FDA

Glucagon

Approved 8 May 2015Intramuscular, IntravenousPowder

The FDA lists this product in 6 strengths and forms.

Indications

Glucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ( 1.1 ) as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients ( 1.2 )

1.1 Severe Hypoglycemia Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.

1.2 Diagnostic Aid Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

Contraindications

Glucagon for Injection is contraindicated in patients with: Pheochromocytoma [see Warnings and Precautions ( 5.1 )] Insulinoma [see Warnings and Precautions ( 5.2 )] because of the risk of hypoglycemia Known hypersensitivity to glucagon or any of the excipients in Glucagon for Injection. Allergic reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension [see Warnings and Precautions ( 5.3 )] Glucagonoma [see Warnings and Precautions ( 5.8 )] because of risk of hypoglycemia when used as a diagnostic aid Pheochromocytoma ( 4 ) Insulinoma ( 4 ) Known hypersensitivity to glucagon or to any of the excipients ( 4 ) Glucagonoma when used as a diagnostic aid ( 4 )

Warnings and precautions

Catecholamine Release in Patients with Pheochromocytoma : Contraindicated in patients with pheochromocytoma because Glucagon for Injection 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; however, Glucagon for Injection may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia.

Indications

1.1 Severe Hypoglycemia Glucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.

1.2 Diagnostic Aid Glucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.

Contraindications

Warnings and precautions

Interactions

Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7.1 ) Indomethacin: In patients taking indomethacin Glucagon for Injection may lose its ability to raise glucose or may produce hypoglycemia. (7.2) Anticholinergic drugs: Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended. (7.3) Warfarin: Glucagon for Injection may increase the anticoagulant effect of warfarin.

(7.4) Insulin: Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin. (7.5)

7.1Table 3: Clinically Significant Drug Interactions with Glucagon for Injection Beta-Blockers Clinical Impact:

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given Glucagon for Injection. Intervention: The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. Indomethacin Clinical Impact: In patients taking indomethacin, Glucagon for Injection may lose its ability to raise blood glucose or may even produce hypoglycemia. Intervention: Monitor blood glucose levels during glucagon treatment of patients taking indomethacin.

Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs and Glucagon for Injection increases the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. Intervention: Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended. Warfarin Clinical Impact: Glucagon for Injection may increase the anticoagulant effect of warfarin.

Intervention: Monitor patients for unusual bruising or bleeding, as adjustments in warfarin dosage may be required. Insulin Clinical Impact: Insulin acts antagonistically to glucagon. Intervention: Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin.

Adverse reactions

The following important adverse reactions are described below and elsewhere in the labeling: Hypersensitivity and Allergic Reactions [see Warnings and Precautions ( 5.3 )] Necrolytic Migratory Erythema [see Warnings and Precautions ( 5.5 )] Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid [see Warnings and Precautions ( 5.6 )] Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when Used as a Diagnostic Aid [see Warnings and Precautions ( 5.7 )] Most common adverse reactions ( >5% or greater incidence): Injection site swelling, injection site erythema, vomiting, nausea, decreased blood pressure, asthenia, headache, dizziness, pallor, diarrhea, and somnolence.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in clinical trials of another drug and may not reflect the rates observed in practice. In a randomized single-blind clinical study of Glucagon for Injection, 29 healthy subjects received a single dose of 1 mg Glucagon for Injection intramuscularly.

Table 1 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients. Table 1: Adverse Reactions Occurring in ≥ 5% of Healthy Subjects Who Received Glucagon for Injection Intramuscularly Glucagon for Injection (N=29) % of Patients Nausea 17 Vomiting 7 In a randomized, single-blind clinical study of Glucagon for Injection, 31 healthy subjects received a single dose of 1 mg Glucagon for Injection subcutaneously.

Table 2 shows the most common adverse reactions that were not present at baseline and occurred in at least 5% of patients. ( 2.1 )]. Table 2: Adverse Reactions Occurring ≥5% in Healthy Subjects Who Received Glucagon for Injection Subcutaneously Glucagon for Injection (N=31) % of Patients Injection site swelling 58 Injection site erythema 55 Vomiting 36 Nausea 32 Decreased blood pressure 23 Asthenia 23 Headache 13 Dizziness 10 Pallor 10 Diarrhea 7 Somnolence 7 Other Adverse Reactions Hypertension and tachycardia have occurred with glucagon treatment.

6.2Postmarketing Experience

Additional adverse reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. hypoglycemia and hypoglycemic coma. Patients taking indomethacin may be more likely to experience hypoglycemia following glucagon administration [see Drug Interactions ( 7 )] .

Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusion of glucagon.

Glucagon

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Glucagon

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.2Hypoglycemia in Patients with Insulinoma

5.3Hypersensitivity and Allergic Reactions

5.5Necrolytic Migratory Erythema

5.6Hyperglycemia in Patients with Diabetes

5.7Blood Pressure and Heart Rate Increase in Patients with Cardiac

5.8Hypoglycemia in Patients with Glucagonoma

Interactions

7.1Table 3: Clinically Significant Drug Interactions with Glucagon for Injection Beta-Blockers Clinical Impact:

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance