Apidra (Insulin Glulisine (Cartridges and Pens))

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the fatty part of the skin.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before use.
• Take 15 minutes before or within 20 minutes after starting a meal.
• Move site where you give the shot each time.
• Do not give into red or irritated skin.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Follow the diet and workout plan that your doctor told you about.
• Be sure you know what to do if you do not eat as much as normal or if you skip a meal.
• Do not use out dated insulin.

What do I do if I miss a dose?

• Be sure you know what to do if you forget to take a dose
• If you are not sure what to do if you miss a dose, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Very bad irritation where the shot was given.
• Change in eyesight.
• Chills.
• Very bad dizziness or passing out.
• Mood changes.
• Bad dreams.
• Not able to sleep.
• Seizures.
• Slurred speech.
• A burning, numbness, or tingling feeling that is not normal.
• Trouble walking.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Change in skin to thick or thin where the shot was given.
• Low blood sugar may occur. Signs may be dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating. Call the doctor right away if any of these signs occur. Follow what you have been told to do if low blood sugar occurs. This may include taking glucose tablets, liquid glucose, or some fruit juices.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where the shot is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

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.

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.

Use with caution; frequent glucose monitoring and insulin dose reduction may be required

Use with caution; frequent glucose monitoring and insulin dose reduction may be required