Atopic dermatitis, mild to moderate、Nonsegmental vitiligo.

Keratolytic Drugs

1.Absorption Plasma concentrations of ruxolitinib were quantifiable in all subjects. In adult subjects, the mean ± SD maximum plasma concentration (Cmax) and area under the concentration time curve from 0 to 12 hours post dose (AUC0–12) for ruxolitinib on Day 1 were 449 ± 883 nM and 3215 ± 6184 h*nM, respectively. There is no evidence of ruxolitinib accumulation after daily application for 28 days in subjects with atopic dermatitis. 2.Distribution Plasma protein binding is approximately 97%. 3.Elimination The mean terminal half-life of ruxolitinib following topical application of OPZELURA wasestimated in 9 subjects and is approximately 116 hours. 4.Metabolism Ruxolitinib is primarily metabolized by CYP3A4 and to a lesser extent by CYP2C9 in vitro. 5.Excretion Ruxolitinib and its metabolites are primarily excreted by urine (74%) and feces (22%). Less than 1% is excreted as unchanged drug.

There are no contraindications listed in the manufacturer's US labeling.

Adverse events were observed in animal reproduction studies following administration of oral ruxolitinib. Agents other than ruxolitinib are preferred for the topical treatment of atopic dermatitis and vitiligo in pregnant patients.

It is not known if ruxolitinib is present in breast milk following topical application. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for ~4 weeks after the last ruxolitinib dose.

In atopic dermatitis, the most common adverse reactions (incidence ? 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, rhinorrhea, upper respiratory tract infection, COVID-19, application site reactions, pyrexia, and white blood cell decreased. In nonsegmental vitiligo, the most common adverse reactions (incidence ? 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.

1.Atopic dermatitis, mild to moderate (alternative agent): Topical: Apply a thin layer to affected area(s) twice daily; application area should not exceed 20% BSA. Maximum dose: 60 g per week or 100 g per 2 weeks. Discontinue when signs/symptoms resolve. Reassess therapy if signs/symptoms have not resolved within 8 weeks. 2.Nonsegmental vitiligo: Topical: Apply a thin layer to affected area(s) twice daily; application area should not exceed 10% BSA. Maximum dose: 60 g per week or 100 g per 2 weeks. Reassess need for continued therapy if no meaningful improvement with re-pigmentation by 24 weeks.

Atopic dermatitis, mild to moderate: Children ?2 years and Adolescents: Apply a thin layer to affected area(s) twice daily; application area should not exceed 20% of total BSA. Children 2 to <12 years: Do not exceed 60 g every 2 weeks; Children ?12 years and Adolescents: 60 g every week or 100 g every 2 weeks. Discontinue when signs/symptoms resolved. If signs/symptoms not resolved within 8 weeks, reexamination by health care provider is recommended. Vitiligo, nonsegmental: Children ?12 years and Adolescents: Apply a thin layer to affected area(s) twice daily; application area should not exceed 10% of total BSA. Maximum dose: 60 g every week or 100 g every 2 weeks. It may require 24 weeks of treatment for a satisfactory response; if after 24 weeks of therapy, meaningful repigmentation has not been observed, reexamination by health care provider is recommended.

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely as limited systemic absorption is expected .

Ruxolitinib initiation is not recommended in patients with active hepatitis B or hepatitis C. There are no dosage adjustments provided in the manufacturer's labeling.

Store at 20oC to 25oC ; excursions permitted from 15oC to 30oC.