Zegalogue 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.

• Use Zegalogue exactly how your healthcare provider tells you to use it.
• Read the detailed Instructions For Use that come with your prescription.
• Make sure your caregiver knows where you keep your auto-injectorn or syringe 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.

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

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. See the end of this page for a complete list of ingredients.
• 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 dasiglucagon 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-thecounter medicines, vitamins, and herbal supplements.

Zegalogue may cause serious side effects, including:

• high blood pressure. Dasiglucagon can cause high blood pressure in certain people with tumors in their adrenal glands.
• low blood sugar. Dasiglucagon 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, or low blood pressure (hypotension).

The most common side effects in adults include:

• nausea
• vomiting
• headache
• diarrhea
• injection site pain

The most common side effects in children include:

• nausea
• vomiting
• headache
• injection site pain

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Zegalogue?

• Store in a refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Zegalogue can also be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 12 months. See example in the Instructions For Use for how to keep track of this 12-month period.
• Do not return Zegalogue to the refrigerator after storing at room temperature.
• Throw away Zegalogue if it has been stored at room temperature for more than 12 months.
• Replace Zegalogue before the expiration date printed on the red protective case.
• Store this medicine in the red protective case it comes in.

Keep all medicines out of the reach of children and pets .

Tell your doctor about all your other medicines, especially:

• indomethacin; or

• warfarin (Coumadin, Jantoven).

This list is not complete. Other drugs may interact with dasiglucagon, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

How to throw away (dispose of) Zegalogue

Put your expired or used auto-injector or syringe in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) autoinjectors, loose needles and syringes in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

• made of a heavy-duty plastic
• can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
• upright and stable during use
• leak-resistant
• properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, you will need to follow your community guidelines for the correct way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used autoinjectors. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit it.
Do not recycle your used sharps disposal container.