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the epinephrine auto-injector approved by the FDA in 2012 for emergency treatment of anaphylaxis and voluntarily withdrawn in 2015 due to potential inaccurate dosage delivery, has become available once more.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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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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A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.

Olopatadine 0.6% nasal spray (Patanase - Alcon) has been approved by the FDA for treatment of seasonal allergic rhinitis in patients ≥ 12 years old. An H1-antihistamine with mast-cell stabilizing activity, olopatadine is already marketed for treatment of allergic conjunctivitis in a 0.1% solution as Patanol and in a 0.2% solution as Pataday. Azelastine (Astelin), another H1-antihistamine with mast-cell stabilizing activity, has been available for intranasal treatment of allergic rhinitis since 1997.

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria, anaphylaxis and asthma (reviewed in Treatment Guidelines 2005; 3:33 and not included here), are prevalent worldwide, especially in industrialized countries. Pharmacologic treatment of these disorders continues to improve in efficacy and safety. In addition to using drugs to prevent and control the symptoms of their allergic diseases, patients should also be instructed to avoid, if possible, specific allergens and/or environmental conditions that trigger or worsen their symptoms.

Allergic rhinitis, allergic conjunctivitis, atopic dermatitis, urticaria and anaphylaxis, along with asthma (reviewed in Treatment Guidelines 2002; 1:7 and not included here), have increased in prevalence during the past 30 years and are now epidemic worldwide, especially in industrialized countries. Many safe and effective drugs are currently available for prevention and relief of symptoms in these disorders, but pharmacological treatment alone may not be sufficient. Patients should also be instructed to avoid specific allergens or environmental conditions that trigger their symptoms. Allergen-specific immunotherapy, parenteral administration of gradually increasing doses of the allergen ("allergy shots"), has been effective in allergic rhinitis, allergic conjunctivitis and allergic asthma, and also in prevention of anaphylaxis triggered by stings from bees, yellow jackets, hornets and wasps. It has not been effective in food allergy, atopic dermatitis or urticaria.

With the coming of spring, direct-to-consumer (DTC) advertisements in newspapers, in magazines and on television are urging people with seasonal allergies to ask their doctors about one or another of the newer, non-sedating antihistamines.

A penicillin is the drug of choice for treatment of many infections, but allergic reactions to these drugs occur frequently and, rarely, can be fatal. From 5% to 20% of patients have a history of a rash or some other reaction while taking a penicillin, but maculopapular rashes with ampicillin or amoxicillin, especially in children with infectious mononucleosis, are probably not allergic.