glucagon recombinant (GlucaGen)

Glucagon is a hormone produced by the pancreas that, along with insulin, controls the level of glucose in the blood. Glucagon has the opposite effect of insulin. It increases the glucose levels in blood. Glucagon, the drug, is a synthetic (man-made) version of human glucagon and is manufactured by genetic engineering using the bacteria Escherichia coli.

Is glucagon available as a generic drug?

yes

Do I need a prescription for glucagon?

yes

Glucagon is used to treat severe hypoglycemia in diabetic patients. It is also used for radiologic examination of the stomach, duodenum, small bowel, and colon.

Nausea and vomiting may occur occasionally after injection of glucagon, but this may be a symptom of the hypoglycemia for which glucagon is being given. Rare allergic-type reactions may occur with glucagon including itching, respiratory distress, or low blood pressure.

Glucagon should not be administered to hypoglycemic patients who are also experiencing starvation, adrenal insufficiency or are suffering from chronic hypoglycemia. These medical conditions may be associated with an inability of the liver to produce glucose sufficiently in response to glucagon. For these patients, oral glucose is more effective if the patient is conscious. If the patient is not conscious, intravenous glucose should be given.

For hypoglycemia, adults and children weighing 44 pounds or more should receive 1 mg (1 unit) of glucagon from the glucagon emergency kit either intravenously, subcutaneously or intramuscularly. Children weighing less than 44 pounds should receive 0.5 mg (0.5 units) of glucagon or an amount equal to 20-30 micrograms per kilogram or 0.009-0.014 milligrams per pound.

When using GlucaGen® the dose for adults and children weighing more than 25 kg (55 pounds) is 1 mg given intravenously, subcutaneously or intramuscularly. Children weighing less than 25 kg should receive 0.5 ml. If weight is unknown children 6 years of age and older should receive 1 ml and children younger than 6 years of age should receive 0.5 ml.

Before injecting, the mixture should appear clear and free of any floating particles. It should not be used if it is discolored. Once glucagon is administered, blood glucose measurements should be obtained until the patient is no longer experiencing hypoglycemic symptoms. Intravenous or oral glucose should be given to help restore glucose levels in the body and prevent further hypoglycemia. A physician should be notified immediately after a hypoglycemic episode to consider a change in the dose of drug being used to treat the diabetes in order to prevent further episodes of hypoglycemia.

Glucagon may increase the anticoagulant effect of warfarin (Coumadin) and other anticoagulants causing an increase in the slow clotting of blood and a greater risk of developing an episode of bleeding. Careful monitoring is necessary when glucagon is given to people wore also being treated with anticoagulants.

Insulin reverses the effect of glucagon.

Glucagon should not be given with anticholinergic drugs due to increased risk of stomach and intestine-related side effects.

Indomethacin (Indocin, Indocin-SR) reduces the effect of glucagon.

There are no studies of the safety of glucagon in pregnant women. Glucagon does not cross the placenta and the risk to the fetus is considered to be low.

It is not known if glucagon is secreted in breast milk.

What preparations of glucagon are available?

Glucagon is available as an emergency kit.

• The kit contains freeze-dried glucagon as a powder for injection 1 ml syringe of diluent.
• The powder contains 1 mg (1 unit) of glucagon and 49 mg of lactose.
• The diluent contains 12 mg/ml of glycerine, water for Injection, and hydrochloric acid. The diluent is mixed with the glucagon powder prior to injection.
• GlucaGen Hypokit® and GlucaGen Diagnostic Kit® have 1 vial containing 1 mg (1 unit) of glucagon powder and a disposable syringe containing 1 ml sterile water for reconstitution (mixing). Glucagon is also available in a 10-pack containing ten 1 mg vials of glucagon.

How should I keep glucagon stored?

The glucagon emergency kit and GlucaGen® should be stored at room temperature, 20 C to 25 C (68 F to 77 F) prior to mixing with diluent (glycerin or sterile water). Once mixed with diluent, the prepared drug should be used immediately.

How does glucagon work?

Glucagon is used to increase the blood glucose level in severe hypoglycemia (low blood glucose). Glucagon is a glucose-elevating drug. Other glucose-elevating drugs are glucose itself and diazoxide (Proglycem). In diabetic patients, low blood glucose (hypoglycemia) may occur from an unintended excess of injected insulin or oral glucose-lowering medication, such as a sulfonylurea like glipizide (Glucotrol), that are being used to treat diabetes. Hypoglycemia also may occur as a result of insufficient caloric intake or sudden, excessive physical exertion. Symptoms of hypoglycemia include:

• nervousness,
• cool skin,
• headache,
• confusion,
• convulsions or
• coma.

In any hypoglycemic situation, efforts should be made to raise the glucose level in the blood. Glucagon raises blood glucose levels by preventing the liver from storing glucose, increasing glucose formation in the liver from dietary proteins and fats, and increasing the release of glucose from the liver into blood. Glucagon transiently paralyzes the muscles of the intestines and occasionally is used during testing that requires the intestines to be flaccid, for example, endoscopic retrograde cholangiopancreatography and barium enema.

When was glucagon approved by the FDA?

The FDA approved glucagon in November 1960.