Omalizumab (Xolair – Genentech), a recombinant anti-IgE monoclonal antibody FDA-approved for treatment of allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic urticaria, has now also been approved for use in conjunction with food allergen avoidance to reduce IgE-mediated food allergic reactions caused by accidental exposure in patients ≥1 year old. Omalizumab is the first drug to be approved in the US to reduce allergic reactions to more than one food. Palforzia, an oral peanut allergen powder, was approved in 2020 to mitigate allergic reactions caused by accidental peanut exposure in patients with a confirmed peanut allergy.

The FDA has approved opicapone (Ongentys – Neurocrine), a peripherally-acting reversible catechol-O-methyltransferase (COMT) inhibitor, for oral use as an adjunct to carbidopa/levodopa in adults with Parkinson’s disease (PD) who experience "off" episodes. It is the third COMT inhibitor to be approved for this indication; tolcapone (Tasmar, and generics) and entacapone (Comtan, and generics) were approved earlier. Opicapone has been available in Europe since 2016.

The goal of asthma treatment is to control symptoms, prevent exacerbations, and maintain normal lung function. Management of acute exacerbations of asthma in the emergency department is not discussed here.

View the table: Some Inhaled Drugs for Treatment of Asthma

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.

The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same 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.

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) propellants.

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 epinephrine auto-injectors provided a weight-appropriate dose for infants, so many physicians prescribed a 0.15-mg auto-injector off-label for this age group.2

The Auvi-Q device is about the length and width of a credit card and as thick as a cell phone. It has an automatic needle retraction system and a red safety guard at the needle-end of the device. Removal of the outer case initiates visual signals and an audio recording that provides step-by-step instructions and a 2-second countdown during the injection process.

Auvi-Q should be injected IM into the anterolateral aspect of the thigh (through clothing, if necessary). After treatment with epinephrine, the patient should be taken to the nearest emergency department; anaphylaxis symptoms recur in up to 15% of patients hours after resolution of the initial symptoms.3

The needle length in the new 0.1-mg auto-injector is shorter than in other epinephrine auto-injectors. Use of a shorter needle decreases the risk of striking bone when administering a dose to a small child, but may result in SC rather than IM injection.4,5 Higher levels of epinephrine are obtained with IM injection than with SC injection.6

Auvi-Q 0.1 mg is supplied in a carton containing two single-use auto-injectors and a training device without a needle. The outer case protects the epinephrine solution from light; exposure to excessive heat or cold should be avoided. The shelf-life of the epinephrine in the auto-injector is 18 months. All three strengths of Auvi-Q are priced the same.

1. Drugs for allergic disorders. Med Lett Drugs Ther 2017; 59:71.
2. SH Sicherer and FER Simons et al. Epinephrine for first-aid management of anaphylaxis. Pediatrics 2017; 139:e20164006.
3. S Lee et al. Update on biphasic anaphylaxis. Curr Opin Allergy Clin Immunol 2016; 16:346.
4. H Kim et al. Inadequacy of current pediatric epinephrine autoinjector needle length for use in infants and toddlers. Ann Allergy Asthma Immunol 2017; 118:719.
5. S Dreborg et al. Epinephrine auto-injector needle lengths: can both subcutaneous and periosteal/intraosseous injection be avoided? Ann Allergy Asthma Immunol 2018 Feb 27 (epub).
6. FE Simons et al. Epinephrine absorption in children with a history of anaphylaxis. J Allergy Clin Immunol 1998; 101:33.