Glucagen (Injection)

Glucagon injection is an emergency medicine for treating severe hypoglycemia (low blood sugar) in diabetes patients who are treated with insulin and have lost consciousness or cannot take any form of sugar by mouth.

Glucagon injection is also used as a diagnostic aid during X-ray tests of the stomach and intestines. It helps improve test results by relaxing the muscles of the stomach and intestines.

This medicine is available only with your doctor's prescription.

Patients with diabetes should know the signs of hypoglycemia (low blood sugar). These signs can appear quickly and may be caused by:

• using too much insulin (“insulin reaction”) or as a side effect of oral antidiabetic medicines
• delaying or missing a scheduled snack or meal
• being sick (especially with vomiting or diarrhea)
• exercising more than usual.

If not treated, hypoglycemia can lead to unconsciousness, seizures, and possibly death. Early signs of hypoglycemia include: feeling anxious, changes in behavior similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, trouble concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.

Signs of hypoglycemia can vary from person to person. It's important to recognize your own signs of low blood sugar so you can treat it quickly. It is also a good idea to check your blood sugar to confirm that it is low.

You should know what to do if you have signs of low blood sugar. Eating or drinking something with sugar when you first notice these signs will usually prevent them from worsening and might make the use of glucagon unnecessary. Good sources of sugar include glucose tablets or gel, corn syrup, honey, sugar cubes or table sugar (dissolved in water), fruit juice, or non-diet soft drinks. If a meal is not scheduled soon (1 hour or less), you should also eat a light snack, such as crackers and cheese or half a sandwich, or drink a glass of milk to help keep your blood sugar from dropping again. You should not eat hard candy or mints because the sugar will not enter your bloodstream quickly enough. You also should not eat high-fat foods like chocolate because the fat slows the sugar's entry into the bloodstream. After 10 to 20 minutes, check your blood sugar again to ensure it is not still too low.

If symptoms do not improve after eating or drinking something sweet, tell someone to take you to your doctor or to a hospital right away. Do not try to drive, use machines, or do anything dangerous until you have eaten something sweet.

Tell your doctor right away if you experience blurred vision, dizziness, nervousness, headache, a pounding sensation in the ears, or a slow or fast heartbeat. These may indicate high blood pressure.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you notice a rash, itching, trouble breathing, trouble swallowing, swelling of your hands, face, or mouth, or feel lightheaded, dizzy, or faint while receiving this medicine.

This medicine may cause serious skin reactions, including necrolytic migratory erythema (NME). Contact your doctor immediately if you experience blistering, peeling, or a red skin rash on your face, groin, buttocks, or legs.

If severe symptoms occur, such as seizures or unconsciousness, the patient with diabetes should not be given anything to eat or drink. There is a risk of choking if they cannot swallow properly. Glucagon should be administered, and the patient's doctor should be contacted immediately.

If glucagon needs to be injected, a family member or friend should know the following:

• After the injection, turn the patient onto their left side. Glucagon may cause some patients to vomit, and this position will help reduce the risk of choking.
• The patient should regain consciousness within 15 minutes after glucagon is injected; if not, a second dose may be given. Take the patient to a doctor or hospital emergency care as soon as possible, as being unconscious for too long can be harmful.
• Once the patient is conscious and able to swallow, offer them some form of sugar. Glucagon is effective for only about 1½ hours and is used until the patient can swallow. Quick sources of sugar include fruit juice, corn syrup, honey, and sugar cubes or table sugar (dissolved in water). If a snack or meal is not scheduled for an hour or more, the patient should also eat some crackers and cheese or half a sandwich, or drink a glass of milk to prevent hypoglycemia from happening again before the next meal or snack.
• The patient or caregiver should keep checking the patient's blood sugar. For about 3 to 4 hours after the patient regains consciousness, check the blood sugar every hour.
• If nausea and vomiting prevent the patient from swallowing some form of sugar for an hour after glucagon is given, seek medical help.

Keep your doctor informed about any hypoglycemic episodes or use of glucagon, even if symptoms are managed and there seem to be no ongoing issues. Complete information is essential for the doctor to provide the best care.

Replace your supply of glucagon as soon as possible, in case another hypoglycemic episode happens.

You should wear a medical identification (ID) bracelet or chain at all times. Additionally, you should carry an ID card that lists your medical condition and medications.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not shown any specific problems related to using GlucaGen® for treating severe hypoglycemia in children. However, the safety and effectiveness of glucagon injection have not been proven for use as a diagnostic aid.

Studies have not shown any specific problems related to using Gvoke® for treating severe hypoglycemia in children aged 2 years and older. However, safety and effectiveness have not been established in children younger than 2 years.

Geriatric

There have been no studies on how age affects the use of Gvoke® in older adults. However, no specific problems have been documented so far.

No information is available on how age affects the use of GlucaGen® in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be combined even if an interaction is possible. In these cases, your doctor might adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Aclidinium
• Amantadine
• Amitriptyline
• Amoxapine
• Atropine
• Belladonna
• Benztropine
• Biperiden
• Brompheniramine
• Carbinoxamine
• Carisoprodol
• Chlorpheniramine
• Chlorpromazine
• Clemastine
• Clidinium
• Clomipramine
• Clozapine
• Cyclobenzaprine
• Cyclopentolate
• Cyproheptadine
• Darifenacin
• Desipramine
• Dicyclomine
• Dimenhydrinate
• Diphenhydramine
• Doxepin
• Fesoterodine
• Flavoxate
• Fluphenazine
• Glycopyrrolate
• Glycopyrronium Tosylate
• Homatropine
• Hydroxyzine
• Hyoscyamine
• Imipramine
• Indomethacin
• Ipratropium
• Loxapine
• Meclizine
• Mepenzolate
• Nortriptyline
• Olanzapine
• Orphenadrine
• Oxitropium Bromide
• Oxybutynin
• Paroxetine
• Perphenazine
• Pimozide
• Pipenzolate Bromide
• Pirenzepine
• Prochlorperazine
• Procyclidine
• Promethazine
• Propantheline
• Propiverine
• Protriptyline
• Quetiapine
• Revefenacin
• Scopolamine
• Solifenacin
• Stramonium
• Terodiline
• Thioridazine
• Thiothixene
• Tiotropium
• Tizanidine
• Tolterodine
• Trifluoperazine
• Trihexyphenidyl
• Trimipramine
• Tropicamide
• Trospium
• Umeclidinium
• Valethamate
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical conditions, especially:

• Adrenal insufficiency or
• Chronic hypoglycemia or
• Prolonged fasting or starvation—These conditions should be treated with glucose.

• Allergy to glucose or
• Allergy to lactose or
• Glucagonoma (a rare type of pancreas tumor) or
• Insulinoma (pancreas tumor) or
• Pheochromocytoma (adrenal gland tumor)—This medicine should not be used in patients with these conditions.

• Coronary artery disease or
• Diabetes mellitus or
• Heart disease—Use with caution as it may make these conditions worse.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Rare

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dizziness
• dry mouth
• fast heartbeat
• flushed, dry skin
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• sweating
• trouble breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting

Incidence not known

• Chest tightness
• cough
• diarrhea
• 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
• lack or loss of strength
• paleness of the skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sleepiness or unusual drowsiness
• slow or fast heartbeat

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. Your health care professional may also 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, are bothersome, or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.

In the U.S.

• Glucagen
• Glucagen Diagnostic Kit
• Glucagon
• Glucagon Diagnostic Kit
• Glucagon Emergency Kit

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Glucose Regulation, Antihypoglycemic

Glucagon injection is an emergency medicine and must be used only as directed by your doctor. Make sure that you and a member of your family or a friend understand exactly when and how to use this medicine before it is needed.

A nurse or other trained health professional may give you Gvoke®. You may also be taught how to give your medicine at home. This medicine is given as a shot under the skin of your stomach, thigh, or upper arm.

A nurse or other trained health professional will give you GlucaGen® as a diagnostic aid during X-ray tests of the stomach and bowels. This medicine is given as a shot into a muscle or into a vein.

This medicine comes with patient instructions together with the kit provided with the package. Read and follow the instructions carefully and ask your doctor if you have any questions.

Gvoke® is available as autoinjector (HypoPen), prefilled syringe, or vial and syringe kit.

Check the liquid in the autoinjector, syringe, or vial. It should be clear and colorless to pale yellow. Do not use it if it is cloudy, discolored, or has particles in it.

Call for emergency medical help right after receiving this medicine.

Drink a fast-acting source of sugar such as a regular soft drink or fruit juice, and eat a long-acting source of sugar (including crackers and cheese or a meat sandwich) as soon as you are able to swallow.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• As an emergency treatment for severe hypoglycemia: For injection dosage form (powder for solution): Adults and children 6 years and older and weighing 25 kilograms (kg) or more—1 milliliter (mL) injected under your skin, into a muscle, or into a vein. The dose may be repeated while waiting for emergency assistance. Children younger than 6 years of age and weighing less than 25 kg—0.5 mL injected under your skin, into a muscle, or into a vein. For injection dosage forms (autoinjector or prefilled syringe): Adults and children 12 years of age and older—1 milligram (mg) or 0.2 milliliter (mL) injected under your skin. An additional dose of 1 mg or 0.2 mL may be repeated if there has been no response after 15 minutes while waiting for emergency assistance. Children 2 to 11 years of age and weighing 45 kg or more—1 mg or 0.2 mL injected under your skin. An additional dose may be repeated if there has been no response after 15 minutes while waiting for emergency assistance. Children 2 to 11 years of age and weighing less than 45 kg—0.5 mg or 0.1 mL injected under your skin. An additional dose may be repeated if there has been no response after 15 minutes while waiting for emergency assistance. Children younger than 2 years of age—Use and dose must be determined by your doctor.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep your medicine and supplies in the original packages until you are ready to use them. Throw away any unused mixed medicine.

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