Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

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.

Citation:

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. https://www.auvi-q.com/. Accessed November 24, 2017.

This Week's Must Reads

USPSTF: Screening for Intimate Partner Violence, JAMA; 2018 Oct 23/30; US Preventive Services Task Force

High HbA1c Variability and Risk of MACE, Diabetes Care; ePub 2018 Oct 23; Ghouse, et al

Omega 3 Polyunsaturated Fatty Acids & Healthy Aging, BMJ; ePub 2018 Oct 17; Lai, Otto, et al

Gaps in HIV PrEP by Race and Ethnicity, MMWR; 2018 Oct 19; Huang, Zhu, et al

Kidney Damage Biomarkers & Incident CKD in BP Reduction, Ann Intern Med; ePub 2018 Oct 23; Zhang, et al

Must Reads in FDA Actions

FDA Approves Steglatro for Adults with T2D, Pfizer news release; 2017 Dec 22

FDA Approves Ozempic for Treatment of T2D, Novo Nordisk news release; 2017 Dec 5

FDA Approves Epinephrine Autoinjector for Infants, Kaléo news release; 2017 Nov 20

FDA Approves Fasenra for Severe Eosinophilic Asthma, AstraZeneca news release; 2017 Nov 14

Shingrix Approved for Prevention of Shingles, GSK news release; 2017 Oct 23