Opzelura

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.

3 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.

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.

8%). Tabulated list of adverse reactions Adverse reactions are ranked under headings of frequency, with the most frequent first, using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).

Table 1:

Adverse reactions System Organ Class Frequency Adverse Reaction General disorders and administration site conditions Common Application site acne Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 6

2). In cases of accidental exposure in the eyes or mucous membranes, the cream should be thoroughly wiped off and/or rinsed with water. 4 Non-melanoma skin cancer Non-melanoma skin cancers (NMSCs), predominantly basal cell carcinomas, have been reported in patients treated with topical ruxolitinib.

Most of these patients had risk factors, such as prior phototherapy or prior NMSC. A causal relationship to topical ruxolitinib has not been established. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

Excipients with known effect Propylene glycol This medicinal product contains 150 mg propylene glycol (E1520) in each gram of cream which may cause skin irritation. g. contact dermatitis). Parahydroxybenzoates This medicinal product contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

g. contact dermatitis), or irritation to the eyes and mucous membranes. Polysorbate 20 This medicinal product contains polysorbate 20 (E432) which may cause allergic reactions.

1. 6).