GLUCAGEN HYPOKIT

Glucagon is a 29 amino acid hormone used as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia. 5, 6, 7, 8, 10 Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose. 7, 8 Glucagon was granted FDA approval on 14 November 1960.

Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and to treat severe hypoglycemia. 5, 6, 7, 8,

Glucagon is indicated as a diagnostic aid in radiologic exams to temporarily inhibit the movement of the gastrointestinal tract and severe hypoglycemia. 1, 5, 6, 7, 8, 10 Glucagon raises blood sugar through activation of hepatic glucagon receptors, stimulating glycogenolysis and the release of glucose. 7, 8 Glucagon has a short duration of action. 5, 6, 7, 8 Glucagon may cause hyperglycemia in diabetic patients. 5, 6, 7, 8.

A 1 mg intravenous dose of glucagon reaches a C max of 7.9ng/mL with a T max of 20 minutes.

An intramuscular dose reaches a

C max of 6.9ng/mL with a T max of 13 minutes.

A 3 mg dose of glucagon nasal powder reaches a C max of 6130pg/mL with a T max of 15 minutes.

The volume of distribution of glucagon is 0.25 L/kg.

The apparent volume of distribution is 885 L.

Glucagon is a protein and so it is metabolized into smaller polypeptides and amino acids in the liver, kidney, and plasma. 5, 8.

Elimination of glucagon is not fully characterized in literature, however the kidney and liver appear to contribute significantly in animal models.

The liver and kidney are responsible for approximately 30% of glucagon elimination each.

The half life of glucagon is 26 minutes for an intramuscular dose.

The half life of glucagon nasal powder is approximately 35 minutes.

The half life of glucagon by a subcutaneous auto-injector or pre-filled syringe is 32 minutes.

A 1 mg intravenous dose of glucagon has a clearance of 13.5 mL/min/kg.

Improve decision support & research outcomes With structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates.

View sample adverse effects data in our new Data Library! See the data Improve decision support & research outcomes with our structured adverse effects data.

Patients experiencing an overdose may present with nausea, vomiting, inhibition of GI tract motility, increased blood pressure and heart rate, and decreased serum potassium. 5, 6, 7, 8 Phentolamine may be given to control blood pressure. 5, 6, 7, 8 Treatment of glucagon overdose is largely symptomatic for nausea, vomiting, and hypokalemia.

LD for intravenous glucagon in mice is 300 mg/kg and in rats is 38.6 mg/kg.

• Pheochromocytoma because of the risk of substantial increase in blood pressure.

• Insulinoma 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.

• Glucagonoma when used as a diagnostic aid because of the risk of hypoglycemia.

• Known hypersensitivity to glucagon or to any of the excipients.

• Glucagonoma when used as a diagnostic aid.

Dosage in adult and pediatric patients to treat severe hypoglycemia.

• 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.

• 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.

• 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 2.1 Important Administration Instructions for Using Glucagon for Injection to Treat Severe Hypoglycemia Glucagon for Injection is for subcutaneous, intramuscular, or intravenous injection.

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.

• 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 use.

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.

Use immediately after reconstitution.

• Immediately after reconstitution, use the same syringe to withdraw the correct dose of Glucagon for Injection.

• 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.

• If there has been no response after 15 minutes, an additional dose of Glucagon for Injection may be administered while waiting for emergency assistance.

• 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. 2.2 Dosage for Treatment of Severe Hypoglycemia 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.

Alternatively, healthcare providers may administer the dose intravenously.

• If there has been no response after 15 minutes, an additional 1 mg dose (1 mL) of Glucagon for Injection may be administered while waiting for emergency assistance.

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.

• 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 while waiting for emergency assistance. 2.3 Important Administration Instructions for Using Glucagon for Injection as a Diagnostic Aid.

• Reconstitute Glucagon for Injection with 1 mL of diluent.

• Withdraw the correct dose of Glucagon for Injection.

• Immediately after reconstitution, inject the solution intravenously or intramuscularly into upper arm, thigh, or buttocks.

• Discard 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. 2.4 Dosage in Adults for Use as a Diagnostic Aid.

• The usual dose for relaxation of the stomach, duodenum and small bowel is 0.25 mg to 0.5 mg given intravenously or 1 mg given intramuscularly, but up to 2 mg intravenously or intramuscularly may be used if required (2 mg doses produce a higher rate of nausea and vomiting than lower doses) .

• For the stomach because it is less sensitive to the effect of glucagon, 0.5 mg intravenous or 2 mg intramuscular doses are recommended.

• For the examination of the colon, it is recommended that a 2 mg dose be administered intramuscularly approximately 10 minutes prior to the procedure.

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) .

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.

Use reconstituted Glucagon for Injection, USP immediately.

Discard unused portion.

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 ) .

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.

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.

The safety and effectiveness of Glucagon for Injection for the treatment of severe hypoglycemia in pediatric patients with diabetes have been established.

Safety and effectiveness for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.

Clinical studies of glucagon did not include sufficient numbers of subjects aged and over to determine whether they respond differently from younger subjects.

Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient when used as a diagnostic aid should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.