Prescription Drug Information: Zegalogue (Page 3 of 5)

14.2 Pediatric Patients

Trial C, NCT03667053: Pediatric patients aged 6 to 17 years and weighing ≥20 kg, were randomized 2:1:1 to ZEGALOGUE, placebo, and glucagon for injection, stratified by injection sites (abdominal region, thigh) and age groups (6-11 years and 12-17 years). A total of 42 patients were randomized. The mean age was 12.5 years (range 7 to 17 years), and the mean duration of diabetes was 5.9 years; 56% were male; 95% were White. The mean baseline plasma glucose was 72.0 mg/dL. The median time to plasma glucose recovery was statistically significantly shorter for ZEGALOGUE (10 minutes) versus placebo (30 minutes) (Table 5). Figure 4 shows the cumulative proportions of pediatric patients achieving plasma glucose recovery over time. The median time to plasma glucose recovery was numerically similar between ZEGALOGUE (10 minutes) and glucagon for injection (10 minutes).

Table 5 Plasma Glucose Recovery in Pediatric Patients

	Trial C
	ZEGALOGUE N=20	Placebo N=11
N is the number of patients who were randomized and treated.
* log-log confidence interval † p < 0.001 versus placebo (log-rank test stratified by injection site and age group)
Median time to recovery [95% CI *]	10 min [8; 12] †	30 min [20; -)

Figure 4 Time to plasma glucose recovery in Trial C

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

ZEGALOGUE injection is a clear, colorless solution supplied as follows:

Presentation	Strength	Package Size	NDC
Single-dose autoinjector	0.6 mg/0.6 mL	1	80644-0012-1
Single-dose autoinjector	0.6 mg/0.6 mL	2	80644-0012-2
Single-dose prefilled syringe	0.6 mg/0.6 mL	1	80644-0013-1
Single-dose prefilled syringe	0.6 mg/0.6 mL	2	80644-0013-2

16.2 Recommended Storage

Store ZEGALOGUE in a refrigerator, 2°C to 8°C (36°F to 46°F). Keep away from the cooling element. Do not freeze.

ZEGALOGUE can be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 12 months. Record the date when the product was removed from the refrigerator in the space provided on the protective case. Do not return the product to the refrigerator after storing at room temperature. 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 occurs first.

The inside of the gray cap on ZEGALOGUE autoinjector contains dry natural rubber (a derivative of latex).

The inside of the gray needle cover on ZEGALOGUE prefilled syringe contains dry natural rubber (a derivative of latex).

17 PATIENT COUNSELING INFORMATION

Advise the patient and family members or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions For Use).

Recognition of Severe Hypoglycemia

Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.

Administration

Review the Patient Information and Instructions For Use with the patient and family members or caregivers.

Serious Hypersensitivity

Inform patients that allergic reactions can occur with glucagon products like ZEGALOGUE. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].

Manufactured by:
Zealand Pharma A/S, 2860 Søborg, Denmark

This Patient Information has been approved by the U.S. Food and Drug Administration.		Issued:03/2021
Patient Information ZEGALOGUE (ze’ gah log) (dasiglucagon) injection, for subcutaneous use
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.
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. See the end of this Patient Information for a complete list of 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, or low blood pressure (hypotension). The most common side effects of ZEGALOGUE include:
	Adults nausea vomiting headache diarrhea injection site pain	Children nausea vomiting headache injection site pain
These are not all of the possible side effects of ZEGALOGUE. 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 ZEGALOGUE in a refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze ZEGALOGUE. 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 ZEGALOGUE in the red protective case it comes in. Keep ZEGALOGUE and all medicines out of the reach of children.
General information about the safe use of ZEGALOGUE. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZEGALOGUE for a condition for which it was not prescribed. Do not give ZEGALOGUE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ZEGALOGUE that is written for healthcare professionals.
What are the ingredients in ZEGALOGUE? Active ingredient: dasiglucagon, provided as dasiglucagon hydrochloride Inactive ingredients: tromethamine, sodium chloride and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH Marketed by: Zealand Pharma A/S, 2860 Søborg, Denmark For more information go to www.zegalogue.com or call 1-877-501-9342 .