FDA Approves First Generic Drug Used to Treat Severe Hypoglycemia

The U.S. Food and Drug Administration (FDA) has approved the first generic glucagon for injection to treat severe hypoglycemia (very low blood sugar). The glucagon injection is packaged in an emergency kit.1

Despite being used for more than 20 years, no generic version of the drug was available.1

How does emergency glucagon work to treat severe hypoglycemia?

Severe hypoglycemia occurs when blood sugar goes so low that a person becomes confused or even unconscious. The person can also have blurred vision or abnormal behavior. When this happens, it is typically in someone with diabetes who uses insulin to treat it. Hypoglycemia is a medical emergency and should be treated as quickly as possible.1,2

The generic version of glucagon is a synthetic version of human glucagon. Glucagon is a hormone that works with other hormones and bodily functions to help regulate blood glucose levels. It tells the liver to quickly increase blood sugar levels.1,3

Blood glucose levels rise within 10 minutes of injection and reach their highest levels about 30 minutes after injection.2

Why is this an important approval for people with diabetes?

Sometimes more complex products like glucagon can be harder to make because of their active ingredient, formulation, or mode of delivery. This results in no generic being made, even when the patent for the brand-name drug runs out.1

For more than 2 decades, the glucagon emergency treatment for severe hypoglycemia was brand-name only. This made it more expensive, even with insurance, and therefore less accessible to people. The new generic version of glucagon means more people can afford it and have it on hand if they need it.1

Glucagon was the list of FDA of off-patent, off-exclusivity drugs without an approved generic. This list was made to improve transparency and encourage the development and submission of drug applications with minimal competition. Generic drugs are examined, just like any other drug, to ensure their safety and efficacy as compared to their brand-name counterparts.1

The main new thing about the generic version of glucagon means that more people will be able to afford it. The lower price means it will be more accessible to those who need it. Even with insurance, glucagon could be expensive. The generic version means glucagon will have a much lower copay if you have insurance.1

What are the possible side effects of emergency glucagon?

Common side effects with a glucagon injection may include:1,2

  • Nausea, vomiting, diarrhea
  • Headache
  • Weakness
  • Redness and swelling at the injection site

Get emergency medical care if you have signs of an allergic reaction to glucagon, including:3

  • Rash
  • Difficulty breathing
  • Low blood pressure
  • Swelling of the face, lips, tongue, or throat

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

Things to know about emergency glucagon

Hypoglycemia is a medical emergency that should be treated as quickly as possible. Glucagon should be used to treat hypoglycemia only if the person cannot eat, passes out, or is having a seizure.1,2

If you have diabetes, someone close to you (spouse, caregiver, friend, etc.) will need to be trained in the proper way to give an emergency glucagon injection. If you have given a glucagon injection to someone with diabetes, get emergency medical help for them as quickly as possible afterward.1,2

People who are allergic to glucagon or lactose or those who have a tumor of the pancreas or adrenal gland should not use a glucagon injection.1,2

If your doctor has prescribed glucagon for an emergency, talk with them about the new generic approval and what it means for you.

For more information, read the full prescribing information for glucagon for injection.

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