Glucagon
Glucagon Prescribing Information
Indications and Usage (1 INDICATIONS AND USAGEGlucagon for Injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated:
1.1 Severe HypoglycemiaGlucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes. 1.2 Diagnostic AidGlucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. | 09/2019 |
Dosage and Administration (2 DOSAGE AND ADMINISTRATIONDosage in adults and pediatric patients using the glucagon emergency kit for low blood sugar to treat severe hypoglycemia
Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe Hypoglycemia
Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid
2.1 Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe HypoglycemiaGlucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision. Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about Glucagon for Injection and its Instructions for Use. Administer Glucagon for Injection as soon as possible when severe hypoglycemia is recognized. Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for Glucagon for Injection. Emphasize the following instructions to the patient or caregiver:
2.2 Dosage in Adults and Pediatric Patients for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe HypoglycemiaAdults and Pediatric Patients Weighing More Than 25 kg or for Pediatric Patients with Unknown Weight 6 Years and Older
Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age
2.3 Important Administration Instruction for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid
2.4 Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid
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Contraindications (4 CONTRAINDICATIONSGlucagon for Injection is contraindicated in patients with:
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Warnings and Precautions (5 WARNINGS AND PRECAUTIONS
5.1 Catecholamine Release in Patients with PheochromocytomaGlucagon for Injection is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor [see Contraindications ]. If the patient develops a dramatic 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 InsulinomaIn patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, Glucagon for Injection administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. Glucagon for Injection is contraindicated in patients with insulinoma [see Contraindications ]. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.5.3 Hypersensitivity and Allergic ReactionsAllergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Glucagon for Injection is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications ]. 5.4 Lack of Efficacy in Patients with Decreased Hepatic GlycogenGlucagon for Injection 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 Glucagon for Injection administration to be effective. Patients with these conditions should be treated with glucose. 5.5 Necrolytic Migratory ErythemaNecrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagonproducing 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 AidTreatment with Glucagon for Injection 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 AidGlucagon for Injection 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 Glucagon for Injection as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. 5.8 Hypoglycemia in Patients with GlucagonomaGlucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Glucagon for Injection is contraindicated in patients with glucagonoma when used as a diagnostic aid [see Contraindications ]. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously. | 09/2019 |
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 Severe HypoglycemiaGlucagon for Injection is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes.
- as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients ()
1.2 Diagnostic AidGlucagon for Injection is indicated as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients.
2.2 Dosage in Adults and Pediatric Patients for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe Hypoglycemia- The recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.
- If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance.
- The recommended dosage is 0.5 mg (0.5 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.
- If there has been no response after 15 minutes, an additional 0.5 mg dose (0.5 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance.
- Adults and Pediatric Patients Weighing More Than 25 kg or for Pediatric Patients with Unknown Weight 6 Years and Older:
- The recommended dosage is 1 mg (1 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.- If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance.
- Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age:
- The recommended dosage is 0.5 mg (0.5 mL) injected subcutaneously or intramuscularly into the upper arm, thigh, or buttocks, or intravenously.- If there has been no response after 15 minutes, an additional 0.5 mg dose (0.5 mL) of Glucagon for Injection may be administered using a new kit while waiting for emergency assistance.
2.1 Important Administration Instructions for Using the Glucagon Emergency Kit for Low Blood Sugar to Treat Severe HypoglycemiaGlucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.
Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about Glucagon for Injection and its Instructions for Use. Administer Glucagon for Injection as soon as possible when severe hypoglycemia is recognized.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for Glucagon for Injection. Emphasize the following instructions to the patient or caregiver:
- Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing Glucagon for Injection powder and inject all the liquid from the syringe into the vial.
- Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted solution should be clear and colorless. Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use.
- The reconstituted solution is 1 mg per mL glucagon.
- Immediately after reconstitution, inject the solution subcutaneously or intramuscularly in the upper arm, thigh, or buttocks. In addition, healthcare providers may administer intravenously.
- Call for emergency assistance immediately after administering the dose.
- When the patient has responded to the treatment and is able to swallow, give oral carbohydrates to restore the liver glycogen and prevent recurrence of hypoglycemia.
- Discard any unused portion.
- Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.
- See the Full Prescribing Information for administration instructions
2.4 Dosage in Adults for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid- The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg administered intravenously or 1 mg administered intramuscularly; the recommended dose to relax the colon is 0.5 mg to 0.75 mg administered intravenously or 1 mg to 2 mg administered intramuscularly[see Clinical Pharmacology ].
- The onset of action after an injection will depend on the organ under examination and route of administration[see Clinical Pharmacology ].
- The recommended diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg administered intravenously or 1 mg administered intramuscularly; the recommended dose to relax the colon is 0.5 mg to 0.75 mg administered intravenously or 1 mg to 2 mg administered intramuscularly.
- See the Full Prescribing Information for administration instructions ()
2.3 Important Administration Instruction for Using Glucagon for Injection Diagnostic Kit and Glucagon for Injection Single-Dose Vial as a Diagnostic Aid- Reconstitute Glucagon for Injection with 1 mL of Sterile Water for Injection. Using a syringe, withdraw all of the Sterile Water for Injection (if supplied) or 1 mL Sterile Water for Injection and inject into the Glucagon for Injection vial.
- Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and colorless. Inspect visually for particulate matter and discoloration. If the resulting solution is cloudy or contains particulate matter do not use.
- The reconstituted solution is 1 mg per mL glucagon.
- Immediately after reconstitution, inject the solution intravenously or intramuscularly into upper arm, thigh, or buttocks.
- Discard any unused portion.
- After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure.
Glucagon for Injection is a white lyophilized powder supplied as follows:
- 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose syringe of Sterile Water for Injection, USP (Glucagon Emergency Kit for Low Blood Sugar)
- 1 mg single-dose vial of Glucagon for Injection
- 1 mg single-dose vial of Glucagon for Injection with a 1 mL single-dose vial of Sterile Water for Injection, USP (Diagnostic Kit)
Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In rat and rabbit reproduction studies, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 100 and 200 times the human dose, respectively, based on body surface area (mg/m2)
In rats and rabbits given glucagon by injection at doses of 0.4, 2.0, and 10 mg/kg (up to 100 and 200 times the human dose based on mg/m2for rats and rabbits, respectively) there was no evidence of increased malformations or embryofetal lethality.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Glucagon for Injection is contraindicated in patients with:
- Pheochromocytoma [see Warnings and Precautions ()]
5.1 Catecholamine Release in Patients with PheochromocytomaGlucagon for Injection is contraindicated in patients with pheochromocytoma because glucagon may stimulate the release of catecholamines from the tumor
[see Contraindications ].If the patient develops a dramatic 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. - Insulinoma [see Warnings and Precautions (because of the risk of hypoglycemia)]
5.2 Hypoglycemia in Patients with InsulinomaIn patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, Glucagon for Injection administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. Glucagon for Injection is contraindicated in patients with insulinoma
[see Contraindications ].If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously. - 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 Hypersensitivity and Allergic ReactionsAllergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. Glucagon for Injection is contraindicated in patients with a prior hypersensitivity reaction
[see Contraindications ]. - Glucagonoma [see Warnings and Precautions (because of risk of hypoglycemia when used as a diagnostic aid)]
5.8 Hypoglycemia in Patients with GlucagonomaGlucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Glucagon for Injection is contraindicated in patients with glucagonoma when used as a diagnostic aid
[see Contraindications ].Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment, and monitor for changes in blood glucose levels during treatment. If a patient develops symptoms of hypoglycemia after a dose of Glucagon for Injection, give glucose orally or intravenously.