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Insulin Aspart, Recombinant (Injection) (Injectable)

(NOVOLOG FLEXPEN)
Insulin Aspart, Recombinant (By injection)
Insulin Aspart, Recombinant (IN-su-lin AS-part, ree-KOM-bi-nant)Treats diabetes.
NovoLOG , NovoLOG FlexPen , NovoLOG PenFill

When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to insulin aspart.

How to Use This Medicine:
Injectable

  • Your healthcare provider will work with you to personalize your dose and treatment based on your insulin needs and lifestyle. You will be taught how to give yourself the injections. Make sure you understand all instructions. Ask the doctor, nurse, or pharmacist if you have questions.
  • 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.
  • Use this medicine 5 to 10 minutes before 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.
  • Do not use the medicine if it is cloudy or thick.
  • 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.
  • Vial: Use only syringes that are made for insulin injections. Use a new syringe each time you give yourself an injection.
  • Cartridge or pen: Use a new needle each time you give yourself an injection.
  • 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. Change the infusion set and infusion site at least every 3 days.
    • 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.
  • Keep all medicine away from heat and direct light. Throw away any medicine that is past the expiration date.
  • Unopened containers (vial, pen, or cartridge):
    • Store in the refrigerator. Do not freeze. The insulin will keep until the expiration date when it is stored in the refrigerator.
    • You may store the container at room temperature for up to 28 days.
  • Opened containers:
    • Vials: Store in the refrigerator or at room temperature for up to 28 days.
    • Cartridge or pen: Store at room temperature in a cool place for up to 28 days. Do not refrigerate an opened cartridge or pen.
  • 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 or low potassium levels in the blood
    • Fluid retention or heart failure (when used together with thiazolidinediones [TZD] medicines)
  • Never share insulin pens, needles, or cartridges with anyone. Sharing these can pass hepatitis virus, HIV, and other illnesses from one person to another.
  • 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
  • Dry mouth, increased thirst, muscle cramps, nausea or 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:

  • 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