Fiasp® (insulin aspart injection) 100 U/mL

Please read the Important Safety Information below

Prescribing Information
NovoCare_Zegalogue_v01

What is ZEGALOGUE®?

ZEGALOGUE® (dasiglucagon) injection 0.6 mg/0.6 mL is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 6 years and older. It is not known if ZEGALOGUE® is safe and effective in children under 6 years of age.

Important Safety Information

Do not use ZEGALOGUE® if you:

  • have a tumor called pheochromocytoma in the gland on top of your kidneys (adrenal gland).
  • have a tumor called insulinoma in your pancreas.

Before using ZEGALOGUE®, tell your healthcare provider about all of your medical conditions, including if you:

  • have a tumor in your pancreas.
  • are allergic to dasiglucagon, or any other ingredients in ZEGALOGUE®.
  • have not had food or water for a long time (prolonged fasting or starvation).
  • have adrenal insufficiency.
  • have low blood sugar that does not go away (chronic hypoglycemia).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if ZEGALOGUE® passes into your breast milk. You and your healthcare provider should decide if you can use ZEGALOGUE® while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use ZEGALOGUE®?

  • Read the detailed Instructions For Use that come with ZEGALOGUE®.
  • Use ZEGALOGUE® exactly how your healthcare provider tells you to use it.
  • Make sure your caregiver knows where you keep your ZEGALOGUE® and how to use ZEGALOGUE® the right way before you need it.
  • Your caregiver must act quickly. Having very low blood sugar for a period of time may be harmful.
  • Your healthcare provider will tell you how and when to use ZEGALOGUE®.
  • After giving ZEGALOGUE® your caregiver should call for emergency medical help right away.
  • Once you are able to safely consume food or drink, your caregiver should give you a fast-acting source of sugar (such as fruit juice) and a long-acting source of sugar (such as crackers with cheese or peanut butter).
  • If you do not respond to treatment after 15 minutes, your caregiver may give you another dose, if available.
  • Tell your healthcare provider each time you use ZEGALOGUE®. Your healthcare provider may need to change the dose of your other diabetes medicines.

What are the possible side effects of ZEGALOGUE®?

ZEGALOGUE® may cause serious side effects, including:

  • high blood pressure. ZEGALOGUE® can cause high blood pressure in certain people with tumors in their adrenal glands.
  • low blood sugar. ZEGALOGUE® can cause certain people with tumors in their pancreas called insulinomas to have low blood sugar.
  • serious allergic reaction. Call your healthcare provider or get medical help right away if you have a serious allergic reaction including: rash, difficulty breathing, low blood pressure (hypotension).

The most common side effects of ZEGALOGUE® include: in adults: nausea, vomiting, headache, diarrhea, and injection site pain; in children: nausea, vomiting, headache, and injection site pain. These are not all the possible side effects of ZEGALOGUE®.

Please see Prescribing Information for ZEGALOGUE®.

 

© 2024 Novo Nordisk  All rights reserved.  US24NC00200  November 2024