OPZELURA Cream Ref.[115069] Active ingredients: Ruxolitinib

Opzelura should be initiated and supervised by physicians with experience in the diagnosis and treatment of non-segmental vitiligo.

Posology

Adults

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.

Special populations

Hepatic impairment

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.

Renal 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.

Elderly

A limited number of patients aged 65 years and above have been enrolled in the clinical studies with Opzelura in vitiligo 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.

Paediatric population

For adolescents (12-17 years) the posology is the same as for adults.

The safety and efficacy of ruxolitinib cream in children below 12 years of age have not been established. No data are available.

Method of administration

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 puncture cap.

Tube of 100 g. One tube per carton.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.