The FDA has approved an epinephrine nasal spray (neffy – ARS Pharma) for emergency treatment of type 1 hypersensitivity reactions including anaphylaxis in patients who weigh ≥30 kg. It is the first noninjectable epinephrine product to be approved for this indication.

The FDA has approved a manually injected, single-dose, prefilled epinephrine syringe (Symjepi – Adamis/Sandoz) for emergency treatment of anaphylaxis. The new device is approved in 0.3- and 0.15-mg strengths for treatment of patients weighing ≥30 kg and 15 to 30 kg, respectively; only the 0.3-mg strength is currently available. According to Sandoz, Symjepi will be made available first to institutions and later to the retail market.

Auvi-Q (Kaléo; previously manufactured and marketed by Sanofi), the epinephrine auto-injector approved by the FDA in 2012 for emergency treatment of anaphylaxis and voluntarily withdrawn in 2015 due to potential inaccurate dosage delivery, has become available once more. According to Kaléo, improvements in the manufacturing process have addressed the concerns that led to its recall.

News about recent price increases for EpiPen and EpiPen Jr (Mylan) may have patients asking about other options for emergency treatment of anaphylaxis. Adrenaclick and its generic equivalent (epinephrine injection auto-injector) are the only other epinephrine auto-injectors currently available in the US. According to Impax (the manufacturer of both the brand and generic products), Adrenaclick is no longer being manufactured; the generic product will continue to be marketed after supplies of Adrenaclick are depleted. Auvi-Q (Sanofi), an epinephrine auto-injector that was approved by the FDA in 2013, was removed from the market in 2015 due to inconsistencies in delivery of epinephrine doses, including failure to deliver the drug.1

Adrenaclick and its generic equivalent are similar to EpiPen and EpiPen Jr in size and functionality, but they are not considered interchangeable with the EpiPen products due to differences in device design and instructions for use. One pack (two auto-injectors) of EpiPen or EpiPen Jr costs $608.60. One pack of Impax's generic auto-injectors costs $395.20.2

According to Mylan, generic versions of EpiPen and EpiPen Jr will soon become available at about half the cost of the brand-name products.

1. FDA. Updated: Sanofi US issues voluntary nationwide recall of all Auvi-Q due to potential inaccurate dosage delivery. Available at www.fda.gov. Accessed September 1, 2016.
2. Approximate WAC. WAC = wholesaler acquisition cost or manufacturer's published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. August 5, 2016. Reprinted with permission by First Databank, Inc. All rights reserved. ©2016. www.fdbhealth.com/policies/drug-pricing-policy.

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Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not even comment on the safety or effectiveness of their products beyond the date on the label. Since our last publication on this subject, more data have become available.

A new epinephrine auto-injector is available in the US (Auvi-Q – Sanofi; Allerject in Canada) for emergency treatment of anaphylaxis. The new device is about the length and width of a credit card and as thick as a smartphone. It has a retractable needle system and a red safety guard located at the same end as the needle. Activation of the device by removing the outer case initiates an audio voice recording that provides step-by-step instructions and a 5-second countdown during the injection. The shelf-life of the epinephrine in the auto-injector is 18 months; the shelf-life of the battery is longer.

Auvi-Q’s needle length, gauge and injection force are similar to those of EpiPen. A randomized, crossover, bioavailability study found that injection of epinephrine 0.3 mg from Auvi-Q and EpiPen resulted in similar peak epinephrine levels and total epinephrine exposure.1 Like EpiPen, Auvi-Q is available in 2 doses: 0.15 mg (for children weighing 15-30 kg) and 0.3 mg. The cost for 2 Auvi-Qs containing either 0.15 mg or 0.3 mg is $241, compared to $240.66 for an EpiPen Jr or EpiPen 2-Pak.2

CONCLUSION — Auvi-Q is a new, smaller epinephrine auto-injector that provides audio instructions as it is being used. It appears to be more convenient to carry and easier to use than EpiPen.

1. ES Edwards et al. J Allergy Clin Immunol 2012;129:AB179, abstract 678.

2. Wholesale acquisition cost (WAC). Source: $ource® Monthly (Selected from FDB MedKnowledge™) February 5, 2013. Reprinted with permission by FDB, Inc. All rights reserved. ©2013. www.fdbhealth.com/policies/drug-pricing-policy. Actual retail prices may vary.

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