FDA Approves Zegalogue® (dasiglucagon) Injection to Treat Severe Hypoglycemia in People With Diabetes

The U.S. Food and Drug Administration (FDA) has approved Zegalogue® (dasiglucagon) injection to treat severe hypoglycemia (low blood sugar) in people with diabetes. Zegalogue is approved for people who are 6 years and older.¹

People with diabetes constantly have to monitor their blood sugar to ensure it is in the proper range. When blood sugar dips too low, it is called hypoglycemia, or low blood sugar. Severe hypoglycemia is a life-threatening condition. This can occur when blood sugar (blood glucose) levels drop to dangerous levels. It is not always possible to prevent severe hypoglycemia.¹

Zegalogue will be available by prescription in the United States in June. It will be available in 2 forms: an auto-injector and a prefilled syringe. Zegalogue gives people with diabetes another option to treat severely low blood sugar.¹

What are the ingredients in Zegalogue?

The active ingredient in Zegalogue is dasiglucagon, provided as dasiglucagon hydrochloride.²

How does Zegalogue work?

The active ingredient in Zegalogue tells the pancreas to release glucagon. In turn, glucagon tells cells in the muscle and liver to convert stored energy into glucose. The glucose is then released into the bloodstream to raise blood sugar levels within minutes.²

Evidence for Zegalogue

Zegalogue’s approval was based on results from 3 trials in 219 adults and children with diabetes. The trials were randomized, double-blind, placebo-controlled, and performed at multiple locations. The studies looked at the time to glucose recovery, which was considered an increase in blood sugar by 20 mg/dL or more. In these studies, blood glucose recovered from severe hypoglycemia in 10 minutes with Zegalogue. Time to glucose recovery ranged from 30 to 40 minutes with placebo.^1,2

What are the possible side effects of Zegalogue?

The most common side effects in adults include:^1,2

• Nausea, vomiting, diarrhea
• Headache
• Pain at the injection site

The most common side effects in children include:^1,2

• Nausea and vomiting
• Headache
• Pain at the injection site

Other less common side effects include:²

• High or low blood pressure
• Low blood pressure when going from sitting or lying down to an upright position (orthostatic hypotension)
• Slow heart rate
• Palpitations
• Feeling faint

These are not all the possible side effects of Zegalogue. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Zegalogue.

Things to know about Zegalogue

After Zegalogue has been injected into a person with hypoglycemia, roll them onto their side to prevent choking. Call 911 right away, even if the person wakes up. If the person does not respond to Zegalogue after 15 minutes, another dose may be given.²

Once the person is able to safely eat or drink, give them a fast-acting source of sugar (like fruit juice) and a long-acting source of sugar (like crackers with cheese or peanut butter).²

Hypoglycemia may happen again after treatment with Zegalogue. Early signs of hypoglycemia include:²

• Sweating
• Drowsiness
• Dizziness, lightheadedness
• Irregular heartbeat
• Anxiety, tremor
• Blurred vision
• Slurred speech
• Hunger
• Irritability, depressed mood

Talk to your doctor about how to store and inject Zegalogue. Do not use Zegalogue if:²

• The expiration date has passed
• The gray cap is missing
• The autoinjector appears damaged

There is not enough information to know if Zegalogue is safe to use when pregnant or breastfeeding. Before taking Zegalogue, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.²

Zegalogue may interact with certain drugs. Before beginning treatment for diabetes, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Zegalogue.