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the epinephrine auto-injector approved by the FDA in 2012 for emergency treatment of anaphylaxis and voluntarily withdrawn in 2015 due to potential inaccurate dosage delivery, has become available once more.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.

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...

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...

The FDA has approved a 1-mg epinephrine nasal spray (neffy - ARS Pharma) for emergency treatment of type 1 hypersensitivity reactions including anaphylaxis in patients ≥4 years old who weigh 15 to <30 kg. A 2-mg formulation of neffy was approved in 2024 for use in patients who weigh ≥30 kg.

The FDA has approved a lower-dose epinephrine auto-injector (Auvi-Q 0.1 mg – Kaléo) for emergency treatment of anaphylaxis in children weighing 7.5-15 kg (16.5-33 lbs). It is the first epinephrine auto-injector to be approved for use in infants and toddlers weighing less than 15 kg. Previously, Auvi-Q and other epinephrine auto-injectors were only available in 0.15- and 0.3-mg strengths for patients weighing 15-30 kg or ≥30 kg, respectively.The recommended dose of epinephrine for intramuscular (IM) or subcutaneous (SC) administration is 0.01 mg/kg. None of the previously available...

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 comment on the safety or effectiveness of their products beyond the date on the label. Since our last article on this subject, more data have become available.

Cardiac arrest may be due to tachyarrhythmias, bradyarrhythmias, or asystole. Without treatment, permanent damage to the cerebral cortex usually begins within five minutes and is complete in ten. After cardiopulmonary resuscitation (CPR) has been started and electrical defibrillation, when indicated, has been applied, drugs may help promote recovery.

The FDA has approved over-the-counter (OTC) sale of inhaled epinephrine (Primatene Mist – Amphastar), a nonselective alpha and beta agonist, for temporary relief of mild symptoms of intermittent asthma in patients ≥12 years old who have been diagnosed with mild intermittent asthma by a healthcare professional. The original version of Primatene Mist, which was approved by the FDA in 1967, was removed from the market in 2011 because the metered-dose inhaler (MDI) contained ozone-depleting chlorofluorocarbon (CFC) propellants; the new MDI contains hydrofluoroalkane (HFA)...