Name: Anaphylm (dibutepinephrine) in Type I allergic reactions including anaphylaxis: Dosage forms and strengths
Published: 2026-09-21T21:39:21-04:00

Product information and disease description Product description Product information

Dosage forms and strengths

5 evidence topics · 6 sources

Film strength: 12 mg per film

“A single dose (12 mg) of DESF administered.” (opens the source at this quote in a new tab)

“Single dose of DESF (12 mg) administered after allergen challenge” (opens the source at this quote in a new tab)

Film size and weight

“Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration.” (opens the source at this quote in a new tab)

PharmFilm polymer matrix

“PharmFilm is comprised of proprietary polymer compositions that serve as film formers to APIs and excipients in place.” (opens the source at this quote in a new tab)
“PharmFilm, which is similar in thickness and size to a postage stamp, can be administered via buccal, sublingual or lingual oral delivery.” (opens the source at this quote in a new tab)

Primary packaging: pouch and carton

“The primary packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight.” (opens the source at this quote in a new tab)

“To resolve the FDA’s concerns, the Company has modified the pouch opening, instructions for use, pouch and carton labeling, and plans to rapidly conduct a new HF validation study with these modifications.” (opens the source at this quote in a new tab)

Storage and weather excursions

“It’s thinner than a credit card and requires no special storage, so patients can keep it in their phone case, wallet, or pocket” (opens the source at this quote in a new tab)

Material safety data sheet

No evidence found.