Insulin aspart, recombinant (Subcutaneous route)
IN-su-lin AS-part, ree-KOM-bi-nant
- NovoLOG FlexPen
- NovoLOG PenFill
Insulin, Ultra Rapid Acting
Uses of This Medicine:
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.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of insulin aspart in children. However, safety and efficacy of insulin aspart mix 50/50 and 70/30 in the pediatric population have not been established.
Although appropriate studies on the relationship of age to the effects of insulin aspart have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of insulin aspart in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems which may require an adjustment in the dose for patients receiving insulin aspart.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Thioctic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Bitter Melon
- Guar Gum
- Methylene Blue
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Hypoglycemia (low blood sugar)—Should not be used in patients with this condition. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.
- Hypokalemia (low potassium in the blood)—May make this condition worse and increase your chance of having serious side effects.
- Infection or any illness or
- Stress (eg, physical or emotional)—These conditions increase blood sugar and may increase the amount of insulin aspart you need.
- Kidney disease or
- Liver disease—Use with caution. The effects of insulin aspart may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
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.
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.
- For diabetes mellitus:
Call your doctor or pharmacist for instructions.
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.
Precautions While Using This Medicine:
Never share insulin pens or cartridges with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.
Your doctor will want to check your progress at regular visits, especially during the first few weeks you take this medicine. Blood tests may be needed to check for unwanted effects.
It is very important to follow carefully any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines during the time you are taking insulin aspart unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
In case of emergency: There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:
- Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
- Keep an extra supply of insulin aspart and syringes with needles or injection devices on hand in case high blood sugar occurs.
- Keep some kind of quick-acting sugar handy to treat low blood sugar.
- Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.
Insulin aspart may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing or swallowing, or chest pain after you get the injection.
You may have some skin redness, rash, itching, or swelling at the injection site. If this irritation is severe or does not go away, call your doctor. Do not inject insulin aspart into a skin area that is red, swollen, or itchy.
Using this medicine together with other diabetes medicine (eg, pioglitazone, rosiglitazone, Actos®, Actoplus Met®, Avandia®) may cause serious heart problem or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having shortness of breath, chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.
Too much insulin aspart can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use insulin aspart with another antidiabetic medicine, delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.
Side Effects of This Medicine:
- More common
- Anxious feeling
- behavior change similar to being drunk
- blurred vision
- cold sweats
- convulsions (seizures)
- difficulty with thinking
- dizziness or lightheadedness
- excessive hunger
- fast heartbeat
- irritability or abnormal behavior
- restless sleep
- slurred speech
- tingling in the hands, feet, lips, or tongue
- Less common or rare
- 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
- thickening of the skin at the place of injection
- trouble breathing
- unusual tiredness or weakness
Along with its needed effects, a medicine 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:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017