Glucagon Diagnostic Kit

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

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glucagon injection to treat severe hypoglycemia in children. However, safety and efficacy of glucagon injection have not been established to be used as a diagnostic aid.

Geriatric

No information is available on the relationship of age to the effects of glucagon injection in geriatric patients.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Dicumarol
• Phenindione
• Phenprocoumon
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Coronary artery disease or
• Glucagonoma (a rare type of pancreas tumor) or
• Heart disease—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain glucagon. It may not be specific to Glucagon Diagnostic Kit. Please read with care.

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.

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.

Do not use this medicine if a gel has formed, or if you see particles in the mixed solution.

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 (such as 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.

• For injection dosage form:
  • As an emergency treatment for severe hypoglycemia:
    • 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.

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.

Throw away any unused mixed medicine.

Patients with diabetes should be aware of the symptoms of hypoglycemia (low blood sugar). These symptoms may develop in a very short time and may result from:

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

Unless corrected, hypoglycemia will lead to unconsciousness, convulsions (seizures), and possibly death. Early symptoms of hypoglycemia include: anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, fast heartbeat, headache, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness.

Symptoms of hypoglycemia can differ from person to person. It is important that you learn your own signs of low blood sugar so that you can treat it quickly. It is a good idea also to check your blood sugar to confirm that it is low.

You should know what to do if symptoms of low blood sugar occur. Eating or drinking something containing sugar when symptoms of low blood sugar first appear will usually prevent them from getting worse, and will probably 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 keep your blood sugar from going down again. You should not eat hard candy or mints because the sugar will not get into your blood stream quickly enough. You also should not eat foods high in fat such as chocolate because the fat slows down the sugar entering the blood stream. After 10 to 20 minutes, check your blood sugar again to make sure it is not still too low.

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

If severe symptoms such as convulsions (seizures) or unconsciousness occur, the patient with diabetes should not be given anything to eat or drink. There is a chance that he or she could choke from not swallowing correctly. Glucagon should be administered and the patient's doctor should be called at once.

If it becomes necessary to inject glucagon, a family member or friend should know the following:

• After the injection, turn the patient on his or her left side. Glucagon may cause some patients to vomit and this position will reduce the possibility of choking.
• The patient should become conscious in less than 15 minutes after glucagon is injected, but if not, a second dose may be given. Get the patient to a doctor or to hospital emergency care as soon as possible because being unconscious too long can be harmful.
• When the patient is conscious and can swallow, give him or her some form of sugar. Glucagon is not effective for much longer than 1½ hours and is used only until the patient is able to swallow. Fruit juice, corn syrup, honey, and sugar cubes or table sugar (dissolved in water) all work quickly. Then, 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 prevent hypoglycemia from occurring 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, the blood sugar should be checked every hour.
• If nausea and vomiting prevent the patient from swallowing some form of sugar for an hour after glucagon is given, medical help should be obtained.

Keep your doctor informed of any hypoglycemic episodes or use of glucagon even if the symptoms are successfully controlled and there seem to be no continuing problems. Complete information is necessary for the doctor to provide the best possible treatment of 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. In addition, you should carry an ID card that lists your medical condition and medicines.

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.