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Anaphylm (dibutepinephrine)

Type I allergic reactions including anaphylaxis

Also known as AQST-109
Regulatory submission
NDA resubmitted September 2026
Launch
Not announced
Last updated
121 sources

Product information and disease descriptionPlace of product in therapyDisease description

Definition and etiology

11 evidence topics · 6 sources

Consensus definition of anaphylaxis

“Anaphylaxis is a serious allergic (hypersensitivity) reaction that can progress rapidly and may cause death. It may involve the skin/mucosa (includes lip/tongue), respiratory (lungs, breathing), cardiovascular (heart, blood pressure), and/or gastrointestinal (stomach/gut) systems. Life-threatening anaphylaxis is characterized by respiratory and/or cardiovascular involvement and may occur without skin/mucosa involvement.” (opens the source at this quote in a new tab)

Anaphylaxis as a type I, IgE-mediated hypersensitivity reaction

“Anaphylaxis is classically described as a type 1 hypersensitivity reaction driven by IgE-mediated release of histamine and other mediators from effector cells (such as mast cells) after allergen exposure. Non-IgE-mediated anaphylaxis is also well described, particularly to some drugs and certain types of exercise-induced anaphylaxis; symptoms/signs are indistinguishable from IgE-mediated anaphylaxis.” (opens the source at this quote in a new tab)

Type I allergic pathway as the primary mechanism of anaphylaxis

“The primary mechanism behind most cases of human anaphylaxis is mediated by classic type-I allergic reactions pathway involving IgE and mast cells/basophils.” (opens the source at this quote in a new tab)

World Allergy Organization definition of anaphylaxis and severe anaphylaxis

“Anaphylaxis is a serious systemic hypersensitivity reaction that is usually rapid in onset and may cause death. Severe anaphylaxis is characterized by potentially life-threatening compromise in airway, breathing and/or the circulation, and may occur without typical skin features or circulatory shock being present.” (opens the source at this quote in a new tab)

Immunologic and non-immunologic mechanisms of hypersensitivity

“In the immunologic IgE-mediated mechanism, cross-linking of cell surface high-affinity IgE receptors (FcɛRI) initiated by the binding of IgE with antigens causes degranulation of effector cells.” (opens the source at this quote in a new tab)

Most frequent elicitor groups worldwide

“The most frequent elicitor groups worldwide are food, insect venom, and drugs” (opens the source at this quote in a new tab)

“Elicitor groups other than the above mentioned are natural rubber latex, seminal fluid, radiocontrast media, medical dyes, and a variety of substances which are administered to patients in the perioperative setting (eg, suxamethonium, rocuronium, thiopental, propofol, opioids, protamine, chlorhexidine, plasma expanders)” (opens the source at this quote in a new tab)

Food and drug elicitors by age and region

“The most frequent elicitors of food-induced anaphylaxis in children are hen's egg (in infants and pre-school children), cow's milk, wheat, and peanut.” (opens the source at this quote in a new tab)

“Peanut and tree nuts are dominating elicitors of food-induced anaphylaxis in adults in North America and Australia; whereas, shellfish is a frequent elicitor of food-induced anaphylaxis in Asia.” (opens the source at this quote in a new tab)

“Drug-induced anaphylaxis is most frequently triggered by antibiotics and nonsteroidal anti-inflammatory drugs (NSAIDs), again with age and geographical variations worldwide.” (opens the source at this quote in a new tab)

Proportion of anaphylaxis attributed to food, stings, and medications

“The most common causes for anaphylaxis across all age groups include food (33%), stings (19%) and medications (14%)” (opens the source at this quote in a new tab)

“In children, food allergies account for most cases of anaphylaxis” (opens the source at this quote in a new tab)

Triggers of anaphylaxis emergency department visits in older versus younger United States adults

“Compared to younger adults, visits among older adults were more likely to involve anaphylaxis from medications (34.0% vs 21.3%; odds ratio (OR) 1.85, 95% confidence interval (CI) 1.34, 2.55) and intravenous (IV) contrast (13.2% vs 5.6%; OR 2.50, 95% CI 1.55, 4.04).” (opens the source at this quote in a new tab)

Idiopathic anaphylaxis as a proportion of cases

“Anaphylaxis is classified as idiopathic when no trigger can be identified and currently represents between 6.5 and 35.0% of cases, depending on the studies.” (opens the source at this quote in a new tab)

Cofactors that increase the severity of a reaction

“Exogenous factors, which may increase the risk of an anaphylaxis reaction, include physical exercise, infections, psychological burden, sleep deprivation, alcohol intake, and medications.” (opens the source at this quote in a new tab)