Glucagon Diagnostic Kit (Injection)

Glucagon injection is an emergency medicine for treating severe hypoglycemia (low blood sugar) in diabetes patients who use insulin and have passed out or cannot take sugar by mouth.

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

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
• illness (especially if vomiting or diarrhea occurs)
• exercising more than usual.

If not treated, hypoglycemia can lead to unconsciousness, seizures, and possibly death. Early signs of hypoglycemia include: feeling anxious, behaving like you are drunk, having blurred vision, experiencing cold sweats, feeling confused, having cool pale skin, struggling to concentrate, feeling drowsy, having excessive hunger, experiencing a fast heartbeat, having a headache, feeling nauseous, being nervous, having nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.

Signs of hypoglycemia can vary from person to person. It is important to learn 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 the signs first appear will usually stop them from getting worse and will likely 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 have a light snack, like crackers and cheese, half a sandwich, or a glass of milk to prevent 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 from entering your bloodstream. After 10 to 20 minutes, check your blood sugar again to make sure it is not still too low.

If the signs 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 immediately if you have blurred vision, dizziness, nervousness, headache, pounding in your 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 lightheadedness, dizziness, or fainting while receiving this medicine.

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

If severe signs, including seizures or unconsciousness occur, the patient with diabetes should not be given anything to eat or drink. There is a risk that he or she could choke if they cannot swallow properly. Glucagon should be administered 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 onto their left side. Glucagon may cause some patients to vomit, and this position will help prevent choking.
• The patient should regain consciousness within 15 minutes after glucagon is injected, but 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.
• Once the patient is conscious and can swallow, give them some form of sugar. Glucagon is effective for only about 1½ hours and is used only until the patient can swallow. Options include fruit juice, corn syrup, honey, and sugar cubes or table sugar (dissolved in water). Then, if a snack or meal is not scheduled for an hour or more, the patient should also have some crackers and cheese, half a sandwich, or a glass of milk. This will help 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, the blood sugar should be checked every hour.
• If nausea and vomiting make it impossible for the patient to swallow some form of sugar for an hour after glucagon is given, seek medical help.

Keep your doctor updated on any episodes of hypoglycemia or use of glucagon, even if the signs are controlled and there do not seem to be ongoing issues. Complete information is necessary for your doctor to provide the best treatment.

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, carry an ID card that lists your medical condition and medications.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it may provide. The following points should be taken into account:

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 provider know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients closely.

Pediatric

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

Research so far has not shown any specific problems in children aged 2 years and older that would limit the effectiveness of Gvoke® for treating severe hypoglycemia. However, safety and effectiveness have not been established in children younger than 2 years.

Geriatric

No studies have been done to look at how age affects the use of Gvoke® in older adults. However, there have been no specific problems reported so far for older patients.

There is no information 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 while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication if you are breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might want to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are highlighted based on their potential significance and are not necessarily all-inclusive.

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 take 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

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Adrenal insufficiency or
• Chronic hypoglycemia or
• Prolonged fasting or starvation—Should be treated with glucose in patients with these conditions.

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

• Coronary artery disease or
• Diabetes mellitus or
• Heart disease—Use with caution. May worsen these conditions.

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 happen 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 how 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 can 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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