Glucagon Emergency Kit (Injection)

Glucagon injection is an emergency medicine used to treat severe hypoglycemia (low blood sugar) in diabetes patients who use insulin and have lost consciousness or cannot take 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 symptoms of hypoglycemia (low blood sugar). These symptoms can appear quickly and may happen due to:

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

If not treated, hypoglycemia can lead to unconsciousness, seizures, and possibly death. Early symptoms of hypoglycemia include: feeling anxious, acting like you are drunk, blurred vision, cold sweats, confusion, cool pale skin, trouble concentrating, drowsiness, extreme hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.

Symptoms of hypoglycemia can vary from person to person. It is 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 how to respond if you experience symptoms of low blood sugar. Eating or drinking something with sugar when symptoms first appear usually stops them from getting worse and likely makes 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 have a light snack, like crackers and cheese or half a sandwich, or drink a glass of milk to 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 fat slows down the sugar from getting into your bloodstream. After 10 to 20 minutes, check your blood sugar again to make sure it is not still too low.

If your 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, ringing in the ears, or a slow or fast heartbeat. These may be signs of 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 have 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). Check with your doctor right away if you have blistering, peeling, or a red skin rash on your face, groin, buttocks, or legs.

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

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

• After the injection, turn the patient on 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. Get the patient to a doctor or hospital emergency care as soon as possible because being unconscious for too long can be harmful.
• When the patient is conscious and can swallow, give them some form of sugar. Glucagon is effective for only about 1½ hours and is used until the patient can swallow. Fruit juice, corn syrup, honey, and sugar cubes or table sugar (dissolved in water) all work quickly. 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. This will help prevent hypoglycemia from happening again before the next meal or snack.
• The patient or caregiver should continue to monitor 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 episodes of hypoglycemia or use of glucagon, even if symptoms are controlled and there seem to be no ongoing issues. Complete information is necessary for the doctor to provide the best treatment for any condition.

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

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

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it will provide. Here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems that would limit the use of GlucaGen® for treating severe hypoglycemia in children. However, the safety and effectiveness of glucagon injection as a diagnostic tool have not been established.

Studies done so far have not shown any specific problems that would limit the use of 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 old.

Geriatric

No studies have been conducted to assess how age affects the effects of Gvoke® in older adults. However, no specific problems related to older adults have been documented so far.

There is no information available regarding how age affects the effects of GlucaGen® in older patients.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together despite possible interactions. In these cases, your doctor may need to 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 have been selected based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the 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 at mealtime or with certain types of food because interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions can affect how this medicine works. Make sure to tell your doctor if you have any other medical problems, 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 tumor of the pancreas) or
• Insulinoma (pancreas tumor) or
• Pheochromocytoma (tumor of the adrenal gland)—This medicine should not be used in patients with these conditions.

• Coronary artery disease or
• Diabetes mellitus or
• Heart disease—Use this medicine with caution. It may worsen these conditions.

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

Check with your doctor immediately 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. 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:

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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