Insulin aspart, recombinant (Intravenous, Subcutaneous)

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. It does this by using the glucose (sugar) in the blood for quick energy. Insulin also helps store energy for later use. If you have diabetes mellitus, your body either cannot make enough insulin or does not use it properly. Therefore, you need to take extra insulin to manage your blood sugar and maintain your health. This is very important because having too much sugar in your blood can be harmful. Since insulin aspart works faster than regular human insulin, you usually should use it along with a longer-acting insulin.

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

It is very important for your doctor to 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 by 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 carefully follow 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 while 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 changes in diabetes medicine dosing that might happen because of lifestyle changes, such as changes in exercise and diet. Additionally, counseling on contraception and pregnancy may be needed because of the issues that can arise 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. Allow for changes in time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency: There may be times 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 you have diabetes and lists all of your medicines.
• Keep an extra supply of insulin aspart and syringes with needles or injection devices on hand in case your blood sugar gets too high.
• 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. Regularly check and replace any expired kits.

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, or 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 happen if you use insulin aspart with another antidiabetic medicine, change your insulin regimen (e.g., insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, drink alcohol, or cannot eat due to 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 changes similar to being drunk, blurred vision, cold sweats, confusion, depression, difficulty 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 normal. 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, change your insulin regimen, 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, a 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, fluids, 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 medicines (e.g., thiazolidinedione [TZD] medicine) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, experiencing chest pain or discomfort, extreme tiredness or weakness, trouble breathing, an uneven heartbeat, or excessive swelling of the hands, wrists, ankles, or feet.

In deciding to use a medicine, you and your doctor must consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies to date have not shown any specific problems that would limit the use of Fiasp®, Insulin Aspart FlexPen®, and Novolog® in children. However, the safety and effectiveness of insulin aspart mix 50/50 and mix 70/30 in children have not been established.

Geriatric

While appropriate studies on the effects of insulin aspart in older adults have not been conducted, there are no expected problems that would limit its usefulness in the elderly. However, older patients are more likely to have age-related heart, liver, or kidney issues, which may require a dose adjustment for insulin aspart.

Breast Feeding

There are no adequate studies in women to determine the risks to infants while using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if an interaction may occur. In such cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are significant but not exhaustive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acarbose
• Alogliptin
• Bexagliflozin
• Bromocriptine
• Canagliflozin
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Ciprofloxacin
• Dapagliflozin
• Delafloxacin
• Empagliflozin
• Enoxacin
• Ertugliflozin
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Lanreotide
• Levofloxacin
• Linagliptin
• Liraglutide
• Lomefloxacin
• Macimorelin
• Metformin
• Metoclopramide
• Metolazone
• Metreleptin
• Miglitol
• Moxifloxacin
• Nateglinide
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pioglitazone
• Polythiazide
• Pramlintide
• Repaglinide
• Rosiglitazone
• Semaglutide
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Triamterene
• Trovafloxacin
• Vildagliptin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust 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
• Tirzepatide
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around mealtime or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are significant but not exhaustive.

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 adjust the dose or how often you use this medicine, or provide special instructions regarding food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Heart disease or
• Heart failure or
• Hypokalemia (low potassium in the blood)—Use with caution. May worsen these conditions and increase the risk of 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 drop to dangerously low levels.

• Infection or any illness or
• Stress (e.g., physical or emotional)—These conditions could affect blood sugar levels and the amount of insulin aspart you need.

• Kidney disease or
• Liver disease—Use with caution. The effects of insulin aspart may be stronger due to slower elimination from the body.

Along with its intended effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor right away if you experience any of the following side effects:

More common

• Anxiety
• behavior change similar to being drunk
• bladder pain
• bloody or cloudy urine
• blurred vision
• cold sweats
• confusion
• depression
• painful urination that is difficult, burning, or painful
• difficulty 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

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

Rare

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• difficulty 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 happen that usually do not need medical attention. These side effects may go away as your body gets used to the medicine. Your healthcare professional may also have ways to help prevent or lessen some of these side effects. Check with your healthcare 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 can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• NovoLOG
• NovoLOG FlexPen
• NovoLOG PenFill

Available Dosage Forms:

• Solution

Therapeutic Class: Antidiabetic

Pharmacologic Class: Insulin, Ultra Rapid Acting

Find detailed information on biosimilars for this medication.

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.

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