Effective as of March, 2021.
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Reservation of Rights
What is ZEGALOGUE?
ZEGALOGUE (dasiglucagon) injection is a prescription medicine used to treat very low blood sugar (severe hypoglycemia) in people with diabetes aged 6 years and older.
IMPORTANT SAFETY INFORMATION
INDICATION AND IMPORTANT SAFETY INFORMATION
What is ZEGALOGUE?
ZEGALOGUE (dasiglucagon) injection 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.