GlucaGen

Glucagon is typically given as an injection beneath the skin, in the muscle, or in the vein. It comes as a powder and liquid, and needs to be mixed.

The dose for an adult is typically 1 milligram (mg), although lower doses may be prescribed if you have poor liver or kidney function.

All people who take glucagon should have a household member who knows how to administer the drug and recognizes the symptoms of low blood sugar.

If someone is unconscious due to a low blood-sugar episode, glucagon should be given as soon as possible.

After the injection, they should be turned onto their side to prevent choking in case they vomit.

If you give yourself glucagon, you should contact your doctor immediately afterwards.

After an injection of glucagon, you should eat a source of sugar (fruit juice, glucose gel, raisins,) and then eat a snack or small meal such as cheese and crackers or a meat sandwich (presuming you're not nauseous from the glucagon).

If you're a caregiver, get emergency medical help after administering glucagon.

People typically return to consciousness within 5 to 20 minutes of receiving glucagon.

However, if they don't wake up within 15 minutes, you might need to mix a new dose and give another injection. That's one of the reasons it is important to contact emergency medical help.

Follow the instructions on the prescription label carefully when giving this medicine. Don't use more or less of the drug than is prescribed.

Glucagon Overdose

If you suspect an overdose, you should contact a poison-control center or emergency room immediately.

You can get contact a poison-control center at (800) 222-1222.

Missed Dose of Glucagon

Glucagon is taken as needed, so you won't miss a scheduled dose.

You or a caretaker should call your doctor immediately if your symptoms don't improve after using the medicine.

Glucagen is a prescription medication used to treat insulin coma or insulin reaction from very low blood sugar (severe hypoglycemia) in adults and children with diabetes. Glucagen is a hormone, which helps raise sugar levels in the blood.

This medication comes in an injectable form and is injected in the buttock, arm, or thigh during severe hypoglycemic attacks.

Common side effects of Glucagen include nausea, vomiting, and reaction at the injection site.

Severe side effects are very rare, although nausea and vomiting may occur occasionally.

A few people may be allergic to glucagon or to one of the inactive ingredients in Glucagen, or may experience rapid heart beat for a short while.

If you experience any other reactions which are likely to have been caused by Glucagen, please contact your doctor.

Glucagon is a hormone that increases blood sugar levels. It also slows involuntary muscle movements of the stomach and intestines that aid in digestion.

Glucagon is used to treat hypoglycemia (low blood sugar). Glucagon is also used during a radiologic (x-ray) examination to help diagnose certain disorders of the stomach or intestines.

Glucagon may also be used for purposes not listed in this medication guide.

Antihypoglycemic agent; biosynthetic (recombinant DNA-derived) form of human glucagon hormone prepared using special laboratory strains of nonpathogenic Escherichia coli or Saccharomyces cerevisiae.1 2 a b c

Specific Drugs

Storage

Parenteral

Glucagon (rDNA origin, Lilly): 20–25°C.1 b Use reconstituted solution immediately; discard any unused portion.a b

Glucagon hydrochloride (rDNA origin, GlucaGen): 20–25°C for up to 24 months.c Do not freeze; protect from light.c Use reconstituted solution immediately; discard any unused portion.a c

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness

• Difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• hives, itching, or skin rash
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• slow or fast heartbeat
• sweating
• tightness in the chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For GlucaGen HypoKit:

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.

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.

GlucaGen (glucagon [rDNA origin] for injection) is an antihypoglycemic agent and a gastrointestinal motility inhibitor. It is produced by expression of recombinant DNA in a Saccharomyces cerevisiae vector with subsequent purification. The chemical structure of the glucagon in GlucaGen is identical to human glucagon and to glucagon extracted from beef and pork pancreas. Glucagon with the empirical formula of C153H225N43O49S, and a molecular weight of 3483, is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is:

GlucaGen is a sterile, lyophilized white powder in a 2 mL vial (appearance of the powder may vary, and occasionally the powder may appear compacted). The reconstituted solution contains glucagon as hydrochloride 1 mg/mL (1 unit/mL) and lactose monohydrate (107 mg). GlucaGen is supplied at pH 2.5-3.5 and is soluble in water.