First Pre-Measured Low Blood Sugar Treatment Approved Leave a comment


(RxWiki News) Treating severe low blood sugar doesn’t have to be complex and overwhelming. And a newly approved treatment may make things even easier.

The US Food and Drug Administration (FDA) has approved Gvoke (glucagon) to be used in emergency instances of severe low blood sugar (hypoglycemia). This new approval, intended for those over the age of 2 who have diabetes, includes the following:

  • Gvoke HypoPen
  • Gvoke PFS (a pre-filled syringe)

Before this new approval, the available treatment was a glucagon emergency kit that involved the mixing of a powder and liquid with a syringe. This process can be overwhelming and complicated — especially during an emergency blood sugar situation.

These two new glucagon options are ready to use and do not require mixing. They are both pre-mixed, pre-filled and pre-measured for easy administration.

The FDA approved two doses:

  • 0.5 mg/0.1 mL dose for pediatric patients
  • 1 mg/0.2 mL dose for adolescents and adults

“Until now, many people may have been hesitant to use conventional glucagon kits because the complex preparation felt confusing and perhaps overwhelming,” said Jeff Hitchcock, founder and president of Children with Diabetes, in an article for Beyond Type 1. “With Gvoke as a new glucagon option, we gain an easy to use and effective solution to a dangerous and stressful event.”

During an emergency situation, Gvoke is administered into the fatty layer under the skin (subcutaneously). The pre-filled syringe is expected to be available in the next few weeks (October 2019). The auto-injector is expected to be available in 2020.

What will these options cost? This new approval will cost $280 (price before insurance), according to Beyond Type 1. The insurance details have not been determined.

In addition to Gvoke, the FDA approved Baqsimi, a nasal powder to treat severe low blood sugar, this past July. For more information on this approval, be sure to read “Approved: Rx for Severe Low Blood Sugar.”

Common side effects of this new approval include nausea, vomiting, injection site reactions, headache, stomach pain and high blood sugar.

This new approval is not for everyone. Your doctor will determine whether this new glucagon treatment option is right for you.

The FDA granted this approval to Xeris Pharmaceuticals.

Written by Anyssa Garza, PharmD, BCMAS


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