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. https://www.auvi-q.com/. Accessed November 24, 2017.
This Week's Must Reads
Antibiotic Use Among US Older Adults, BMJ; ePub 2018 Jul 27; Olesen, Barnett, et al
Healthy Behaviors & Reduced Risk of Obesity , Mayo Clin Proc; ePub 2018 Jul 27; Shook, et al
Modifiable Risk Factors in New BP Categories, Am J Med; ePub 2018 Jul 26; Gu, Yue, et al
Psychological Screening for Youth with Abdominal Pain, Pediatrics; ePub 2018 Jul 25; Cunningham, et al
Low-Calorie Sweetened Beverages & Cardiometabolic Health, Circulation; ePub 2018 Jul 30; Johnson, 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