Epinephrine (adrenaline): new intranasal formulation treatment approved for management of anaphylaxis
A new intranasal formulation of epinephrine (adrenaline) has been approved by the Food and Drug Administration (FDA) for the emergency treatment of type I allergic reactions, including anaphylaxis. The new formulation is approved for children with a body weight ≥30 kg and adults.[111]
This is the first formulation of epinephrine for the immediate management of anaphylaxis that is not delivered by injection.
Epinephrine is well absorbed from the nose and is quickly distributed into body tissues, so is an effective rapid treatment of anaphylaxis.
Studies show that self-administered intranasal epinephrine achieves pharmacokinetic and pharmacodynamic profiles that are comparable to, if not better than, intramuscular epinephrine administered by a healthcare professional.[112] There are no controlled clinical trials on efficacy in patients with severe allergic reactions as this would be unethical.
Absorption may be affected by underlying structural and anatomic nasal conditions (e.g., nasal polyps), and use of an injectable formulation should be considered in these patients.
The most common adverse effects were similar to those associated with injections (e.g., headache, nausea, throat irritation, dizziness), as well as nasal discomfort and a runny nose.
This represents an important development in the prehospital treatment of anaphylaxis, and could significantly broaden access to emergency treatment.
The intranasal formulation has also been approved by the European Medicines Agency (EMA) and may also be available in other countries.[113]
The new formulation is likely to be available for prescribing in the last quarter of 2024. It is not yet recommended in guidelines for the management of anaphylaxis.
Summary
Definition
History and exam
Key diagnostic factors
- acute onset
- urticaria
- angioedema
- flushing
- dyspnea
- wheezing
- rhinitis
Other diagnostic factors
- allergen ingestion
- insect stings or bites
- pruritus
- inspiratory stridor and hoarse voice
- bilateral conjunctivitis
- nausea and vomiting
- abdominal cramping or pain
- agitation/anxiety
- confusion/disorientation
- tachycardia
- dizziness
- syncope
- sense of impending doom (angor animi)
- recent exercise
- hot or cold exposure
- hypotension
- bradycardia
- cardiac arrest
- diarrhea
- visual disturbances
- tremor
- seizures
Risk factors
- adult age: food-, insect venom-, and medication-related
- <30 years old: food-associated, exercise-induced
- female sex
- atopy/asthma
- history of anaphylaxis
- exposure to a common sensitizer (e.g., latex)
Diagnostic tests
1st tests to order
- serum tryptase level
Tests to consider
- in vitro IgE testing
- skin test
- challenge test
Emerging tests
- basophil activation test
Treatment algorithm
all patients: acute onset
patients with identified allergen
Contributors
Expert advisers
Nathan A. Blaseg, MD
Resident Physician
Pediatrics
University of Utah
Salt Lake City
UT
Disclosures
NAB declares that he has no competing interests.
Doerthe A. Andreae, MD
Associate Professor
Allergy/Immunology
Department of Dermatology
University of Utah
Salt Lake City
UT
Disclosures
DAA is author of an UpToDate article on food allergy, for which she receives royalties. DAA is an author of a number of references cited in this topic.
Acknowledgements
Dr Nathan A. Blaseg and Dr Doerthe A. Andreae would like to gratefully acknowledge Dr Michael Henning Andreae and Dr Andrea Vereda, previous contributors to this topic.
Disclosures
AV declares that she is currently employed by Aimmune Therapeutics. AV wrote the main content of this topic before taking up this appointment. MHA is an author of a reference cited in this topic.
Peer reviewers
Frank J. Domino, MD
Associate Professor
Family Medicine and Community Health
University of Massachusetts Medical School
Worcester
MA
Disclosures
FJD declares that he has no competing interests.
Wayne Shreffler, MD, PhD
Assistant Professor of Pediatrics
Mount Sinai School of Medicine
New York
NY
Disclosures
WS declares that he has no competing interests.
Lawrence Youlten, FRCP (Edin), PhD
Visiting Consultant in Allergy
Addenbrooke’s Hospital NHS Trust
Cambridge
UK
Disclosures
LY declares that he has no competing interests.
Grant Hayman, MBChB, MRCP, DTM and H, MSc, FRCPath
Consultant Immunologist
Department of Immunology
Epsom & St Helier University Hospitals NHS Trust
Carshalton
Surrey
UK
Disclosures
GH declares that he has no competing interests.
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