FDA Approves First Epinephrine Auto-Injector for Infants

approved with pill bottle
Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Life-threatening allergic reactions are scary no matter what age you are. In the past, there were no epinephrine auto-injectors available for infants and small children. However, the FDA has just approved a new lower dose of Auvi-Q, specifically designed for use in children weighing 16.5 to 33 pounds.

What strengths will Auvi-Q be available in?

Auvi-Q will now be available in strengths of 0.3 mg, 0.15 mg, and 0.1 mg. The 0.3 mg dose is indicated for patients who weigh greater than or equal to 66 pounds, and the 0.15 mg dose is indicated for patients who weigh 33 to 66 pounds. The new 0.1 mg dose is indicated for patients who weigh 16.5 to 33 pounds.

Additionally, Kaleo, the manufacturer, developed the 0.1 mg autoinjector with a shorter needle length to ensure that the injector won’t strike bone in a small child.

When will the Auvi-Q 0.1 mg auto-injector be available?

According to the press release from kaléo, the Auvi-Q 0.1 mg auto-injector is projected to be available for patients in the first half of 2018.

How can I save on Auvi-Q?

The manufacturer, Kaleo pharmacy, created the Auvi-Q Affordability programfirst-of-its-kind access program for the product. The program boasts a $0 out of pocket for all commercially insured patients, including those with high-deductible plans. There is also the Kaléo Cares Patient Assistance Program to help patients who are experiencing financial difficulties receive Auvi-Q at no cost.

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