneously within 15 minutes before a meal or within 20 minutes after starting a meal
-Use in combination with an intermediate-acting or long-acting basal insulin and/or with other anti-diabetic agents

Continuous Subcutaneous Infusion (Insulin Pump)
-Initial programming should be based on the total daily insulin dose of previous MDI regimen; check with pump labeling to ensure the pump has been evaluated with this insulin

Intravenous Administration
-Dilute to a concentration of 0.05 to 1 unit/mL in normal saline in an infusion system using polyvinyl chloride (PVC) bags; closely monitor blood glucose and serum potassium during administration

Use: To improve glycemic control in patients with diabetes mellitus.

Usual Adult Dose for Diabetic Ketoacidosis:

Successful treatment of hyperglycemic emergencies such as diabetic ketoacidosis (DKA) and hyperosmolar state (HHS) requires frequent monitoring of clinical and laboratory parameters while carefully correcting volume deficits, managing electrolytes, and normalizing blood glucose. Insulin therapy is used to slowly correct high glucose levels; consult current treatment protocols for specific guidance on fluid and electrolyte management.

Intravenous:
-IV insulin infusion is generally started 1 to 2 hours after initiating fluid replacement therapy
-Dose: 0.14 unit/kg/hour IV; alternatively, a bolus of 0.1 unit/kg followed by an infusion of 0.1 unit/kg/hr has been used
-If blood glucose has not fallen by 10% in first hour, give bolus of 0.14 units/kg while continuing insulin infusion.

DKA: When blood glucose concentration reaches 200 mg/dL, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain a blood glucose between 150 and 200 mg/dL until resolution of DKA (serum bicarbonate level 15 mEq/L or greater, venous pH greater than 7.3, and a calculated anion gap in the normal range)

HHS: When blood glucose concentration reaches 300 mg/dL or less, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain blood glucose between 250 and 300 mg/dL until resolution of HHS.

Subcutaneous:
-Rapid acting insulin analogs (lispro, aspart, and glulisine) have been used in studies for the treatment of uncomplicated mild to moderate DKA. The following regimens have been used:
-Initial dose of 0.2 unit/kg followed by 0.1 unit/kg every hour subcutaneously until blood glucose decreased below 250 mg/dL, then 0.05 unit/kg every hour until DKA resolved
-Initial dose of 0.3 units/kg followed by 0.2 unit/kg every 2 hours until blood glucose decreased below 250 mg/dL then 0.1 unit/kg every 2 hours until DKA resolved

Comments:
-An endocrinologist or critical care specialist with training and expertise in the management of DKA or HHS should direct care; frequent monitoring of clinical and laboratory parameter is necessary as well as identification and correction of precipitating event.
-Starting insulin therapy before IV fluid replacement may precipitate shock, and increase the risk of hypokalemia and cerebral edema.
-To prevent rebound hyperglycemia, initiate subcutaneous insulin 15 to 30 minutes (rapid-acting) or 1 to 2 hours (regular insulin) before stopping the insulin infusion; alternatively, basal insulin may be administered in the evening and the insulin infusion stopped the next morning.

Use: Treatment of hyperglycemic emergencies.

Usual Adult Dose for Nonketotic Hyperosmolar Syndrome:

Successful treatment of hyperglycemic emergencies such as diabetic ketoacidosis (DKA) and hyperosmolar state (HHS) requires frequent monitoring of clinical and laboratory parameters while carefully correcting volume deficits, managing electrolytes, and normalizing blood glucose. Insulin therapy is used to slowly correct high glucose levels; consult current treatment protocols for specific guidance on fluid and electrolyte management.

Intravenous:
-IV insulin infusion is generally started 1 to 2 hours after initiating fluid replacement therapy
-Dose: 0.14 unit/kg/hour IV; alternatively, a bolus of 0.1 unit/kg followed by an infusion of 0.1 unit/kg/hr has been used
-If blood glucose has not fallen by 10% in first hour, give bolus of 0.14 units/kg while continuing insulin infusion.

DKA: When blood glucose concentration reaches 200 mg/dL, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain a blood glucose between 150 and 200 mg/dL until resolution of DKA (serum bicarbonate level 15 mEq/L or greater, venous pH greater than 7.3, and a calculated anion gap in the normal range)

HHS: When blood glucose concentration reaches 300 mg/dL or less, decrease the insulin infusion to 0.02 to 0.05 unit/kg/hr; dextrose should be added to the IV fluids to maintain blood glucose between 250 and 300 mg/dL until resolution of HHS.

Subcutaneous:
-Rapid acting insulin analogs (lispro, aspart, and glulisine) have been used in studies for the treatment of uncomplicated mild to moderate DKA. The following regimens have been used:
-Initial dose of 0.2 unit/kg followed by 0.1 unit/kg every hour subcutaneously until blood glucose decreased below 250 mg/dL, then 0.05 unit/kg every hour until DKA resolved
-Initial dose of 0.3 units/kg followed by 0.2 unit/kg every 2 hours until blood glucose decreased below 250 mg/dL then 0.1 unit/kg every 2 hours until DKA resolved

Comments:
-An endocrinologist or critical care specialist with training and expertise in the management of DKA or HHS should direct care; frequent monitoring of clinical and laboratory parameter is necessary as well as identification and correction of precipitating event.
-Starting insulin therapy before IV fluid replacement may precipitate shock, and increase the risk of hypokalemia and cerebral edema.
-To prevent rebound hyperglycemia, initiate subcutaneous insulin 15 to 30 minutes (rapid-acting) or 1 to 2 hours (regular insulin) before stopping the insulin infusion; alternatively, basal insulin may be administered in the evening and the insulin infusion stopped the next morning.

Use: Treatment of hyperglycemic emergencies.

Usual Pediatric Dose for Diabetes Type 1:

4 years and older: Individualize dose based on metabolic needs and frequent monitoring of blood glucose
-Use HbA1c values to guide therapy; consult current guidelines for optimal target ranges

Multiple-daily injection (MDI):
-Administer subcutaneously within 15 minutes before a meal or within 20 minutes after starting a meal
-Match prandial insulin dose to carbohydrate intake, pre-meal blood glucose, and anticipated activity
-Use in combination with an intermediate-acting or long-acting basal insulin

Continuous Subcutaneous Infusion (Insulin Pump)
-Initial programming should be based on the total daily insulin dose of previous MDI regimen; check with pump labeling to ensure the pump has been evaluated with this insulin

Intravenous Administration
-Dilute to a concentration of 0.05 to 1 unit/mL in normal saline in an infusion system using polyvinyl chloride (PVC) bags; closely monitor blood glucose and serum potassium during administration

Use: To improve glycemic control in pediatric patients 4 years or older with type 1 diabetes mellitus.

What other drugs will affect insulin glulisine?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of insulin. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

  • Your pharmacist can provide more information about insulin glulisine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.06. Revision Date: 2016-06-22, 2:03:23 PM.

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