Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Incyte Biosciences Distribution B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Netherlands
Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.
Opzelura is indicated for the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate.
Opzelura should be initiated and supervised by physicians with experience in the diagnosis and treatment of conditions for which ruxolitinib cream is indicated.
The recommended dose is a thin layer of cream applied twice daily to the depigmented skin areas up to a maximum of 10% of body surface area (BSA), with a minimum of 8 hours between two applications of ruxolitinib cream. 10% BSA represents an area as large as 10 times the palm of one hand with the 5 fingers. Ruxolitinib cream should be used at the smallest skin area necessary.
No more than two tubes of 100 grams a month should be used.
Satisfactory repigmentation may require treatment beyond 24 weeks. If there is less than 25% repigmentation in treated areas at week 52, treatment discontinuation should be considered.
Once satisfactory repigmentation is achieved, treatment in those areas can be stopped. If depigmentation recurs after treatment discontinuation, therapy can be reinitiated on the affected areas.
There is no need to consider tapering therapy.
A thin layer of cream should be applied twice daily to the affected skin area up to a maximum of 20% of BSA, until clearance of the lesions. It is recommended to apply the cream at regular intervals, with a minimum of 8 hours between two applications of ruxolitinib cream. Ruxolitinib cream should be used at the smallest skin area necessary.
No more than 4 tubes of 100 grams a month should be used.
In the event of recurrence of the signs and symptoms, twice daily treatment of the affected areas should be re-initiated as needed.
Treatment should be discontinued if no improvement is seen after 8 weeks of twice daily treatment.
No studies with ruxolitinib cream have been performed in patients with hepatic impairment. However, due to limited systemic exposure, dose adjustment is not necessary in patients with hepatic impairment.
No studies with ruxolitinib cream have been performed in patients with renal impairment. However, due to limited systemic exposure, dose adjustment is not necessary in patients with renal impairment. As a precautionary measure, ruxolitinib cream should not be used by patients with end stage renal disease, due to lack of data regarding the safety.
A limited number of patients aged 65 years and above have been enrolled in the clinical studies with Opzelura in vitiligo and atopic dermatitis to determine whether they respond differently from younger subjects (see section 5.1). No dose adjustment is required in patients aged 65 years and above.
Vitiligo:
For adolescents (12 to 17 years) with vitiligo the posology is the same as for adults.
The safety and efficacy of ruxolitinib cream in children below 12 years of age with vitiligo have not been established. No data are available.
Atopic dermatitis:
There is no relevant use of ruxolitinib cream in the paediatric population from birth to less than 3 months of age. The safety and efficacy of ruxolitinib cream in children aged 3 months to 17 years old have not yet been established. Currently available data are described in section 5.1 but no recommendation on a posology can be made.
The cream is for cutaneous use only.
Avoid washing treated skin for at least 2 hours after application of ruxolitinib cream.
The cream should not be applied to the lips to avoid its ingestion.
Patients should be instructed to wash their hands after applying the cream, unless it is their hands that are being treated. If someone else applies the cream to the patient, they should wash their hands after application.
Overdose following cutaneous administration is unlikely. If too much of the cream has been applied, the excess can be wiped off.
In cases of accidental ophthalmic, oral mucosa, or intravaginal exposure, the cream should be thoroughly wiped off and/or rinsed with water (see sections 4.2 and 4.4).
21 months.
After first opening: 6 months.
Do not store above 30ºC.
Laminate tube with an inner lining of low-density and high-density polyethylene with a polypropylene cap, or aluminium tube with internal lacquer coating with a polypropylene (100 g tube) or high-density polyethylene (5 g tube) puncture cap.
Tubes of 5 g and 100 g. One tube per carton.
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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