GlucaGen HypoKit (Page 2 of 5)

5 WARNINGS AND PRECAUTIONS

5.1 Substantial Increase in Blood Pressure in Patients with Pheochromocytoma

GlucaGen is contraindicated in patients with pheochromocytoma because GlucaGen 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 for the short time that control would be needed.

5.2 Hypoglycemia in Patients with Insulinoma

In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, GlucaGen administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GlucaGen is contraindicated in patients with insulinoma [see Contraindications (4)]. If a patient develops symptoms of hypoglycemia after a dose of GlucaGen, give glucose orally or intravenously.

5.3 Hypersensitivity and Allergic Reactions

Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. GlucaGen is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications (4)].

5.4 Lack of Efficacy in Patients with Decreased Hepatic Glycogen

GlucaGen 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 GlucaGen administration to be effective. Patients with these conditions should be treated with glucose.

5.5 Necrolytic Migratory Erythema

Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. NME lesions may affect the face, groin, perineum and legs or be more widespread. In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.

5.6 Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid

Treatment with GlucaGen in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment and treat if indicated.

5.7 Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when used as a Diagnostic Aid

GlucaGen may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of GlucaGen as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy.

5.8 Hypoglycemia in Patients with Glucagonoma

Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to use as a diagnostic aid as GlucaGen is contraindicated in this setting [see Contraindications (4)].

6 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)]

The following 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.

Injection site reactions
Nausea
Vomiting
Headache
Dizziness
Asthenia
Pallor
Diarrhea
Somnolence
Generalized allergic reactions including anaphylactic shock with breathing difficulties and hypotension
Hypertension and tachycardia
Decreased blood pressure. Hypotension has been reported up to 2 hours after administration in patients receiving GlucaGen as premedication for upper gastrointestinal endoscopy procedures.
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 post marketing in patients receiving continuous infusion of glucagon.

7 DRUG INTERACTIONS

Table 1: Clinically Significant Drug Interactions with GlucaGen

Beta-Blockers

Clinical Impact:

Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GlucaGen.

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, GlucaGen may lose its ability to raise blood glucose or may even produce hypoglycemia.

Intervention:

Monitor blood glucose levels during GlucaGen treatment of patients taking indomethacin.

Anticholinergic Drugs

Clinical Impact:

The concomitant use of anticholinergic drugs and GlucaGen increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility.

Intervention:

Concomintant use of anticholinergic drugs with GlucaGen for use as a diagnostic aid is not recommended.

Warfarin

Clinical Impact:

GlucaGen 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 GlucaGen is used as a diagnostic aid in patients receiving insulin.

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