An Overview of Zegalogue

Zegalogue (dasiglucagon) is a prescription medication used to treat severe hypoglycemia (very low blood sugar) in people with diabetes ages 6 and older. It comes as a prefilled pen or single-use syringe. It was approved by the Food and Drug Administration (FDA) in 2021.

The injection delivers glucagon in the form of a premixed solution. This is different from traditional glucagon kits, which require you to mix a solution and inject it using a syringe.

Learn more in this article, including uses, precautions, dosage, modifications, side effects, and interactions.

Uses

Severe low blood sugar can happen to people with diabetes. This especially happens in those who take glucose-lowering medication such as insulin. Normally, low blood sugar, defined as a blood glucose of less than 70 mg/dL, can be treated with fast-acting carbohydrate.

The number for a dangerously low blood sugar varies from person to person. When blood sugars drop dangerously low, the brain does not get enough glucose and stops functioning as it should. Prolonged hypoglycemia can result in seizures, unresponsiveness, or even coma.

A hypoglycemic event occurs when blood sugars cannot be raised using traditional treatment. This needs to be treated with glucagon.

Glucagon is a hormone produced by the pancreas that is activated when blood sugars drop. It signals the body to release stored glucose from the liver so that blood sugars may rise.

The FDA-approved Zegalogue is based on three randomized, double-blind, placebo-controlled multicenter phase 3 studies. They measured how long it took for blood sugars to rise 20 mg/dL or more after Zegalogue administration. The trials included children (aged 6 to 17) and adults with type 1 diabetes.

Researchers found that blood glucose rose within 10 minutes following Zegalogue administration, compared to 30-45 minutes in placebo. In the main phase 3 adult trial, 99% of patients recovered within 15 minutes.

Before Taking

Low blood sugar can have symptoms including shaking, sweating, confusion, and hunger. Treatment typically includes ingesting 15 grams of fast-acting carbohydrate (such as four ounces of juice) and then retesting blood sugar in 15 minutes to make sure it has gone up.

This is called the “Rule of 15.” If necessary, this process is repeated until blood sugars get to a safe range or at least above 70 mg/dL.

Your blood sugar can drop so low that your brain is not functioning properly. If you are unable to ingest glucose, you need someone to help you recover.

Glucagon can be administered by a loved one or caregiver to bring blood sugars up quickly. Zegalogue should be administered if someone is having low blood sugar and is unable to swallow, is unresponsive or unconscious, or is having a hypoglycemic seizure.

American Diabetes Association (ADA) standards of care address the treatment of hypoglycemia. They say all people with type 1 diabetes should have some form of glucagon immediately available in case of an emergency.

The ADA defines level 2 hypoglycemia as a blood glucose concentration greater than 54 mg/dL (3.0 mmol/L). This is the threshold at which symptoms related to the brain’s lack of glucose begin to occur. It requires immediate action to resolve the hypoglycemic event.

Level 3 hypoglycemia may be recognized or unrecognized and can progress to loss of consciousness, seizure, coma, or death.

Zegalogue is approved in people ages 6 and up. Other forms of glucagon, such as certain glucagon kits, are suitable for children younger than 6 years of age.

Talk to your healthcare provider about all medications, supplements, and vitamins that you currently take. While some drugs pose minor interaction risks, others may outright contraindicate use. Or, they may prompt careful consideration as to whether the pros of treatment outweigh the cons in your case.

Precautions and Contraindications

People with type 1 diabetes who have additional conditions or sensitivities should not take Zegalogue:

• Pheochromocytoma: People who have pheochromocytoma (a rare, usually benign tumor on the adrenal gland) cannot use Zegalogue. There is a risk of an increase in blood pressure.
• Insulinoma: This is a tumor in the pancreas that produces excess insulin. Zegalogue causes blood sugar to go up initially. This might stimulate the insulinoma to release more insulin and cause hypoglycemia.
• Known hypersensitivity to glucagon or any inactive ingredients: If you know you are allergic to glucagon or any other ingredients in Zegalogue, you should not take it. Allergic reactions that have been reported include a rash. In some cases, anaphylactic shock with breathing difficulties and low blood pressure can occur.
• Starvation state, adrenal insufficiency, or chronic hypoglycemia: In these instances, the body may not have sufficient glycogen stores to raise blood sugar. Hypoglycemia will need to be treated with glucose.

Other Forms of Glucagon

Other forms of glucagon that can be prescribed to people with diabetes include GlucaGen, Gvoke, and Baqsimi (an inhaled form of glucagon).

Amphastar Pharmaceuticals also has a generic glucagon kit. Some of these forms of glucagon are approved in younger kids (less than 6 years of age) with diabetes.

Dosage

According to the manufacturer, dosages include 0.6 milligrams/milliliter (mg/dL) single-dose autoinjector or 0.6 mg/mL single-dose prefilled syringe.

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your healthcare provider to make sure you are taking the right dose for you.

Modifications

If you are over the age of 65, pregnant, or breastfeeding, consult with your healthcare provider about this medication. As per the manufacturer, clinical studies included too few patients 65 years of age and older to determine whether these patients respond differently from younger adult patients.

Since there is no available data on Zegalogue use in pregnancy, it hasn’t been evaluated for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. It is also unclear if the medication gets into breastmilk.

Additionally, the safety and efficacy of the drug have not been established in children less than 6 years of age.

How to Take and Store

Zegalogue can be stored in the refrigerator 36 F to 46 F (2 C to 8 C) or at room temperature 68 F to 77 F (20 C to 25 C) for up to 12 months in the red protective case it comes in. Do not freeze this medicine. Once it is taken out of the refrigerator, it cannot be put back in.

After 12 months, the medication should be discarded. This medication should be kept out of the reach of children.

In the case of a hypoglycemic event where you cannot give yourself this medication, a loved one or caregiver will give it to you. The instructions will vary slightly depending on if you have the autoinjector or prefilled syringe.

Do not use Zegalogue if it is expired, the gray needle cover is missing, or the syringe is damaged. In addition, you should not give Zegalogue if the solution is discolored or contains any particles or matter.

Before injecting, the caregiver should turn a person on their side to prevent choking (in the event that they vomit).

Autoinjector:

• Hold the red protective case upright with the gray lid on top. Pull the gray lid up to open and remove the medicine from the red protective cap without dropping it.
• Before injecting, choose the injection site: the buttocks, lower abdomen (2 inches away from the belly button), front or back of thighs.
• Do not inject through the clothes. Clothes must be pulled away to expose skin.
• Pull off the gray cap, make sure you do not put your fingers by the yellow needle guard because you can get stuck with the needle.
• Place the needle on the person you are administering medicine to and push straight down. Hold for 10 seconds until the check window is red. You may hear the first click. After you have held it in place for 10 seconds, you may hear a second click. The medicine window should be fully red so that you can be assured you gave the full dose.
• Remove the needle from the injection site. The yellow needle guard will cover the needle and lock, preventing an accidental needle stick.
• If you have not done so already, make sure the person is lying on their side.

Single-dose prefilled syringe:

• Hold the red protective case upright with the gray cap on top. Pull the gray cap up to open. Carefully remove Zegalogue from the red protective case without dropping it.
• Before injecting, choose the injection site: the buttocks, lower abdomen (2 inches away from the belly button), front or back of thighs.
• Do not inject through the clothes. Clothes must be pulled away to expose skin.
• Pull the gray needle cover straight off. Be careful not to bend the needle. 
• Gently pinch the skin and insert the entire needle into the skin at a 45-degree angle. 
• After inserting the needle, release the pinched skin and slowly press the plunger rod all the way down until the syringe is empty and the plunger rod stops. 
• After the plunger rod stops and the injection is complete, carefully remove the needle from the injection site. 
• If you have not done so already, make sure the person is lying on their side.

Call for emergency medical help or a healthcare professional right away after you have injected Zegalogue. Even if it appears that the medicine has worked, you should still call for help. As per the manufacturer, if the person does not respond after 15 minutes, another dose can be given, if available.

Once the person can eat or drink, they should be given a fast-acting carbohydrate such as juice and a long-acting carbohydrate with protein to prevent more hypoglycemia. This may include cheese and crackers or crackers and peanut butter.

This medicine can only be used one time and should be discarded in a sharps container once finished. Once the dose is used, make sure you receive another prescription to have in case of another emergency.

You should be able to travel with this medication. The Transportation Safety Administration (TSA) allows diabetes medications and liquids during travel. Alert the TSA officer, and you will go through a separate screening.

Side Effects

After the injection, you may experience certain side effects.

Common

Common side effects include nausea, vomiting, diarrhea, and pain at the injection site. According to the manufacturer, other adverse reactions occurring within 12 hours of treatment include:

• Hypertension (high blood pressure)
• Hypotension (low blood pressure)
• Bradycardia (slow heartbeat)
• Presyncope (lightheadedness)
• Palpitations (feeling unusual heartbeat)
• Orthostatic intolerance (abnormal response to being upright)

Severe

Severe side effects are rare but can occur. These side effects include having an allergic reaction, which may present as a generalized rash. In some cases, anaphylactic shock with breathing difficulties and low blood pressure may occur. If you have any of these symptoms, you should seek medical attention right away.

Overdosage can result in nausea, vomiting, inhibited digestive tract motility, and/or increases in blood pressure and heart rate. The appropriate treatment should be based on the person’s symptoms.

Warnings and Interactions

Certain medications can interact with Zegalogue. These include beta blockers, indomethacin, and warfarin:

• Beta blockers: People taking beta blockers may experience a transient increase in blood pressure and pulse.
• Indomethacin: This nonsteroidal anti-inflammatory drug (NSAID) is commonly used to treat pain in arthritis and various other conditions. If you take indomethacin and need glucagon, your body may not be able to raise blood sugar. You’ll experience hypoglycemia instead. Talk to your healthcare provider about hypoglycemia treatment if you are taking this medication.
• Warfarin: Zegalogue may increase the anticoagulant (blood-thinning) effect of warfarin.

In addition, if you are pregnant, older than 65, or breastfeeding, you should ask your healthcare provider about Zegalogue and its effects before getting a prescription.

For children with type 1 diabetes, it should be noted that Zegalogue is approved for ages 6 and older.

Zegalogue should only be used once and then discarded. It can be given by a healthcare professional, school personnel, or caregiver. All people who are prescribed Zegalogue should be educated on the signs, symptoms, and treatment of hypoglycemia, proper storage, and medication use.

Summary

Zegalogue is a new premixed form of glucagon approved by the FDA to treat severe hypoglycemia in people with diabetes ages 6 and older. Untreated hypoglycemia can progress quickly and cause a hypoglycemic event, which may require a glucagon injection.

The American Diabetes Association recommends glucagon be prescribed for all individuals at increased risk of level 2 or 3 hypoglycemia so that it is available should it be needed.

People with diabetes and their caregivers need to understand the signs, symptoms, and treatment of hypoglycemia. They should also be educated on proper storage, injection technique, warnings, and contraindications of Zegalogue. If there are any doubts about how to use this medication or if it is necessary, you should discuss it with your healthcare provider.