Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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 were 7 to 11 years old, and 12 were 12 to 17 years old [see Clinical Studies (14) ] .
Adverse Reactions Occurring ≥2% and More Frequently than with Placebo in ZEGALOGUE-treated Adult Patients within 12 hours of Treatment in 2 Placebo-Controlled Trials Adverse reaction type Placebo (N=53) Dasiglucagon (N=116) % of Patients % of Patients Nausea 4% 57% Vomiting 2% 25% Headache 4% 11% Diarrhea 0% 5% Injection site pain 0% 2% Table
Adverse Reactions Occurring ≥2% and More Frequently than with Placebo in ZEGALOGUE-treated Pediatric Patients within 12 hours of Treatment in a Placebo-Controlled Trial Adverse reaction type Placebo (N=11) Dasiglucagon Age 6-11 years (N=8) Dasiglucagon Age 12-17 years (N=12) Dasiglucagon All (N=20) % of Patients % of Patients % of Patients % of Patients Nausea 0% 25% 92% 65% Vomiting 0% 25% 67% 50% Headache 0% 0% 17% 10% Injection site pain 0% 0% 8% 5% Other Adverse Reactions Other adverse reactions in patients treated with dasiglucagon occurring within 12 hours of treatment include: hypertension, hypotension, bradycardia, presyncope, palpitations, and orthostatic intolerance.
6.2 Immunogenicity As with all therapeutic peptides, there is a potential for immunogenicity with ZEGALOGUE.
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
5 WARNINGS AND PRECAUTIONS • 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 hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously.
( 4 , 5.2 ) • Hypersensitivity and Allergic Reactions: Allergic reactions have been reported with glucagon products and may include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension.
( 5.3 ) • Lack of Efficacy in Patients with Decreased Hepatic Glycogen: ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present.
Like all medications, Zegalogue can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: