Adquey (difamilast)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

The most common adverse reaction occurring in >=1% of subjects is nasopharyngitis.

There are no severe adverse reactions for this drug.

More Frequent

• Pharyngitis

Rare or Very Rare

• Application site infection
• Application site skin reactions
• Contact dermatitis
• Molluscum contagiosum infection

No enhanced messaging available.

The safety and effectiveness of difamilast for the topical treatment of mild to moderate atopic dermatitis have been established in pediatric patients 2 years of age and older. Use of difamilast in this age group is supported by data from five vehicle-controlled trials, which included 236 subjects 2 to less than 17 years of age, of whom 119 received difamilast and 117 received vehicle.

The safety and effectiveness of difamilast have not been established in pediatric patients younger than 2 years of age.

The available data on the use of topical difamilast during pregnancy are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

In animal reproduction studies, difamilast administered subcutaneously to pregnant rats and rabbits during the period of organogenesis produced no fetal structural abnormalities at doses up to 30 and 3 times the maximum recommended human dose (MRHD), respectively. Difamilast induced increased post-implantation loss, decreased fetal weight, retarded ossification and increased visceral abnormalities in rats at subcutaneous dose 263 times the MRHD. Difamilast induced increased skeletal variations in rabbits at subcutaneous doses 14 times the MRHD. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

There are no data on the presence of difamilast or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.

Difamilast and/or its metabolites are excreted into the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for difamilast and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.

To minimize potential infant exposure, advise breastfeeding women not to apply difamilast directly to the nipple or areola. If applied to the patient's chest, avoid exposure via direct contact with the infant's skin.

In clinical trials of difamilast in subjects with mild to moderate atopic dermatitis, 2 subjects were 65 years of age or older, and none were 75 years of age and older. Clinical trials of difamilast did not include sufficient numbers of subjects 65 years of age and over to determine whether they respond differently from younger adult subjects.