Adrenaline (epinephrine): new intranasal formulation approved for management of anaphylaxis
A new intranasal formulation of adrenaline (epinephrine) has been approved by the European Medicines Agency (EMA) for the emergency treatment of allergic reactions (anaphylaxis) caused by insect stings or bites, foods, medications, and other allergens, as well as idiopathic or exercise-induced anaphylaxis. The new formulation is approved for children with a body weight ≥30 kg and adults.[147]
This is the first formulation of adrenaline for the immediate management of anaphylaxis that is not delivered by injection.
Adrenaline 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 adrenaline achieves pharmacokinetic and pharmacodynamic profiles that are comparable to, if not better than, intramuscular adrenaline administered by a healthcare professional.[146] 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 anatomical 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.
Training videos and other digital educational materials will be available for healthcare professionals, patients, and carers in order to minimise inappropriate use of the device.
The intranasal formulation has also been approved by the US Food and Drug Administration (FDA), and may also be available in other countries.[148]
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.
Allergy is the most widespread chronic disorder in Europe, with approximately 150 million people affected in 2015.
Summary
Definition
History and exam
Key diagnostic factors
- acute onset
- airway swelling (angio-oedema)
- inspiratory stridor and hoarse voice
- shortness of breath
- wheezing, chest hyperinflation, and accessory muscle use
- cyanosis
- respiratory arrest
- pale, clammy skin
- hypotension
- increased pulse rate (tachycardia)
- bradycardia
- cardiac arrest
- confusion or disorientation
- urticaria (hives)
- erythema
- pruritus
- rhinitis
- bilateral conjunctivitis
Other diagnostic factors
- risk factors
- nausea, vomiting, diarrhoea, and incontinence
- abdominal cramps and pain
- agitation, anxiety, and a sense of impending doom (angor animi)
Risk factors
- adult age: food-, insect venom- and medicine-related
- <30 years old: food-associated, exercise-induced
- female sex
- atopy/asthma
- history of anaphylaxis
- exposure to a common sensitiser (e.g., latex)
Diagnostic investigations
1st investigations to order
- mast cell tryptase
- 12-lead ECG
- blood gases
- urea and electrolytes
Treatment algorithm
Contributors
Expert advisers
Alexander Alexiou, MB BS BSc DCH FRCEM Dip IMC RCSEd
Emergency Medicine Consultant
Barts Health NHS Trust
Physician Response Unit Consultant
London’s Air Ambulance
Royal London Hospital
London
UK
Disclosures
AA declares that he has no competing interests.
Thomas Palmer, BSc MBChB FRCEM
Emergency Medicine Consultant
Royal London Hospital
London
UK
Disclosures
TP declares that he has no competing interests.
Acknowledgements
BMJ Best Practice would like to gratefully acknowledge the previous team of expert contributors, whose work has been retained in parts of the content:
Doerthe Adriana Andreae MD
Assistant Professor
Pediatric Allergy and Immunology
Penn State Health Milton S. Hershey Medical Center
Hershey
PA
Michael Henning Andreae MD
Associate Professor
Department of Anesthesiology
Penn State Health Milton S. Hershey Medical Center
Hershey
PA
Disclosures
DAA is author of an UpToDate article on food allergy and a number of references cited in this topic. MHA is an author of a reference cited in this topic.
Peer reviewers
Robert Taylor, MBChB MRCP(UK) MRCP(London) DipMedTox DipTher PGDME FHEA FRCEM
Acute Hospital Sub Dean (Cornwall)
Honorary Clinical Senior Lecturer
Consultant Emergency Physician
The Knowledge Spa
Royal Cornwall Hospital
Truro
UK
Disclosures
RT declares that he has no competing interests.
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