Insulin Aspart (rDNA Origin) Injection

Why is this medicine prescribed?

Insulin aspart injection is used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) and type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood).Insulin aspart is a short-acting, man-made version of human insulin.Insulin aspart works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems.Using medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease.Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Insulin aspart comes as a solution (liquid) and a suspension (liquid with particles) to inject subcutaneously (under the skin).It is injected several times a day, before or after a meal, depending on the product you are using.Your doctor will tell you how much to inject and how often you should inject it.

Use insulin aspart injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Insulin aspart solution may also be injected intravenously (into a vein) by a doctor or nurse in a healthcare setting.A doctor or nurse will carefully monitor you for side effects.

Never use insulin aspart injection when you have symptoms of hypoglycemia (low blood sugar) or if you have checked your blood sugar and it is low.

Insulin aspart controls diabetes but does not cure it. Continue to use insulin aspart injection even if you feel well. Do not stop using insulin aspart injection without talking to your doctor. Do not switch to another brand or type of insulin or change the dose of any type of insulin you are using without talking to your doctor. Always check the insulin label to make sure you received the right type of insulin from the pharmacy.

Before you use insulin aspart injection yourself the first time, read the instructions for use that comes with the medication.Ask your doctor or pharmacist to show you how to inject it. Ask your doctor or pharmacist if you have any questions about injecting insulin aspart.

Insulin aspart comes in vials, prefilled cartridges to be placed in dosing pens, and prefilled dosing pens. Be sure you know what supplies, such as needles, syringes, or pens, you will need to inject your medication.

If your insulin aspart comes in vials, you will need to use syringes to inject your dose. Ask your doctor or pharmacist to show you how to inject insulin aspart using a syringe. Ask your doctor or pharmacist if you have questions about the type of syringe you should use.

If your insulin aspart comes in cartridges, you may need to buy an insulin pen separately. Check the manufacturer's information for the patient to see what type of pen is right for the cartridge size you are using. Carefully read the instructions that come with your pen, and ask your doctor or pharmacist to show you how to use it.

If your insulin aspart comes in pens, be sure to read and understand the manufacturer's instructions.If you are blind or have poor eyesight, do not use this pen without help.

Never reuse needles or syringes and never share needles, syringes, cartridges, or pens.If you are using an insulin pen, always remove the needle right after you inject your dose. Discard needles and syringes in a puncture-resistant container. Ask your doctor or pharmacist how to dispose of the puncture-resistant container.

Your doctor may tell you to mix your insulin aspart solution with another type of insulin (NPH insulin) in the same syringe. Your doctor will tell you exactly how to do this. Ask your doctor if you have any questions about mixing insulin aspart with another type of insulin.

Inject insulin aspart in your thighs, stomach, upper arms, or buttocks.Never inject insulin aspart into a muscle. Use a different site for each injection.Do not inject where the skin is thick, lumpy, tender, bruised, scaly, hard, or into areas of skin where there are scars or skin is damaged.

Always look at your insulin aspart before you inject it.Insulin aspart solution should be clear and colorless.Do not use this type of insulin aspart if it is colored, cloudy, thickened, or contains solid particles.Insulin aspart suspension should appear cloudy or milky after you mix it. Do not use this type of insulin if there are clumps in the liquid or if there are solid white particles sticking to the bottom or walls of the bottle. Do not use any type of insulin after the expiration date printed on the bottle has passed.

Insulin aspart suspension must be rolled gently between your hands to mix before use. Do not shake insulin aspart suspension. Ask your doctor or pharmacist if the type of insulin you are using should be mixed and how you should mix it if necessary.

If you are using insulin aspart with an external insulin pump, read the pump user manual for instructions. Ask your doctor or pharmacist to show you how to use the pump.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What special precautions should I follow?

Before using insulin aspart,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• the following nonprescription or herbal products may interact with insulin aspart injection: Aspirin^® or magnesium salicylate (Doans^®, others). Be sure to let your doctor and pharmacist know that you are using these medications before you start using insulin aspart injection. Do not start these medications while using insulin aspart injection without discussing with your healthcare provider.

• tell your doctor if you have vision problems or if you have or have ever had nerve damage caused by your diabetes; heart failure; or if you have any other medical conditions, including heart, kidney, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using insulin aspart injection, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using insulin aspart injection.

• alcohol may cause a change in blood sugar.Ask your doctor about the safe use of alcoholic beverages while you are using insulin aspart injection.

• ask your doctor what to do if you get sick, experience unusual stress, or change your diet, exercise, or activity schedule.These changes can affect your dosing schedule and the amount of insulin you will need.

• ask your doctor how often you should check your blood sugar. Be aware that hypoglycemia may affect your ability to perform tasks such as driving and ask your doctor if you need to check your blood sugar before driving or operating machinery.

• if you are using an external insulin pump, high blood sugar may occur quickly if the pump stops working properly or if the insulin in the pump is exposed to direct sunlight or temperatures greater than 98.6°F (37°C). High blood sugar may also occur if the tubing leaks, becomes blocked, disconnected, or kinks. Call your doctor immediately, if the problem cannot be found quickly and corrected. Your doctor may tell you to use subcutaneous insulin.

What special dietary instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthful diet, and to eat about the same amounts of the same kinds of food at about the same times each day. Skipping or delaying meals or changing the amount or kind of food you eat can cause problems with your blood sugar control.

What should I do if I forget to take a dose?

Insulin aspart must be injected shortly before or after a meal. If you remember your dose before or shortly after your meal, inject the missed dose right away. If some time has passed since your meal, follow the instructions provided by your doctor or call your doctor to find out whether you should inject the missed dose. Do not inject a double dose to make up for a missed one.

What side effects can this medicine cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Insulin aspart may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• redness, swelling, or itching at the site of the injection
• changes in the feel of your skin, skin thickening (fat build-up), lumps in the skin, or a little depression in the skin (fat breakdown)
• weight gain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency treatment:

• rash and/or itching; shortness of breath; wheezing; or swelling of the face, tongue, or throat
• dizziness, drowsiness, confusion, blurred vision, fast heartbeat, or sweating
• weakness, fatigue, constipation, muscle cramps, or abnormal heartbeat
• large weight gain in a short period of time
• swelling of the arms, hands, feet, ankles, or lower legs

Insulin aspart may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in and out of reach of children. Store insulin aspart vials, cartridges, and pens in the refrigerator. Do not freeze. Opened and unopened vials, cartridges, and pens may also be stored at room temperature, in a cool place that is away from heat and direct sunlight. Check the manufacturer's information to find out how long you may keep insulin aspart injection in the refrigerator or at room temperature. Discard any insulin aspart product that has been exposed to extreme heat or cold.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Insulin aspart overdose can occur if you use too much insulin aspart or if you use the right amount of insulin aspart but eat less than usual or exercise more than usual. Insulin aspart overdose can cause hypoglycemia. If you have symptoms of hypoglycemia, follow your doctor's instructions for what you should do if you develop hypoglycemia. Other symptoms of overdose:

• loss of consciousness
• seizures

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to insulin aspart. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

Brand name(s)

• Fiasp^® (insulin aspart)
• Kristy^® (insulin aspart-xjhz)
• Merilog^® (insulin aspart-szjj)
• NovoLog^® (insulin aspart)
• NovoLog^® Mix 70/30 (insulin aspart protamine and insulin aspart)
• Ryzodeg^® 70/30 (as a combination product containing insulin aspart and insulin degludec)