ZEGALOGUE

Absorption ZEGALOGUE absorption following subcutaneous injection of 0.6 mg resulted in a mean peak plasma concentration of 5110 pg/mL (1510 pmol/L) at around 35 minutes.

DistributionThe mean apparent volume of distribution was 47 L to 57 L following subcutaneous administration.

EliminationThe half-life was approximately 30 minutes.

MetabolismMetabolism data indicated that dasiglucagon is cleared like native glucagon through proteolytic degradation pathways in blood, liver, and kidney. Specifi...

Three randomized, double-blind, placebo-controlled, multicenter trials were conducted in patients with type 1 diabetes. Two trials (Trial A and Trial B) were conducted in adult patients, and one trial (Trial C) was conducted in pediatric patients aged 6 to 17 years. In all 3 trials, patients were randomized to ZEGALOGUE 0.6 mg, placebo, or (in Trials A and C) glucagon for injection 1.0 mg. ZEGALOGUE and the comparators were administered as single subcutaneous injections following a controlled induction of hypoglycemia using intravenous administration of insulin. During this procedure, a plasma...

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/medw...

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 )

• Substantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because ZEGALOGUE may stimulate the release of catecholamines from the tumor. ( 4 , 5.1 )
• Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose, but ZEGALOGUE may stimulate exaggerated insulin release from an insulinoma and cause subsequent hypoglycemia. If a patient develops symptoms of hy...

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 Impac...