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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 descriptionProduct descriptionProduct information

Contraindications/Warnings/Precautions/Adverse effects

12 evidence topics · 10 sources

Warnings and precautions
Epinephrine class: absence of contraindications in approved labeling

“None.” (opens the source at this quote in a new tab)

“None.” (opens the source at this quote in a new tab)

Epinephrine class: common systemic adverse reactions

“Adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.” (opens the source at this quote in a new tab)

Epinephrine class: postapproval adverse reactions

“Cardiovascular: angina, arrhythmias (including fatal ventricular fibrillation), cerebral hemorrhage, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy” (opens the source at this quote in a new tab)

“Metabolism and Nutrition Disorders: transient hyperglycemia, sweating” (opens the source at this quote in a new tab)

“Neurological: disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling, weakness” (opens the source at this quote in a new tab)

“Psychiatric: anxiety, apprehensiveness, restlessness” (opens the source at this quote in a new tab)

“Respiratory: respiratory difficulties” (opens the source at this quote in a new tab)

Epinephrine class: coexisting conditions that increase the risk of adverse reactions

“Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris, as well as produce ventricular arrhythmias” (opens the source at this quote in a new tab)

“Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson's disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.” (opens the source at this quote in a new tab)

“Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation.” (opens the source at this quote in a new tab)

Anaphylm clinical program: overall tolerability

“These studies showed that Anaphylm was generally well-tolerated and had a safety profile similar to that of epinephrine.” (opens the source at this quote in a new tab)

Phase 3 pivotal study: serious adverse events

“No serious adverse events were reported.” (opens the source at this quote in a new tab)

Oral allergy syndrome study: treatment-emergent adverse events

“Almost all patients experienced a related mild treatment-emergent adverse event; 4 were considered moderate in severity, and no new safety signals were identified compared with previous studies.” (opens the source at this quote in a new tab)

Oral allergy syndrome study: severity and resolution of adverse events

“In addition, Anaphylm was safe and well-tolerated with all adverse events categorized as mild or moderate and resolving without medical intervention.” (opens the source at this quote in a new tab)

Phase 1 study: local administration site effects

“All formulations and dosage strengths evaluated in this study were well tolerated . No serious AE’s were observed and local administration site AE’s were mild and self - resolving” (opens the source at this quote in a new tab)

Confirmatory pharmacokinetic study: tolerability and film retention

“From a tolerability perspective, there were no participants in the HF study and no subjects in the PK study who prematurely removed the film. In the PK study there were no serious adverse events, no serious events, and no events that led to study drug discontinuation.” (opens the source at this quote in a new tab)

Reported frequency of oral and sublingual swelling in the oral allergy syndrome study

“only 6% of subjects reported tongue swelling of any severity, and 2% of subjects reported sublingual swelling of any severity)” (opens the source at this quote in a new tab)

Pediatric study: serious adverse events

“Importantly, Anaphylm was shown to be safe and well-tolerated with no serious adverse events (SAEs) reported.” (opens the source at this quote in a new tab)

Proposed labeling published by a regulator

Not applicable.