Pronunciation:

GLOO-ka-gon

Brand Names:

• Baqsimi

Dosage Forms:

• Powder

Classifications:

Therapeutic—

Glucose Regulation, Antihypoglycemic

Uses of This Medicine:

Glucagon nasal powder is used to treat severe hypoglycemia (low blood sugar) in diabetes patients 4 years of age and older.

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

Before Using This Medicine:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of glucagon nasal powder to treat severe hypoglycemia in children 4 years of age and older. However, safety and efficacy of glucagon nasal powder have not been established in children younger than 4 year of age.

Older adults—

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

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.

Other 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 is usually not recommended, but may be required 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

Other interactions—

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:

• Heart disease—Use with caution. May make this condition worse.

• Insulinoma (pancreas tumor) or
• Pheochromocytoma (adrenal gland tumor) or
• Prolonged fasting or starvation—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Glucagon nasal powder is an emergency medicine and must be used only as directed by your doctor. Make sure your caregiver or family member knows where you keep your Baqsimi™ device and that they know how to use it the right way before you need their help.

This medicine is for use only in the nose. Do not get any of it in the eyes or on the skin. If it does get on these areas, rinse it off right away.

This medicine comes with patient information leaflet and patient instructions. Read and follow the instructions carefully and ask your doctor if you have any questions.

To use the nasal powder:

• Each intranasal device contain only one dose of glucagon. Do not prime or test the device.
• Remove the shrink wrap by pulling on the red stripe. Open the lid and remove the nasal device from the tube.
• Hold the nasal device between your fingers and thumb.
• Gently insert the tip of the device into one nostril, until fingers touch the outside of the nose.
• Press the plunger firmly to give the dose. The dose does not need to be inhaled.
• Remove the nasal device from the nose. After giving the dose, call for emergency medical help right away.
• Drink a fast-acting source of sugar such as a regular soft drink or fruit juice, and eat a snack (such as crackers with cheese or peanut butter) as soon as the patient is 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 nasal dosage form (powder):
  • For severe hypoglycemia:
    • Adults and children 4 years of age and older—3 milligrams (mg) (1 intranasal device in one nostril). An additional dose of 3 mg may be given if there has been no response after 15 minutes.
    • Children younger than 4 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 Baqsimi™ device in the shrink wrapped tube until ready to use. Throw away Baqsimi™ device and tube after use.

Precautions While Using This 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 given and the patient's doctor should be called at once.

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.

This medicine may cause a serious allergic reaction, called anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, any swelling of your hands, face, or mouth, or lightheadedness or fainting after receiving this medicine.

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.

Side Effects of This Medicine:

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:

Incidence not known

Blurred vision

cough

difficulty with swallowing

dizziness

fast, pounding, or irregular heartbeat or pulse

headache

hives, itching, skin rash

nervousness

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

slow heartbeat

tightness in the chest

trouble breathing

unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Nausea

vomiting

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

Bloody nose

body aches or pain

chills

ear congestion

fever

loss of voice

redness of the eyes

sneezing

sore throat

stuffy or runny nose

watery eyes

Incidence not known

Change or loss of taste

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.