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Glucagon

FDA Drug Information • Also known as: Baqsimi, Glucagon, Glucagon 1555

Brand Names
Baqsimi, Glucagon, Glucagon 1555
Dosage Form
KIT
Product Type
HUMAN PRESCRIPTION DRUG

Description

11 DESCRIPTION Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. Glucagon is produced by solid state peptide synthesis. The chemical structure of the glucagon is identical to human glucagon. Glucagon is a single-chain polypeptide that contains 29 amino acid residues and has a molecular weight of 3482.8 Daltons. The empirical formula is C 153 H 225 N 43 O 49 S. The primary sequence of glucagon is shown below. Glucagon (synthetic origin) is a white to off-white powder. It is relatively insoluble in water but is soluble at a pH of less than 3 or more than 9.5. Glucagon for injection, USP is a sterile, white to off white lyophilized powder or plug in a vial and a syringe of sterile diluent for intravenous, intramuscular, or subcutaneous use. The vial contains 1 mg of glucagon USP, 49 mg of lactose monohydrate. Hydrochloric acid may have been added during manufacture to adjust the pH of the glucagon to 2.5 to 3.0. One International Unit of glucagon is equivalent to 1 mg of glucagon. The 1 mL diluent syringe contains 12 mg of glycerin, 1 mg hydrochloric acid, and Water for Injection, at pH 1.8 to 2.2. Glucagon Primary Sequence

What Is Glucagon Used For?

1 INDICATIONS AND USAGE 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 mellitus. 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.

    • Dosage and Administration

    2 DOSAGE AND ADMINISTRATION Dosage in adult and pediatric patients to treat severe hypoglycemia ( 2.2 )

  • Adults and Pediatric Patients Weighing 20 kg or More: ▪ 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) may be administered while waiting for emergency assistance.
  • Pediatric Patients Weighing Less Than 20 kg: ▪ The recommended dosage is 0.5 mg (0.5 mL) or dose equivalent to 20 mcg/kg to 30 mcg/kg 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) may be administered while waiting for emergency assistance. Important Administration Instructions for Using Glucagon for Injection to Treat Severe Hypoglycemia ( 2.1 )
  • Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.
  • See the Full Prescribing Information for administration instructions Dosage in Adults for Using Glucagon for Injection as a Diagnostic Aid ( 2.4 )
  • Doses required for relaxation of the stomach, duodenum, and small bowel, depend on the onset and duration of effect required for the examination.
  • The dose for relaxation of the duodenum and small bowel is 0.25 mg to 0.5 mg given intravenously or 1 mg given intramuscularly.
  • For the stomach 0.5 mg intravenous or 2 mg intramuscular doses are recommended.
  • For the colon, it is recommended that a 2 mg dose be administered intramuscularly approximately 10 minutes prior to the procedure.
  • See the Full Prescribing Information for administration instructions ( 2.3 ) 2.1 Important Administration Instructions for Using Glucagon for Injection to Treat Severe Hypoglycemia Glucagon 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.
  • Swirl the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted solution should be clear and of a water-like consistency at time of...

    • Side Effects (Adverse Reactions)

    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 including erythema and swelling
  • 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 glucagon 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. Glucagon adverse reactions include: injection site reactions, nausea, vomiting, headache, dizziness, asthenia, pallor, diarrhea, somnolence, and decreased blood pressure. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    • Drug Interactions

    7 DRUG INTERACTIONS Table 1: 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 increase 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.

  • Beta-blockers : Patients taking beta-blockers may have a transient increase in pulse and blood pressure. ( 7 )
  • Indomethacin : In patients taking indomethacin Glucagon for Injection may lose its ability to raise glucose or may produce hypoglycemia. ( 7 )
  • Anticholinergic drugs : Concomitant use of anticholinergic drugs with Glucagon for Injection for use as a diagnostic aid is not recommended. ( 7 )
  • Warfarin : Glucagon for Injection may increase the anticoagulant effect of warfarin. ( 7 )
  • Insulin : Monitor blood glucose when Glucagon for Injection is used as a diagnostic aid in patients receiving insulin. ( 7 )

    • Contraindications

    4 CONTRAINDICATIONS Glucagon for Injection is contraindicated in patients with:

  • Pheochromocytoma because of the risk of substantial increase in blood pressure [see Warning and Precautions (5.1) ]
  • Insulinoma because of the risk of hypoglycemia [see Warning and Precautions (5.2) ]
  • 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 Warning and Precautions (5.3) ]
  • Glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia [see Warnings and Precautions (5.8) ]
  • Pheochromocytoma ( 4 )
  • Insulinoma ( 4 )
  • Known hypersensitivity to glucagon or to any of the excipients ( 4 )
  • Glucagonoma when used as a diagnostic aid ( 4 )

    • Pregnancy and Breastfeeding

    8.1 Pregnancy Risk Summary 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 a rat reproduction study, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 40 times the human dose, based on body surface area (mg/m 2 ) (see Data ). 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% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats given animal sourced glucagon twice-daily by injection at doses up to 2 mg/kg (up to 40 times the human dose based on body surface area extrapolation, mg/m 2 ) during the period of organogenesis, there was no evidence of increased malformations or embryofetal lethality.

    Overdosage

    10 OVERDOSAGE If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, the serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

    How Supplied

    16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Glucagon Emergency Kit for Low Blood Sugar contains 1 mg Glucagon for Injection, USP (a sterile, lyophilized white to off-white powder or plug) in a single-dose vial and 1 prefilled syringe containing 1 mL of diluent of Glucagon.

  • 1 mg per vial - with 1 mL of diluting solution (PFS) (1s) NDC of Pre-filled Syringe: 0378-8066-32; NDC of Vial Label: 0378-8065-32; NDC of Carton: 0378-8067-90. 16.2 Storage and Handling Before Reconstitution: Store Glucagon for Injection, USP at controlled room temperature 20° to 25°C (68° to 77°F) [See USP]. Do not use Glucagon for Injection, USP if the expiration date has passed. Do not freeze. Keep in its original package and away from light. After Reconstitution: Use reconstituted Glucagon for Injection, USP immediately. Discard unused portion [see Dosage and Administration (2.3) ].

    • About This Information

    This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.

    What are side effects?

    Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.

    What are drug interactions?

    Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.