Data from FDA - Curated by EPG Health - Last updated 30 April 2018

Indication(s)

1 INDICATIONS AND USAGE GlucaGen is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated for: •Treatment of severe hypoglycemia (1.1) •Use as a diagnostic aid (1.2) 1.1 Treatment of severe hypoglycemia GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes mellitus treated with insulin. Because GlucaGen depletes glycogen stores, the patient should be given supplemental carbohydrates as soon as he/she awakens and is able to swallow, especially children or adolescents. Medical evaluation is recommended for all patients who experience severe hypoglycemia. 1.2 Use as a diagnostic aid GlucaGen is indicated for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. GlucaGen is not recommended in combination with anticholinergic agents due to the possibility of increased side effects. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied.

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Advisory information

contraindications
4 CONTRAINDICATIONS GlucaGen is contraindicated in patients with: •Known hypersensitivity to glucagon, lactose or any other constituent in GlucaGen •Pheochromocytoma [see Warnings and Precautions (5.1)] •Insulinoma [see Warnings and Precautions (5.2)] •Do not use in patients with known hypersensitivity to glucagon or lactose (4) •Do not use in patients with pheochromocytoma (4) •Do not use in patients with insulinoma (4)
Adverse reactions
6 ADVERSE REACTIONS Side effects may include nausea and vomiting at doses above 1 mg or with rapid injection. Hypotension has been reported up to 2 hours after administration in patients receiving GlucaGen as premedication for upper GI endoscopy procedures. GlucaGen exerts positive inotropic and chronotropic effects and may, therefore, cause tachycardia and hypertension. Adverse reactions indicating toxicity of GlucaGen have not been reported. A temporary increase in both blood pressure and pulse rate may occur following the administration of GlucaGen. Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of GlucaGen’s short half-life [see Drug Interactions (7.1)] . The increase in blood pressure and pulse rate may require therapy in patients with pheochromocytoma or coronary artery disease [see Warnings and Precautions (5.1)]. Anaphylactic reactions may occur in some cases [see Warnings and Precautions (5.3)] . The following adverse reactions have been identified during postapproval use of GlucaGen. 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. Table 1 Frequency of Adverse Reactions Treatment of severe hypoglycemia Frequency (%) Adverse Reaction < 10 Nausea < 1 Vomiting Use as a diagnostic aid < 10 Nausea < 1 Vomiting < 1 Hypoglycemia <1 Hypoglycemic coma Adverse reactions seen with GlucaGen are: •Nausea and vomiting (6) •Temporary increase in blood pressure and pulse may occur after administration. (6) 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 .

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION For GlucaGen HypoKit: Treatment of severe hypoglycemia (GlucaGen HypoKit) •Reconstitute before administration. (2.1) •Inject 1 mL (adults and children, weighing more than 55 lbs (25 kg)) or 0.5 mL (children weighing less than 55 lbs (25 kg)) subcutaneously, intramuscularly, or intravenously. (2.1) •If the weight is not known: Children younger than 6 years should be given 0.5 mL and children 6 years and older should be given 1 mL. (2.1) •Seek emergency assistance immediately after subcutaneous or intramuscular injection of glucagon. Glucagon injection may be repeated while waiting for emergency assistance. (2.1) •Intravenous glucose MUST be administered if the patient fails to respond to glucagon. (2.1) •When the patient responds to treatment, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia. (2.1) Use as a diagnostic aid (GlucaGen Diagnostic Kit and GlucaGen 10-Pack) •Reconstitute before administration. (2.2) •The dose ranges from 0.2 mg to 2 mg depending on the diagnostic technique and the route of administration. (2.2) •After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied. (2.2) 2.1 Treatment of severe hypoglycemia 1. Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing GlucaGen powder and inject all the liquid from the syringe into the vial. 2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency. 3. The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon. 4. The reconstituted GlucaGen should be used immediately after reconstitution. 5. Inject 1 mL (adults and children, weighing more than 55 lbs (25 kg)) or 0.5 mL (children weighing less than 55 lbs (25 kg)) subcutaneously, intramuscularly, or intravenously. Common injection sites for GlucaGen are upper arms, thighs, or buttocks. If the weight is not known: children younger than 6 years should be given a 0.5 mL and children 6 years and older should be given 1 mL. 6. Discard any unused portion. 7. Emergency assistance should be sought immediately after subcutaneous or intramuscular injection of glucagon. 8. The glucagon injection may be repeated using a new kit while waiting for emergency assistance. 9. Intravenous glucose MUST be administered if the patient fails to respond to glucagon. 10. When the patient has responded to the treatment, give fast-acting and long-acting oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia. For GlucaGen Diagnostic Kit and the GlucaGen 10-pack: 2.2 Use as a diagnostic aid 1.GlucaGen should be reconstituted with 1 mL of Sterile Water for Reconstitution (if supplied) or 1 mL of Sterile Water for Injection, USP. Using a syringe, withdraw all of the Sterile Water for Reconstitution (if supplied) or 1 mL Sterile Water for Injection, USP and inject into the GlucaGen vial. 2.Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency. 3.The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon. 4.The reconstituted GlucaGen should be used immediately after reconstitution. 5.GlucaGen must be administered by medical personnel. 6. Discard any unused portion. 7.Onset of action after an injection will depend on the organ under examination and route of administration [see Pharmacodynamics (12.2)] . 8.The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5 mg to 0.75 mg intravenously and 1 mg to 2 mg intramuscularly [see Pharmacodynamics (12.2)] . 9.After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied. The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are intended only for use by healthcare providers as a diagnostic aid. The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are not intended for use by patients to treat severe hypoglycemia because they are not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.
Use in special populations
8 USE IN SPECIFIC POPULATIONS •Nursing mothers: unknown whether drug is excreted in human milk, therefore caution should be exercised. (8.3) •Pediatrics: reported safe and effective for treatment of severe hypoglycemia. Safety and effectiveness for use as a diagnostic aid have not been established. (8.4) 8.1 Pregnancy Reproduction studies were performed in rats and rabbits at GlucaGen doses of 0.4, 2.0, and 10 mg/kg. These doses represent exposures of up to 100 and 200 times the human dose based on mg/m2 for rats and rabbits, respectively, and revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Glucagon does not cross the human placenta barrier. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GlucaGen is administered to a nursing woman. No clinical studies have been performed in nursing mothers, however, GlucaGen is a peptide and intact glucagon is not absorbed from the GI tract. Therefore, even if the infant ingested glucagon it would be unlikely to have any effect on the infant. Additionally, GlucaGen has a short plasma half-life thus limiting amounts available to the child. 8.4 Pediatric Use For the treatment of severe hypoglycemia: The use of glucagon in pediatric patients has been reported to be safe and effective. For use as a diagnostic aid: Safety and effectiveness in pediatric patients have not been established.
Pregnancy and lactation
8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GlucaGen is administered to a nursing woman. No clinical studies have been performed in nursing mothers, however, GlucaGen is a peptide and intact glucagon is not absorbed from the GI tract. Therefore, even if the infant ingested glucagon it would be unlikely to have any effect on the infant. Additionally, GlucaGen has a short plasma half-life thus limiting amounts available to the child.

Interactions

7 DRUG INTERACTIONS •Beta-blockers may cause a greater increase in both pulse and blood pressure after administration. (7.1) •Glucagon may lose its ability to raise blood glucose or may produce hypoglycemia when given with indomethacin. (7.2) •Coadministration with an anticholinergic drug is not recommended due to increased gastrointestinal side effects. (7.3) •Glucagon may increase the anticoagulant effect of warfarin. (7.4) •Insulin reacts antagonistically towards glucagon. (7.5) 7.1 Beta-blockers Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of glucagon’s short half-life. The increase in blood pressure and pulse rate may require therapy in patients with pheochromocytoma or coronary artery disease. 7.2 Indomethacin When used with indomethacin, glucagon may lose its ability to raise blood glucose or may even produce hypoglycemia. Therefore, caution should be exercised for patients taking indomethacin when glucagon will be administered. 7.3 Anticholinergic Drugs Coadministration with an anticholinergic drug is not recommended due to increased gastrointestinal side effects. 7.4 Warfarin Glucagon may increase the anticoagulant effect of warfarin. Therefore, caution should be exercised for patients taking warfarin when glucagon will be administered. 7.5 Insulin Insulin reacts antagonistically towards glucagon. Therefore, caution should be exercised when glucagon is used as a diagnostic aid in diabetes patients.

More information

Category Value
Authorisation number NDA020918
Agency product number 1H87NVF4DB
Orphan designation No
Product NDC 0597-0053,0597-0260
Date Last Revised 18-04-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Boehringer Ingelheim Pharmaceuticals, Inc.