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).
|ZEGALOGUE N=20||Placebo N=11|
|N is the number of patients who were randomized and treated.|
|Median time to recovery [95% CI *]||10 min [8; 12] †||30 min [20; -)|
Figure 4 Time to plasma glucose recovery in Trial C
ZEGALOGUE injection is a clear, colorless solution supplied as follows:
|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|
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).
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.
Review the Patient Information and Instructions For Use with the patient and family members or caregivers.
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)].
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: |
|Before using ZEGALOGUE, tell your healthcare provider about all of your medical conditions, including if you: |
| How should I use ZEGALOGUE? |
| What are the possible side effects of ZEGALOGUE? ZEGALOGUE may cause serious side effects, including: |
| || |
|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? |
|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 .|
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