Pronunciation:

das-i-GLOO-ka-gon

Brand Names:

• Zegalogue

Dosage Forms:

• Solution

Uses of This Medicine:

Dasiglucagon injection is an emergency medicine used to treat severe hypoglycemia (low blood sugar) in diabetes patients treated with insulin who have passed out or cannot take some form of sugar by mouth.

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 dasiglucagon injection to treat severe hypoglycemia in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Older adults—

Appropriate studies on the relationship of age to the effects of dasiglucagon injection have not been performed in the geriatric population.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Adrenal insufficiency or
• Hypoglycemia, chronic or
• Prolonged fasting or starvation—Should be treated with glucose in patients with these conditions.

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

Proper Use of This Medicine:

Dasiglucagon 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 is given as a shot under the skin of your lower stomach, buttocks, thighs, or outer upper arms.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Do not use this medicine if the liquid is discolored or has particles in it.

Call for emergency medical help right after giving or receiving this medicine.

Drink a fast-acting source of sugar (including fruit juice) and eat a long-acting source of sugar (including crackers with cheese or peanut butter) as soon as you are able to swallow.

The cap of the autoinjector and the needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex.

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 forms (autoinjector or prefilled syringe):
    • Adults and children 6 years of age and older—0.6 milligram (mg) injected under your skin. An additional dose of 0.6 mg 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 in the refrigerator. Do not freeze.

This medicine can also be stored at room temperature for up to 12 months. Do not return it to the refrigerator after storing at room temperature. Throw away any unused medicine if it has been stored at room temperature for more than 12 months.

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, 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 dasiglucagon 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.

Tell your doctor right away if you have blurred vision, dizziness, nervousness, headache, pounding in the ears, or slow or fast heartbeat. These may be symptoms 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, any swelling of your hands, face, or mouth, or lightheadedness, dizziness, or fainting while you are receiving this medicine.

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

• After the injection, turn the patient on his or her left side. dasiglucagon 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 dasiglucagon 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. Dasiglucagon 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 dasiglucagon is given, medical help should be obtained.

Keep your doctor informed of any hypoglycemic episodes or use of dasiglucagon 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 dasiglucagon as soon as possible, in case another hypoglycemic episode occurs.

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

chest pain, discomfort, or tightness

confusion

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast, irregular, pounding, or racing heartbeat or pulse

headache

itching, skin rash

lightheadedness, dizziness, or fainting

loss of consciousness

nervousness

pounding in the ears

slow or fast heartbeat

swelling of the eyes or eyelids

sweating

trouble breathing

unusual tiredness or weakness

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 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

diarrhea

nausea

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.