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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

Diagnosis

14 evidence topics · 8 sources

Anaphylaxis as a clinical diagnosis without a confirmatory test

“Anaphylaxis is a clinical diagnosis that lacks a definitive test.” (opens the source at this quote in a new tab)

“There is no gold-standard diagnostic test for anaphylaxis. Tryptase may be helpful to obtain, depending on the clinical scenario, for later supporting the diagnosis. Until better diagnostic tests are developed, anaphylaxis remains a clinical diagnosis.” (opens the source at this quote in a new tab)

NIAID and FAAN clinical criteria: structure and organ system requirements

“In practice, clinicians rely on clinical criteria to assess the likelihood of anaphylaxis; however, these criteria are not perfectly sensitive or specific.” (opens the source at this quote in a new tab)

“The first applies to reactions without a likely or known trigger, the second to patients with likely allergen exposure, and the third to those with known allergen exposures. The first and second criteria require multisystem involvement, whereas the third accounts for the uncommon situation where a patient develops isolated hypotension after known allergen exposure.” (opens the source at this quote in a new tab)

Test characteristics of the NIAID and FAAN criteria

“In the retrospective ED-based study (n =214), the test characteristics of the criteria were: sensitivity, 96.7% (95% CI, 88.8% to 99.1%); specificity, 82.4% (95% CI, 75.5% to 87.6%); positive predictive value, 68.6% (95% CI, 58.2% to 77.4%); negative predictive value, 98.4% (95% CI, 94.5% to 99.6%); positive likelihood ratio, 5.48; and negative likelihood ratio, 0.04.” (opens the source at this quote in a new tab)

“In contrast, for the prospective ED study (n = 174), the test characteristics were: sensitivity, 95.1% (85.4%–98.7%); specificity, 70.8% (61.4%–78.8%); positive predictive value, 63.7% (52.9%–73.4%); negative predictive value, 96.4% (89.1%–99.1%); positive likelihood ratio, 3.26; and negative likelihood ratio, 0.07.” (opens the source at this quote in a new tab)

Misapplication of the diagnostic criteria in clinical care

“The NIAID/FAAN criteria have been misused in clinical care as strict diagnostic criteria, leading clinicians to believe they can only administer epinephrine if a patient meets these criteria. In reality, they are meant to support clinical decision-making, and the decision to give epinephrine should be made independently of whether the criteria are met.” (opens the source at this quote in a new tab)

Amended World Allergy Organization criteria

“Furthermore, the WAO Anaphylaxis Committee has proposed to amend the current NIAID/FAAN criteria, as shown in Table 2. The aim is to simplify the existing criteria, by combining the first 2 NIAID/FAAN criteria and modifying the third” (opens the source at this quote in a new tab)

“Typical skin symptoms AND significant symptoms from at least 1 other organ system; OR” (opens the source at this quote in a new tab)

“Exposure to a known or probable allergen for that patient, with respiratory and/or cardiovascular compromise.” (opens the source at this quote in a new tab)

GA2LEN consensus criteria and clinical support tool

“The clinical support tool incorporates a) new clinical criteria to help determine the likelihood that patients are having anaphylaxis, b) intramuscular epinephrine indications and dosing, and c) common findings from the anaphylaxis organ systems.” (opens the source at this quote in a new tab)

“We propose that the anaphylaxis definition and clinical support tool should replace prior definitions and clinical criteria.” (opens the source at this quote in a new tab)

Serum tryptase kinetics and interpretation

“During acute anaphylaxis, serum tryptase levels are increased from 15 min to 3 h or even longer, after the onset; levels peak between 1 and 2 h after the onset with 36–40% remaining <11.4 μg/L.” (opens the source at this quote in a new tab)

“Although elevated levels support a diagnosis of anaphylaxis, normal levels do not exclude anaphylaxis having occurred” (opens the source at this quote in a new tab)

Serum tryptase threshold after suspected food-induced anaphylaxis

“The results of a serum tryptase test obtained 90 minutes to 4 hours after a suspected food-induced anaphylaxis event that show an increase by at least 1.2 times the patient’s baseline value plus 2 ng/mL is highly suggestive of mast cell degranulation and can assist allergy specialists in confirming the diagnosis.” (opens the source at this quote in a new tab)

“in which serum tryptase levels were measured before and during an oral food challenge to induce anaphylaxis, serum tryptase levels increased above baseline in 100 of 160 cases and increased above the upper limit of normal (11.4 ng/mL) in 4 out of 160 cases.” (opens the source at this quote in a new tab)

Specific IgE serology and skin prick testing

“Allergic sensitization to suspected foods can be assessed by measuring food-specific serum IgE levels or performing skin prick testing.” (opens the source at this quote in a new tab)

“Given imprecise, variable predictive values, both skin prick testing and allergen-specific IgE, whether for single foods or in multifood panels, have limited utility as screening tools for food-protein allergies when interpreted without a history of allergic symptoms to a specific suspected food.” (opens the source at this quote in a new tab)

Oral food challenge as the reference standard

“The reference standard for the diagnosis of IgE-mediated food allergy is the oral food challenge.” (opens the source at this quote in a new tab)

“In practice, oral food challenges require significant time and clinical resources and inherently incur the risk of inducing allergic reactions.” (opens the source at this quote in a new tab)

Under-recognition and under-treatment of anaphylaxis

“Despite many advances in understanding etiology, mechanisms and management, anaphylaxis remains underdiagnosed and undertreated” (opens the source at this quote in a new tab)

Recognition difficulty in infants and young children

“Likewise, recognition of anaphylaxis may be especially challenging for noncommunicative patients including infants and young children who may present with nonspecific symptoms that overlap with normal infant behavior (eg, fussiness, drooling, spitting up).” (opens the source at this quote in a new tab)

Differential diagnosis

“Differential diagnosis of anaphylaxis includes acute asthma, localized angioedema, syncope, and anxiety/panic attacks, among others” (opens the source at this quote in a new tab)

Practice parameter recommendations on applying the diagnostic criteria

“We suggest that meeting diagnostic criteria for anaphylaxis is not required before the use of epinephrine.” (opens the source at this quote in a new tab)

“We suggest that neither the clinical decision to administer epinephrine nor the clinical response to epinephrine be used as a surrogate marker to establish a diagnosis of anaphylaxis.” (opens the source at this quote in a new tab)