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warnings and cautions
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. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE to be effective. Patients with these conditions should be treated with glucose. ( 5.4 ) 5.1 Substantial Increase in Blood Pressure in Patients with Pheochromocytoma ZEGALOGUE is contraindicated in patients with pheochromocytoma because glucagon products may stimulate the release of catecholamines from the tumor [see Contraindications (4) ] . If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure. 5.2 Hypoglycemia in Patients with Insulinoma In patients with insulinoma, administration of glucagon products may produce an initial increase in blood glucose; however, ZEGALOGUE administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. ZEGALOGUE is contraindicated in patients with insulinoma [see Contraindications (4) ] . If a patient develops symptoms of hypoglycemia after a dose of ZEGALOGUE, give glucose orally or intravenously. 5.3 Hypersensitivity and Allergic Reactions Allergic reactions have been reported with glucagon products; these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions. 5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen ZEGALOGUE is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for ZEGALOGUE administration to be effective. Patients with these conditions should be treated with glucose.
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 Zealand Pharma A/S at 1-877-501-9342or 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) ] . Table 1 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 2 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. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to ZEGALOGUE with the incidence of antibodies to other products may be misleading. In clinical trials, 4/498 (<1%) of ZEGALOGUE-treated patients developed treatment-emergent anti-drug antibodies (ADAs). Two patients receiving a single dose of ZEGALOGUE had detectable ADAs to dasiglucagon for at least 14 months after dosing. One ADA-positive patient receiving multiple doses of ZEGALOGUE had ADAs with transient neutralizing activity and with cross-reactivity against native glucagon. Although no safety or efficacy concerns were noted for these ADA-positive subjects, it is unknown whether ADAs may affect pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of the drug [see Clinical Studies (14) ] .
adverse reactions table
<table width="75%" ID="Table1"><caption>Table 1 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 </caption><col width="36%" align="left" valign="top"/><col width="32%" align="center" valign="top"/><col width="32%" align="center" valign="top"/><thead><tr styleCode="Botrule"><th rowspan="2" styleCode="Lrule Rrule">Adverse reaction type</th><th styleCode="Rrule">Placebo (N=53) </th><th styleCode="Rrule">Dasiglucagon (N=116) </th></tr><tr><th align="center" styleCode="Rrule">% of Patients</th><th styleCode="Rrule">% of Patients</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nausea</td><td styleCode="Rrule">4%</td><td styleCode="Rrule">57%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Vomiting</td><td styleCode="Rrule">2%</td><td styleCode="Rrule">25%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Headache</td><td styleCode="Rrule">4%</td><td styleCode="Rrule">11%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Diarrhea</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">5%</td></tr><tr><td styleCode="Lrule Rrule">Injection site pain</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">2%</td></tr></tbody></table>
adverse reactions table
<table width="75%" ID="Table2"><caption>Table 2 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</caption><col width="20%" align="left" valign="top"/><col width="20%" align="center" valign="top"/><col width="20%" align="center" valign="top"/><col width="20%" align="center" valign="top"/><col width="20%" align="center" valign="top"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule">Adverse reaction type</th><th styleCode="Rrule">Placebo (N=11) </th><th styleCode="Rrule">Dasiglucagon Age 6-11 years (N=8) </th><th styleCode="Rrule">Dasiglucagon Age 12-17 years (N=12) </th><th styleCode="Rrule">Dasiglucagon All (N=20) </th></tr><tr><th styleCode="Lrule Rrule"/><th styleCode="Rrule">% of Patients</th><th styleCode="Rrule">% of Patients</th><th styleCode="Rrule">% of Patients</th><th styleCode="Rrule">% of Patients</th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Nausea</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">25%</td><td styleCode="Rrule">92%</td><td styleCode="Rrule">65%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Vomiting</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">25%</td><td styleCode="Rrule">67%</td><td styleCode="Rrule">50%</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Headache</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">17%</td><td styleCode="Rrule">10%</td></tr><tr><td styleCode="Lrule Rrule">Injection site pain</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">0%</td><td styleCode="Rrule">8%</td><td styleCode="Rrule">5%</td></tr></tbody></table>