Fiasp® (insulin aspart injection) 100 U/mL

Please read the Important Safety Information below

Prescribing Information
NovoCare_NovoLogMix_v01

What is NovoLog® Mix 70/30?

  • NovoLog® Mix 70/30 (insulin aspart protamine and insulin aspart) injectable suspension 100 U/mL is a man-made insulin used to control high blood sugar in people with diabetes mellitus.
  • It is not known if NovoLog® Mix 70/30 is safe and effective in children.

Important Safety Information

Do not share your NovoLog® Mix 70/30 FlexPen® with other people, even if the needle has been changed. Do not share needles or syringes with another person. You may give other people a serious infection, or get a serious infection from them.

Who should not take NovoLog® Mix 70/30?

  • Do not take NovoLog® Mix 70/30 if you are having an episode of low blood sugar (hypoglycemia) or you have an allergy to NovoLog® Mix 70/30 or any of its ingredients.

Before taking NovoLog® Mix 70/30, tell your healthcare provider about all your medical conditions including, if you are:

  • pregnant, planning to become pregnant, or are breastfeeding.
  • taking new prescription or over-the-counter medicines, including supplements.

Before you start taking NovoLog® Mix 70/30, talk to your health care provider about low blood sugar and how to manage it.

How should I take NovoLog® Mix 70/30?

  • Read the Instructions for Use and take exactly as directed by your healthcare provider.
  • NovoLog® Mix 70/30 starts acting fast. If you have type 1 diabetes, inject within 15 minutes before you eat a meal. Do not inject NovoLog® Mix 70/30 if you are not planning to eat within 15 minutes. If you have type 2 diabetes, you may inject up to 15 minutes before or after starting your meal.
  • Do not mix NovoLog® Mix 70/30 with other insulin products or use in an insulin pump.
  • Know the type and strength of your insulin. Do not change your insulin type unless your health care provider tells you to.
  • Check your blood sugar levels. Ask your health care provider what your blood sugar levels should be and when you should check them.
  • Do not reuse or share your needles or syringes with other people. You may give other people a serious infection, or get a serious infection from them.
  • NovoLog® Mix 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs, or upper arms.
  • Change (rotate) your injection sites within the area you choose with each injection to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. 
    • Do not use the exact same spot for each injection.
    • Do not inject where the skin has pits, is thickened, or has lumps.
    • Do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin.

What should I avoid while taking NovoLog® Mix 70/30?

  • Do not drive or operate heavy machinery, until you know how NovoLog® Mix 70/30 affects you.
  • Do not drink alcohol or use medicines that contain alcohol.

What are the possible side effects of NovoLog® Mix 70/30?

Serious side effects can lead to death, including:

Low blood sugar (hypoglycemia). Some signs and symptoms include:

  • Dizziness, light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heart rate, anxiety, irritability, mood changes, and hunger.

Your insulin dose may need to change because of:

  • weight gain or loss, increased stress, illness, or change in diet or level of physical activity.

Other common side effects may include:

  • low potassium in your blood (hypokalemia), reactions at the injection site, itching, rash, serious allergic reactions (whole body reactions), skin thickening or pits at the injection site (lipodystrophy), weight gain, and swelling of your hands and feet.

Get emergency medical help if you have:

  • trouble breathing, shortness of breath, fast heartbeat, swelling of your face, tongue, or throat, sweating, extreme drowsiness, dizziness, or confusion.

Please see Prescribing Information for NovoLog® Mix 70/30.

NovoLog® Mix 70/30 is a prescription medication.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

 

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