Apidra Diabetes Type 1 Treatment - Apidra Patient Information

Brand Names: Apidra
Generic Name: insulin glulisine

Pronounciation: (IN su lin GLOO lis een)

Apidra, insulin glusine, full prescribing information

What is Apidra and what is it prescribed for?

Apidra (insulin glulisine) is a hormone that is produced in the body. It works by lowering levels of glucose (sugar) in the blood. It is a faster-acting form of insulin than regular human insulin.

Apidra is used to treat type 1 (insulin-dependent) diabetes in adults and children who are at least 4 years old. It is usually given together with another long-acting insulin.

Apidra may also be used for other purposes not listed here.

Important information about Apidra

Apidra is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

Take care to keep your blood sugar from getting too low, causing hypoglycemia. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar. Also be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Apidra is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Before using Apidra

Do not use Apidra if you are allergic to insulin, or if you are having an episode of hypoglycemia (low blood sugar).

Before using Apidra, tell your doctor if you have liver or kidney disease.

Tell your doctor about all other medications you use, including any oral (taken by mouth) diabetes medications.

Apidra is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, eye care, dental care, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

FDA pregnancy category C. It is not known whether Apidra is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether insulin glulisine passes into breast milk or if it could harm a nursing baby. Do not use Apidra without telling your doctor if you are breast-feeding a baby.

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How should I use Apidra?

Use Apidra exactly as it was prescribed for you. Do not use it in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Apidra is given as an injection (shot) under your skin using a needle and syringe, an injection pen or insulin pump. It may also be given through a needle placed into a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject Apidra. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Apidra is a fast-acting insulin that begins to work very quickly. You should use it within 15 minutes before or 20 minutes after you start eating a meal.

Apidra should be thin, clear, and colorless. Do not use Apidra if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Choose a different place in your injection skin area each time you use Apidra. Do not inject into the same place two times in a row.

If you use Apidra with an insulin pump, do not mix or dilute Apidra with any other insulin. Call your doctor at once if you think your infusion pump is not working properly.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Some insulin needles can be used more than once, depending on needle brand and type. But a reused needle must be properly cleaned, recapped, and inspected for bending or breakage. Reusing needles also increases your risk of infection. Ask your doctor or pharmacist whether you are able to reuse your insulin needles.

Infusion pump tubing, catheters, and the needle location on your skin should be changed every 48 hours.

Never share an injection pen or cartridge with another person. Sharing injection pens or cartridges can allow disease such as hepatitis or HIV to pass from one person to another.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, or skip meals. These things can affect your glucose levels and your insulin dose needs may also change.

Watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, loss of appetite, increased urination, nausea, vomiting, drowsiness, dry skin, and dry mouth. Check your blood sugar levels and ask your doctor how to adjust your insulin doses if needed.

Ask your doctor how to adjust your Apidra dose if needed. Do not change your dose without first talking to your doctor. Carry an ID card or wear a medical alert bracelet stating that you have diabetes, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are diabetic.

Storing unopened Apidra vials, cartridges or injection pens: Keep in the carton and store in a refrigerator, protected from light. Throw away any insulin not used before the expiration date on the medicine label. Unopened vials, cartridges or injection pens may also be stored at room temperature for up to 28 days, away from heat and bright light. Throw away any insulin not used within 28 days.

Storing after your first use: You may keep "in-use" vials in the refrigerator or at room temperature, protected from light. Use within 28 days.

In-use cartridges or injection pens must be stored at room temperature, away from heat and bright light. Do not refrigerate an in-use cartridge or injection pen. Keep them at room temperature and use within 28 days. An infusion set should be stored at room temperature and used within 48 hours.

Do not freeze Apidra, and throw away the medication if it has become frozen.

What happens if I miss a dose?

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

It is important to keep Apidra on hand at all times. Get your prescription refilled before you run out of insulin completely.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An insulin overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure (convulsions), or coma.

What should I avoid while using Apidra?

Do not change the brand of Apidra or syringe you are using without first talking to your doctor or pharmacist. Avoid drinking alcohol. Your blood sugar may become dangerously low if you drink alcohol while using Apidra. Do not expose Apidra to high heat. Throw the medication away if it becomes hotter than 98 degrees F.

Apidra side effects

Get emergency medical help if you have any of these signs of insulin allergy: itching skin rash over the entire body, wheezing, trouble breathing, fast heart rate, sweating, or feeling like you might pass out.

Hypoglycemia, or low blood sugar, is the most common side effect of Apidra. Symptoms of low blood sugar may include headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, trouble concentrating, confusion, or seizure (convulsions). Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Apidra can also cause hypokalemia (low potassium levels in the blood). Call your doctor at once if you have symptoms such as dry mouth, increased thirst, increased urination, uneven heartbeats, muscle pain or weakness, leg pain or discomfort, or confusion.

Tell your doctor if you have itching, swelling, redness, or thickening of the skin where you inject Apidra.

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.

What other drugs will affect Apidra?

Using certain medicines can make it harder for you to tell when you have low blood sugar. Tell your doctor if you use any of the following:

• albuterol (Proventil, Ventolin);
• clonidine (Catapres);
• guanethidine (Ismelin);
• lanreotide (Somatuline Depot);
• niacin (Niaspan, Niacor, Advicor);
• octreotide (Sandostatin);
• pramlintide (Symlin);
• reserpine; or
• beta-blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol(Inderal, InnoPran), timolol (Blocadren), and others.

There are many other medicines that can increase or decrease the effects of Apidra on lowering your blood sugar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

• Your pharmacist can provide more information about Apidra.
• Remember, keep Apidra and all other medicines out of the reach of children, never share your medicines with others, and use Apidra only for the indication prescribed.

last updated: 02/2009

Apidra, insulin glusine, full prescribing information

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