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FDA Approves Epinephrine Autoinjector for Infants

Kaléo news release; 2017 Nov 20

The US Food and Drug Administration has approved AUVI-Q (epinephrine injection, USP) 0.1 mg, the first epinephrine autoinjector for life-threatening allergic reactions in infants and small children. The approval was given to Kaléo Pharma (Richmond, VA).

Indications: AUVI-Q contains epinephrine, a non-selective alpha and beta-adrenergic receptor agonist, indicated in the emergency treatment of allergic reactions (type 1) including anaphylaxis.

Dosage and administration: Inject AUVI-Q intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. Each device is a single-dose injection. Administer as follows:

  • Patients ≥30 kg (66 lbs.): AUVI-Q 0.3 mg.
  • Patients 15 to 30 kg (33 to 66 lbs.): AUVI-Q 0.15 mg.
  • Patients 7.5 to 15 kg (16.5 to 33 lbs.): AUVI-Q 0.1 mg.

Adverse reactions: Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.


U.S. FDA approves Kaléo’s AUVI-Q (epinephrine injection, USP) 0.1 mg auto-injector for life-threatening allergic reactions in infants and small children. [news release]. Kaléo, Richmond, VA. November 20, 2017. Accessed November 24, 2017.

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