Zegalogue .6 mg/.6mL
dasiglucagon · INJECTION, SOLUTION · Novo Nordisk
Zegalogue is a prescription injection used to treat severe low blood sugar (hypoglycemia) in people with diabetes. It belongs to a class of medications called antihypoglycemic agents that work to quickly raise blood sugar levels.
Key Facts
- Brand Name
- Zegalogue
- Generic Name
- dasiglucagon
- NDC Code (Product)
0169-1913- Manufacturer
- Novo Nordisk
- Strength
- .6 mg/.6mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA214231
- Drug Class
- Antihypoglycemic Agent [EPC]
- Marketing Start
- 06/26/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE ZEGALOGUE ® is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. ZEGALOGUE is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only. ( 2.1 ) • The dose in adults and pediatric patients aged 6 years and older is 0.6 mg. ( 2.2 ) • Administer ZEGALOGUE according to the printed instructions on the protective case label and the Instructions For Use. ( 2.1 ) • Visually inspect ZEGALOGUE prior to administration. The solution should appear clear, colorless, and free from particles. If the solution is discolored or contains particulate matter, do not use. ( 2.1 ) • Administer the injection into the lower abdomen, buttocks, thigh, or outer upper arm. ( 2.1 ) • Call for emergency assistance immediately after administering the dose. ( 2.1 ) • If there has been no response after 15 minutes, an additional dose of ZEGALOGUE from a new device may be administered while waiting for emergency assistance. ( 2.1 ) • When the patient has responded to treatment, give oral carbohydrates. ( 2.1 ) • Do not attempt to reuse ZEGALOGUE. Each device contains a single dose of dasiglucagon and cannot be reused. ( 2.1 ) 2.1 Administration Instructions ZEGALOGUE autoinjector and prefilled syringe are for subcutaneous injection only. In…
Contraindications
4 CONTRAINDICATIONS ZEGALOGUE is contraindicated in patients with: • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warnings and Precautions (5.1) ] • Insulinoma because of the risk of hypoglycemia [see Warnings and Precautions (5.2) ] Pheochromocytoma ( 4 ) Insulinoma ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Table 3. Clinically Significant Drug Interactions with ZEGALOGUE Beta-Blockers Clinical Impact: Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given ZEGALOGUE. Indomethacin Clinical Impact: In patients taking indomethacin, ZEGALOGUE may lose its ability to raise blood glucose or may even produce hypoglycemia. Warfarin Clinical Impact: ZEGALOGUE may increase the anticoagulant effect of warfarin. • Beta-blockers: Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7 ) • Indomethacin: In patients taking indomethacin, ZEGALOGUE may lose its ability to raise blood glucose or may produce hypoglycemia. ( 7 ) • Warfarin: ZEGALOGUE may increase the anticoagulant effect of warfarin. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in the labeling: • Hypersensitivity and Allergic Reactions [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥2%) associated with ZEGALOGUE are: Adults: nausea, vomiting, headache, diarrhea, and injection site pain Pediatrics: nausea, vomiting, headache, and injection site pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc., at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of ZEGALOGUE cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, 316 adult patients with type 1 diabetes and 20 pediatric patients with type 1 diabetes were exposed to ZEGALOGUE. The data in Table 1 reflect exposure of 116 adult patients to ZEGALOGUE in 2 placebo-controlled trials (mean age 40 years). Table 2 reflects exposure of 20 pediatric patients exposed to ZEGALOGUE in a placebo-controlled trial. Eight patients …
Frequently Asked Questions
What is Zegalogue used for?
Zegalogue is a prescription injection used to treat severe low blood sugar (hypoglycemia) in people with diabetes. It belongs to a class of medications called antihypoglycemic agents that work to quickly raise blood sugar levels.
Is Zegalogue a controlled substance?
Zegalogue is not classified as a controlled substance by the DEA.
What is the generic name for Zegalogue?
The generic name for Zegalogue is dasiglucagon. There are no other listed brand versions of dasiglucagon.
What is the NDC code for Zegalogue .6 mg/.6mL?
The NDC (National Drug Code) for Zegalogue .6 mg/.6mL is 0169-1913, listed by Novo Nordisk.
Other Zegalogue Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)