Adquey (difamilast) is filed as Phosphodiesterase 4 Inhibitor [EPC]. The sections below restate public label fields stored for this profile.
1 INDICATIONS & USAGE ADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. ADQUEY is a phosphodiesterase 4 inhibitor indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. (1)
12.1 Mechanism of Action Difamilast is an inhibitor of phosphodiesterase-4 (PDE-4). Difamilast’s inhibition of PDE-4 (a major cyclic adenosine monophosphate (AMP)-metabolizing enzyme) activity leads to accumulation of intracellular cyclic AMP and decreased productions of various cytokines and chemokines. However, the specific mechanism(s) by which difamilast exerts its therapeutic action is not well defined.
4 CONTRAINDICATIONS None. None. (4)
Nasopharyngitis (6%)
6 ADVERSE REACTIONS The most common adverse reaction occurring in ≥1% of subjects is nasopharyngitis. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ADQUEY was assessed in two double-blind, vehicle-controlled clinical trials (Trial 2 and Trial 3) that enrolled 532 adult and pediatric subjects 2 years of age and older in Japan with mild to moderate atopic dermatitis (AD). Subjects applied ADQUEY or vehicle ointment topically twice daily for 4 weeks [ see Clinical Studies (14) ]. Adverse reactions reported by ≥1% of ADQUEY-treated subjects and more frequently than in subjects receiving vehicle are listed in Table 1. Table 1: Adverse Reactions Occurring in ≥1% of Adult and Pediatric Subjects 2 Years of Age and Older Treated with ADQUEY for Mild to Moderate Atopic Dermatitis (and Greater than Vehicle) through Week 4 in Trials 2 and 3 Adverse Reaction ADQUEY (N=267) n (%) Vehicle (N=265) n (%) Nasopharyngitis 16(6) 10(4) Less common (<1%) adverse reactions in subjects treated with ADQUEY in Trials 2 and 3 included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum. In Trial 1, a vehicle-controlled dose ranging trial, 43 subjects 10 years of age and older in the United States, Australia, and Poland received ADQUEY topically twice daily for 8 weeks and the safety profile was consistent with Trials 2 and 3. In two additional vehicle-controlled dose ranging trials (Trial 4 and Trial 5), 92 subjects 2 years of age and older in Japan received ADQUEY topically twice daily for 4 weeks (Trial 4) and twice daily for 8 weeks (Trial 5) and the safety profile was consistent with Trials 2 and 3. In open-label trials of both Japanese and United States (US) subjects, 857 adult and pediatric subjects continued twice-daily treatment with ADQUEY for up to 52 weeks. The following application site adverse reactions occurred that led to drug discontinuation: pain, pruritus, vesicles, blistering, erythema, burning and contact dermatitis. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ADQUEY. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site condition : application site swelling.
2 DOSAGE & ADMINISTRATION ADQUEY is for topical use only and not for ophthalmic, oral, or intravaginal use. Apply a thin layer of ADQUEY twice daily to affected areas and rub in completely. Wash hands after application. Avoid areas of the skin that are infected when applying ADQUEY. For topical use only. Not for ophthalmic, oral, or intravaginal use. (2) Apply a thin layer of ADQUEY twice daily to affected areas and rub in completely. (2)
17 PATIENT COUNSELING INFORMATION Advise patients or caregivers to read the FDA-approved patient labeling (Patient Information). Administration Advise patients or caregivers that ADQUEY is for topical use only and is not for ophthalmic, oral, or intravaginal use [see Dosage and Administration (2) ]. Lactation Advise breastfeeding women not to apply ADQUEY directly to the nipple or areola to minimize potential infant exposure. Instruct patients to avoid inadvertent contact of treated areas with the infant’s skin [see Use in Specific Populations (8.2) ]. (Made in Canada) Manufactured for: Acrotech Biopharma Inc East Windsor, NJ 08520 USA PATIENT INFORMATION ADQUEY TM (ahd kway) (difamilast) ointment, for topical use Important information: ADQUEY is for use on the skin (topical use) only. Do not use ADQUEY near or in your eyes, mouth, or vagina. What is ADQUEY? ADQUEY is a prescription medicine used on the skin (topical) to treat adults and children 2 years of age and older with mild to moderate atopic dermatitis. It is not known if ADQUEY is safe and effective in children younger than 2 years of age. Before using ADQUEY, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if ADQUEY will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if ADQUEY passes into your breast milk or if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ADQUEY. Breastfeeding women using ADQUEY should not apply ADQUEY directly to the nipple or areola to avoid contact with your baby. Avoid contact between your baby and any skin areas treated with ADQUEY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use ADQUEY? Use ADQUEY exactly as your healthcare provider tells you to use it. Apply a thin layer of ADQUEY to the affected areas 2 times a day. Rub the ointment in completely until you no longer see it on your skin. Avoid applying ADQUEY to areas of the skin that are red, warm, swollen or painful. Wash your hands after applying ADQUEY. If someone else applies ADQUEY for you, they should wash their hands after applying it. What are the possible side effects of ADQUEY? The most common side effects of ADQUEY include: pain or swelling in the nose and throat (nasopharyngitis). These are not all of the possible side effects of ADQUEY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store ADQUEY? Store ADQUEY at room temperature between 68°F to 77°F (20°C to 25°C). Store ADQUEY away from direct sunlight, heat and moisture. Keep ADQUEY tube tightly closed after each use. Keep ADQUEY and all medicines out of the reach of children. General information about the safe and effective use of ADQUEY. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ADQUEY for a condition for which it was not prescribed. Do not give ADQUEY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about ADQUEY that is written for health professionals. What are the ingredients in ADQUEY? Active ingredient: difamilast Inactive ingredients: mineral oil, paraffin, propylene carbonate, white petrolatum, and white wax. (Made in Canada) Manufactured for:Acrotech Biopharma Inc, East Windsor, NJ 08520 USA For more information, call 1-888-292-9617 or go to www.ADQUEY.com. This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 02/2026
According to its FDA label, Adquey (difamilast) is approved for: 1 INDICATIONS & USAGE ADQUEY is indicated for the topical treatment of adults and pediatric patients 2 years of age and older with mild to moderate atopic dermatitis. ADQUEY is a phosphodiesterase 4 inhibitor indicated for the topical treatment of adults and pediatric patients 2… For medical advice, please talk to your prescriber or pharmacist.
Adquey (difamilast) belongs to the Phosphodiesterase 4 Inhibitor [EPC] class of medications.
The FDA label lists Adquey (difamilast) as: 3 DOSAGE FORMS & STRENGTHS Ointment: 1% (10 mg of difamilast per gram) of white to off-white ointment. Ointment: 1%. (3); topical route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Adquey. Availability changes as patents expire.
Our ingest of the FDA label for Adquey (difamilast) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Adquey (difamilast) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Adquey (difamilast) as 2026-02-12.
The FDA label lists Acrotech Biopharma Inc as a labeler/manufacturer of Adquey (difamilast). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage and Handling Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F). [see USP Controlled Room Temperature]. Store away from direct sunlight, heat, and moisture. Keep tube tightly closed." Follow the packaging insert for the authoritative guidance.
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