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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 therapyApproaches to treatmentCurrent treatment options and standard of care

Intramuscular epinephrine auto-injectors

18 evidence topics · 5 sources

Guideline position: intramuscular epinephrine is first-line therapy

“Epinephrine is universally recommended as the first-line treatment for anaphylaxis.” (opens the source at this quote in a new tab)

Guideline position: World Allergy Organization anaphylaxis guidance

“Intramuscular epinephrine (adrenaline) continues to be the first-line treatment for anaphylaxis. Nevertheless, its use remains suboptimal.” (opens the source at this quote in a new tab)

“The dose recommended for use by healthcare professionals is 0.01 mg/kg of body weight, to a maximum total dose of 0.5 mg, given by the intramuscular route” (opens the source at this quote in a new tab)

“Dosing should be repeated every 5–15 min if symptoms are refractory to treatment.” (opens the source at this quote in a new tab)

Recommendation to prescribe and carry self-injectable epinephrine

“We recommend clinicians counsel patients at high risk of anaphylaxis to always carry self-injectable epinephrine and teach patients proper indications and use.” (opens the source at this quote in a new tab)

“We suggest clinicians routinely prescribe EAIs to patients at higher risk of anaphylaxis. When deciding whether to prescribe EAIs to lower risk patients, we suggest that clinicians engage in a shared decision-making process that considers the patients’ risk factors, values, and preferences.” (opens the source at this quote in a new tab)

Timing of administration relative to symptom onset

“We suggest that clinicians counsel patients and caregivers to give epinephrine at the first sign of suspected anaphylaxis.” (opens the source at this quote in a new tab)

“There is no evidence that preemptive use of epinephrine in asymptomatic patients prevents anaphylaxis.” (opens the source at this quote in a new tab)

Products available in the United States and device selection

“Multiple brands of EAIs are available in the United States, including the following: Auvi-Q (Kaleo), EpiPen/EpiPen Jr. (Mylan), and generic versions of EpiPen/EpiPen Jr. (Viatris, Teva) and Adrenaclick (Amneal).” (opens the source at this quote in a new tab)

“When deciding which EAI to prescribe, we suggest that clinicians consider dosage, needle length, affordability, access, and patient treatment preferences.” (opens the source at this quote in a new tab)

Approved auto-injector dosing by body weight: EpiPen and EpiPen Jr

“EpiPen and EpiPen Jr are indicated for the emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients who weigh 15 kg or greater.” (opens the source at this quote in a new tab)

“In the absence of clinical improvement or if symptoms worsen after the initial treatment, a second dose of EpiPen or EpiPen Jr may be administered with a second auto-injector starting 5 minutes after the first dose.” (opens the source at this quote in a new tab)

“It is recommended that patients are prescribed and have immediate access to two EpiPen or EpiPen Jr devices at all times.” (opens the source at this quote in a new tab)

Auto-injector dose by weight band
Patient weightQuoted dosage
30 kg or greater“EpiPen 0.3 mg”
15 kg to less than 30 kg“EpiPen Jr 0.15 mg”
Auto-injector dosing for infants and toddlers under 15 kg

“We suggest clinicians prescribe either the 0.1 mg or the 0.15 mg EAI dose for infants/toddlers weighing less than 15 kg.” (opens the source at this quote in a new tab)

Safety of intramuscular epinephrine delivered by auto-injector

“Serious adverse reactions to intramuscular epinephrine are very rare and should not pose a barrier to the prescription or early administration of EAIs when indicated.” (opens the source at this quote in a new tab)

“A 2018 computer simulation study found that the serious adverse event rate for EAI administration was only 0.73%.” (opens the source at this quote in a new tab)

Storage conditions for auto-injectors

“Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)” (opens the source at this quote in a new tab)

“Protect from light. Epinephrine is light sensitive and should be stored in the outer carton provided to protect it from light.” (opens the source at this quote in a new tab)

Underuse of epinephrine in the community

“Only 21% of children and 7% of adults experiencing anaphylaxis in community settings receive epinephrine prior to hospital arrival” (opens the source at this quote in a new tab)

“Pre-hospital epinephrine is consistently associated with reduced biphasic risk and shorter emergency department stays, yet underuse persists in up to two-thirds of community events” (opens the source at this quote in a new tab)

“Autoinjector cost, limited public access, and training disparities fuel preventable deaths, particularly in low-resource settings” (opens the source at this quote in a new tab)

Carriage, fill, and refill of prescribed devices

“Even when clinicians prescribe EAIs, patients do not always adhere to their treatment plans, with researchers reporting suboptimal rates of EAI prescription fills and refills, carriage, and use.” (opens the source at this quote in a new tab)

Reported barriers to auto-injector use

“Even when prescribed, the rates of AAI use remain low, ranging from 16% to 32%.” (opens the source at this quote in a new tab)

“Common barriers to AAI use include patient reluctance due to the device’s design, fear of needles, pain at the injection site, worry about social embarrassment, and concerns about accidental needle injuries.” (opens the source at this quote in a new tab)

Needle phobia as a factor against home management

“Hesitance about the intramuscular injection (needle phobia)” (opens the source at this quote in a new tab)

Injection injuries with auto-injectors

“Other potential adverse events after an EAI administration include lacerations and embedded needles. These injuries may result when a patient or caregiver moves during administration, the device discharges off center due to malfunction, or the needle bends after hitting a bone.” (opens the source at this quote in a new tab)

“More research is needed to evaluate strategies to reduce the risk of EAI-related laceration and other injuries.” (opens the source at this quote in a new tab)

Needle length and delivery depth

“Needle length may be an important consideration in young infants with low body mass, in women, and in adults with high body mass index (>25).” (opens the source at this quote in a new tab)

“Ultrasound imaging measurements suggest that among adults, the risk of subcutaneous injection is highest in obese women.” (opens the source at this quote in a new tab)

Cost and packaging constraints in the United States

“A 2018 survey of parents of children with food allergy in the United States found that 97% felt financially burdened by the cost of EAIs.” (opens the source at this quote in a new tab)

“In the United States, the average wholesale price of 2 EpiPens increased dramatically from $113.27 in 2007 to $730.33 in 2016.” (opens the source at this quote in a new tab)

“In the United States, EAIs are sold only in packages of 2; the cost might be reduced, and access improved, if they were available in single units.” (opens the source at this quote in a new tab)

Availability and affordability of auto-injectors internationally

“The limited availability of epinephrine auto-injectors remains a major problem in many countries, as well as their affordability for some patients.” (opens the source at this quote in a new tab)