NovoLOG PenFill

Insulin aspart is a fast-acting type of insulin. Insulin is one of many hormones that help the body turn the food we eat into energy. This is done by using the glucose (sugar) in the blood as quick energy. Also, insulin helps us store energy that we can use later. When you have diabetes mellitus, your body cannot make enough or does not use insulin properly. So, you must take additional insulin to regulate your blood sugar and keep your body healthy. This is very important as too much sugar in your blood can be harmful to your health. Since insulin aspart acts faster than regular human insulin, you normally should use insulin aspart with a longer-acting insulin.

This medicine is available only with your doctor's prescription.

This section provides information on the proper use of a number of products that contain insulin aspart, recombinant. It may not be specific to NovoLOG PenFill. Please read with care.

A nurse or other trained health professional may give you this medicine. You may also be taught how to give your medicine at home. This medicine is given as a shot under your skin or into a vein.

Always double-check both the concentration (strength) of your insulin and your dose. Concentration and dose are not the same. The dose is how many units of insulin you will use. The concentration tells how many units of insulin are in each milliliter (mL), such as 100 units/mL (U-100), but this does not mean you will use 100 units at a time.

Each package of insulin aspart contains a patient information sheet. Read this sheet carefully before beginning treatment and each time you refill for any new information, and make sure you understand:

• How to prepare the medicine.
• How to inject the medicine.
• How to use disposable insulin delivery device.
• How to use external insulin pump.
• How and when to change the infusion set, cartridge adapter, and insulin in the external insulin pump reservoir.
• How to dispose of syringes, needles, and injection devices.

It is best to use a different place on the body for each injection (eg, under the skin of your abdomen or stomach, thigh, buttocks, or upper arm). If you have questions about this, contact a member of your health care team.

When used as a mealtime insulin, insulin aspart should be taken within 5 to 10 minutes before a meal or immediately before a meal.

When used in an insulin pump: Carefully read and follow the external insulin pump instructions. This insulin should not be mixed with any other insulin or diluted when used in an insulin pump. The insulin aspart in the pump should be changed at least every 6 days and the infusion set and insertion site changed at least every 3 days. If you do not understand how you are to use the insulin pump, contact your doctor or pharmacist.

Use a new needle for cartridge or pen each time you give yourself an injection. Always remove and throw the needle after each injection from the pen, and store without a needle attached.

Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

You should never mix insulin aspart with other insulin injections without checking with your doctor first. These injections are usually done separately. If you have questions about this, ask your doctor or pharmacist.

Do not change the brand, type, 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 if it is the correct type of insulin.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For diabetes mellitus:
    • Adults—The dose is based on your blood sugar and must be determined by your doctor.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store unused vials, pens, or cartridges in the refrigerator. Do not freeze. Do not use if the medicine has been frozen. The expiration date on the insulin package tells you how long you can keep the medicine in the refrigerator. Throw the medicine away after the expiration date has passed.

The vial that you are currently using may be kept in the refrigerator or at room temperature in a cool place, away from direct heat and light, for only 28 days.

The cartridge or pen that you are currently using should not be refrigerated. You should store the cartridge or pen at room temperature in a cool place, away from direct heat and light, for only 28 days.

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

Insulin aspart 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 aspart. 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 aspart, you should eat a meal within 5 to 10 minutes.

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

If you use this medicine with an insulin pump, do not mix or dilute insulin aspart with any other insulin. Infusion pump tubing, catheters, and the needle location on your skin should be changed every 3 days. Change the medicine in the reservoir every 6 days.

Never share an injection pen, cartridge, 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 or 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 aspart 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 aspart:

• Refrigerate and use until expiration date; or

• Store at room temperature and use within 28 days.

Storing opened (in use) insulin aspart:

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

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

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

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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

Applies to insulin aspart: subcutaneous solution

Along with its needed effects, insulin aspart (the active ingredient contained in NovoLog PenFill) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking insulin aspart:

• Anxious feeling
• behavior change similar to being drunk
• blurred vision
• cold sweats
• confusion
• convulsions (seizures)
• depression
• difficulty with thinking
• dizziness or lightheadedness
• drowsiness
• excessive hunger
• fast heartbeat
• headache
• irritability or abnormal behavior
• nightmares
• restless sleep
• shakiness
• slurred speech
• tingling in the hands, feet, lips, or tongue

• Depression of the skin at the place of injection
• dryness of the mouth
• fast or weak pulse
• feeling of pressure, itching, redness, soreness, stinging, swelling, or tingling at the place of injection
• increased thirst
• irregular heartbeat
• loss of appetite
• mood or mental changes
• muscle cramps or pain
• nausea or vomiting
• skin rash or itching over the whole body
• sweating
• thickening of the skin at the place of injection
• trouble breathing
• unusual tiredness or weakness