Insulin Aspart, Recombinant (IN-su-lin AS-part, ree-KOM-bi-nant)

Treats diabetes.

Brand Name(s):

Fiasp, Fiasp FlexTouch, Fiasp PenFill, Fiasp PumpCart, Insulin Aspart FlexPen, Insulin Aspart PenFill, NovoLOG, NovoLOG FlexPen, NovoLOG Flexpen, NovoLOG PenFill, Relion NovoLOG, Relion NovoLOG Flexpen

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin (including stomach, thigh, buttocks, or upper arm) or into a vein.
• A nurse or other health provider will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• When used as a mealtime insulin, use Novolog® and Insulin Aspart FlexPen® 5 to 10 minutes before a meal. Inject Fiasp® at the start of a meal or within 20 minutes after starting a meal.
• If you are mixing insulin aspart and a long-acting insulin in the same syringe, always draw up insulin aspart into the syringe first. Then draw up the longer-acting insulin.
• This medicine should be clear and colorless. Do not use it if it is discolored, cloudy or thick, or has particles in it.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not use the exact same spot for each injection.
• Do not inject into skin areas that are tender, bruised, scaly, hard, damaged, thick, or has pits, lumps, or scars.
• Use a new needle and syringe each time you inject your medicine. If you use a syringe, use only the kind that is made for insulin injections. Some insulins must be given with a specific type of syringe or needle. Ask your pharmacist if you are not sure which one to use.
• 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.
• 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.
• 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.
• 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.
• Cartridge or pen: Use a new needle 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.
• Insulin pump:
  • Make sure your pump is meant for a short-acting insulin.
  • Do not mix insulin aspart with other insulins in the pump.
  • Change the insulin solution in the pump reservoir at least every 6 days for Fiasp® or every 7 days for Novolog®. Change the infusion set and infusion site according to the instructions.
  • Keep the pump and pump equipment away from heat and direct light. Heat may increase the temperature of the insulin and prevent it from working as it should.
  • Tell your doctor right away if your insulin pump breaks or leaks. You may need to give yourself injections until your pump is fixed.
• 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 an infusion pump or other device, make sure the insulin is made for that device.
• Missed dose: Call your doctor or pharmacist for instructions.
• Unopened medicine: Store the vials, pens, and cartridges in the refrigerator. You may store the medicine at room temperature for 28 days and 18 days for Fiasp® PumpCart® cartridges. Protect from light. Do not freeze. Do not use the insulin if it has been frozen. Keep away from excessive heat or light. Throw away any unused medicine after 28 days.
• Opened medicine:
  • Prefilled pens and cartridges: Store at room temperature for 28 days and 4 days for Fiasp® PumpCart® cartridges, away from direct heat and light. Do not refrigerate. Throw away any opened pen or cartridge after 28 days.
  • 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.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can change the amount of insulin you need to use and make it harder for you to control your diabetes. Tell your doctor about all other medicines that you are using.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease, or heart failure.
• This medicine may cause the following problems:
  • Low blood sugar
  • Fluid retention or heart failure (when used together with thiazolidinediones [TZD] medicines)
  • Ketoacidosis (high ketones and acid in the blood)
• 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.
• Never share insulin pens, needles, or cartridges with anyone. Sharing these can pass hepatitis virus, HIV, and other illnesses from one person to another.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, fruit-like breath odor, stomach pain, weakness
• Change in how much or how often you urinate, lower back or side pain, painful urination
• Dry mouth, increased thirst, muscle cramps, nausea, vomiting, uneven heartbeat
• Rapid weight gain, swelling in your hands, ankles, or feet, trouble breathing, tiredness
• Shaking, trembling, sweating, fast or pounding heartbeat, lightheadedness, hunger, confusion

If you notice these less serious side effects, talk with your doctor:

• Headache, stuffy or runny nose, sore throat
• Redness, itching, swelling, or any skin changes where the shot is given

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088