FDA Approves Treatment of Severe Hypoglycemia That Does Not Need Reconstitution

The FDA approved Gvoke Kit for the treatment of hypoglycemia in pediatric and adult patients with diabetes 2 years of age and older. The ready-to-use, room temperature, stable liquid glucagon is administered into the lower abdomen, outer thigh, or outer upper arm, and does not require reconstitution.

Gvoke Kit is available as 1 mg/0.2 mL single-dose vial and syringe kit. Gvoke Kit contains 1 single-dose sterile syringe with markings for 0.1 mL (the pediatric 0.5-mg dose) and 0.2 mL (adult 1-mg dose), and one single-dose vial containing 0.2 mL of solution.

Gvoke is a product of Xeris Pharmaceuticals. Gvoke Kit will be available in addition to the company’s previously approved glucagon formulations, the single-dose prefilled syringe Gvoke HypoPen and the autoinjector Gvoke PFS.

Prescribing information is available.

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