What is ZEGALOGUE?
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.
Who should not use ZEGALOGUE?
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
How does ZEGALOGUE work?
ZEGALOGUE is a rescue treatment that helps people with diabetes recover from very low blood sugar when they need help from others. ZEGALOGUE comes in an autoinjector or a prefilled syringe.
How do I use ZEGALOGUE?
- Read the detailed Instructions For Use that come with ZEGALOGUE. Please see autoinjector Instructions For Use and prefilled syringe Instructions For Use
- 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
How was ZEGALOGUE studied?
ZEGALOGUE was studied in a clinical trial program of people with type 1 diabetes. Two trials were conducted in adults, and a third trial was conducted in children and adolescents aged 6 to 17 years. In all 3 trials, the results of participants who received ZEGALOGUE were compared with the results of those who received a placebo following insulin-induced low blood sugar.
The primary goal in all 3 trials was to measure the time to blood sugar recovery, defined as an increase in blood sugar of at least 20 mg/dL from the time of administration, without additional intervention.
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, or low blood pressure (hypotension)
What are the most common side effects of ZEGALOGUE?
In clinical trials, the most common side effects of ZEGALOGUE in adults were nausea, vomiting, headache, diarrhea, and injection site pain.
In clinical trials, the most common side effects of ZEGALOGUE in children and adolescents were nausea, vomiting, headache, and injection site pain.
When do I need ZEGALOGUE?
When you experience very low blood sugar and need help from others, those close to you should administer ZEGALOGUE.
Can I travel with ZEGALOGUE?
ZEGALOGUE should be stored in a refrigerator (36 °F to 46 °F) for up to 3 years until the printed expiration date on the label. Keep away from the cooling element. Do not freeze.
Once removed from refrigeration, ZEGALOGUE can be stored at room temperature (68 °F to 77 °F) for up to a year, or until the original expiration date on the label, whichever comes first. Do not return to the refrigerator after storing at room temperature.
Record the date when the product was removed from the refrigerator in the space provided on the protective case.
Store in the provided protective case and protect from light.
Discard ZEGALOGUE after the end of the 12-month period at room temperature storage, or after the expiration date stated on the product, whichever comes first.