Pronunciation:

IN-su-lin AS-part, ree-KOM-bi-nant

Brand Names:

• NovoLOG
• NovoLOG FlexPen
• NovoLOG PenFill

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antidiabetic

Pharmacologic—

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:

Allergies—

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Fiasp®, Insulin Aspart FlexPen®, and Novolog® in children. However, safety and efficacy of insulin aspart mix 50/50 and mix 70/30 in the pediatric population have not been established.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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.

• Abiraterone Acetate
• Bexagliflozin
• Chloroquine
• Chlorothiazide
• Chlorthalidone
• Ciprofloxacin
• Delafloxacin
• Enoxacin
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Lanreotide
• Levofloxacin
• Liraglutide
• Lomefloxacin
• Macimorelin
• Metoclopramide
• Metolazone
• Metreleptin
• Moxifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pioglitazone
• Polythiazide
• Pramlintide
• Rosiglitazone
• Semaglutide
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Thioctic Acid
• Triamterene
• Trovafloxacin

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.

• Acebutolol
• Albiglutide
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Dulaglutide
• Esmolol
• Exenatide
• Fenugreek
• Glucomannan
• Guar Gum
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lixisenatide
• Methylene Blue
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Ozanimod
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tranylcypromine

Other interactions—

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.

• Ethanol

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:

• Heart disease or
• Heart failure or
• Hypokalemia (low potassium in the blood)—Use with caution. May make these conditions worse and increase your chance of having serious side effects.

• Hypoglycemia (low blood sugar)—Should not be used during episodes of hypoglycemia. If you have low blood sugar and take insulin, your blood sugar may reach dangerously low levels.

• Infection or any illness or
• Stress (eg, physical or emotional)—These conditions could change blood sugar and may change 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 (eg, stomach, thigh, buttocks, or upper arm) or into a vein.

Always check the label before use, to make sure you have the correct type of insulin. Do not change the brand, type, or concentration unless your doctor tells you to. If you use a pump or other device, make sure the insulin is made for that device.

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 leaflet and patient instructions. Read this leaflet carefully 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.

Do not inject into skin areas that are tender, bruised, scaly, hard, damaged, thick, or has pits, lumps, or scars.

This medicine should be clear and colorless. Do not use it if it is discolored, cloudy or thick, or has particles in it.

When used as a mealtime insulin, Novolog® and Insulin Aspart FlexPen® should be taken within 5 to 10 minutes before a meal or immediately before a meal. Take Fiasp® at the start of a meal or within 20 minutes after starting 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 Fiasp® and 7 days for Novolog® and the infusion set and insertion site changed according to the instructions. If you do not understand how you are to use the insulin pump, contact your doctor or pharmacist.

Use a new needle for the 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.

When injecting the Fiasp® FlexTouch® pen or Insulin Aspart FlexPen®, slowly count to 6 before removing it from the skin to get your full dose of the medicine.

To use the Penfill® Cartridge:

• Wash your hands with soap and water.
• Prime the pen by removing the air from the needle and cartridge until you see insulin at the needle tip. If you do not see a drop of insulin after 6 times, change the needle and repeat this step.
• You should see a "0" in the dose window. Turn the dose selector clockwise to select the dose you need to inject.
• Insert the needle into your skin and push the dose button all the way in. If you see "0" in the dose window, continue to hold it, then slowly count to 6 before removing it.
• Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Store the pen without a needle attached. Do not use the pen if it is broken or damaged.

To use the FlexPen® or FlexTouch® Pen:

• Wash your hands with soap and water.
• Prime the pen by removing the air from the needle and cartridge. Select 2 units when turning the dose knob.
• Hold the pen with the needle pointing up, then gently tap the cartridge holder to collect the air bubbles at the top.
• Press the push-button until it stops. You should see a "0" in the dose window.
• You should see insulin at the needle tip. If you do not see insulin, repeat the priming steps but not more than 6 times. If there is still no insulin, do not use the pen.
• Turn the dose selector, be careful not to press the push-button.
• Insert the needle into your skin and press the push-button all the way in for at least 6 seconds. Keep pressing until the needle has been pulled out from the skin. This will make sure that you have received the full dose.
• Use a new needle each time you give yourself an injection. Always remove and throw the needle after each injection. Store the pen without a needle attached. Do not use the pen if it is broken or damaged.

To use the PumpCart® Cartridge:

• Wash your hands with soap and water before installing the cartridge in the insulin pump.
• Carefully read and follow the insulin pump instructions.
• Replace the cartridge in the pump at least every 4 days, or according to the insulin pump instructions, whichever is shorter. Change the infusion set and infusion site according to the instructions.
• Do not mix insulin aspart with other insulins in the pump. Do not use the cartridge in an insulin pen.
• Do not use the cartridge if there is damage or leaks, if the plunger has moved, or if the bottom of the plunger is visible above the white label band.

To use the vial:

• Wash your hands with soap and water.
• Use only syringes that are made for insulin injections. Use a new syringe and needle each time you give yourself an injection.
• Do not mix this medicine with any other insulin.

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.

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:
    • Fiasp®:
      • Adults—The dose is based on your blood sugar and must be determined by your doctor.
      • Children—The dose is based on your blood sugar and must be determined by your doctor.
    • Insulin Aspart FlexPen®:
      • Adults—The dose is based on your blood sugar and must be determined by your doctor.
      • Children—The dose is based on your blood sugar and must be determined by your doctor.
    • Novolog®:
      • 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.

Unopened medicine: Store the vials, pens, and cartridges in the refrigerator. You may store the medicine at room temperature for 28 days. Protect from light. Do not freeze. Do not use the insulin if it has been frozen. Throw away any unused medicine after 28 days.

Opened pens and cartridges: Store at room temperature, away from direct heat and light. Do not refrigerate. Throw away any opened pen or cartridge after 28 days.

Opened vials: Store in the refrigerator or at room temperature in a cool place, away from sunlight and heat. Use within 28 days. If it is used together with a pump, throw away opened vials after 19 days.

Store unused vials, pens, PenFill cartridges, or PumpCart® cartridges in the refrigerator. You may store the medicine at room temperature for 28 days for vials, pens, or PenFill cartridges, and 18 days for PumpCart® cartridges. Do not freeze. Do not use if the medicine has been frozen. Keep away from excessive heat or light. 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.

Store opened vials, pens, or PenFill® cartridges for 28 days and PumpCart® cartridges for 4 days at room temperature, away from direct heat and light. You may also store opened vials and pens for 28 days. Do not refrigerate opened PenFill® cartridges and PumpCart® cartridges. Throw away any opened pen or cartridge after 28 days.

Throw away used syringes and needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits especially during the first few weeks you use this medicine. Blood tests may be needed to check for unwanted effects.

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.

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.

Too much insulin aspart can cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you use insulin aspart with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat because of nausea or vomiting or have diarrhea. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, depression, difficulty in thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or abnormal behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household should also know how to use it.

This medicine may make you dizzy, drowsy, or less alert than you are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

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.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine or insulin, changes in insulin regimen, you overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination, ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, trouble breathing (rapid and deep), unconsciousness, and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

This medicine may cause low levels of potassium in your blood. Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.

Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination.

Using this medicine together with other diabetes medicine (eg, thiazolidinedione [TZD] medicine) may cause serious heart problem or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having, chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Side Effects of This Medicine:

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:

More common

Anxiety

behavior change similar to being drunk

bladder pain

bloody or cloudy urine

blurred vision

cold sweats

confusion

depression

difficult, burning, or painful urination

difficulty with thinking

dizziness or lightheadedness

drowsiness

excessive hunger

fast heartbeat

frequent urge to urinate

headache

irritability or abnormal behavior

lower back or side pain

nightmares

restless sleep

seizures

shakiness

slurred speech

tingling in the hands, feet, lips, or tongue

Less common

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

skin rash or itching over the whole body

sweating

thickening of the skin at the place of injection

trouble breathing

unusual tiredness or weakness

vomiting

Rare

Bloating or swelling of the face, arms, hands, lower legs, or feet

difficulty in breathing or swallowing

rapid weight gain

redistribution or accumulation of body fat

swelling of the face, throat, or tongue

unusual weight gain or loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Back pain

body aches or pain

chills

cough

diarrhea

ear congestion

fever

loss of voice

muscle aches

sneezing

sore throat

stuffy or runny nose

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.