Topical ruloxitinib

Oplezura®

Incyte Biosciences

Inhibition of the selective activation of JAK1/JAK2; blockade of the intracellular signalling cascade of the JAK-STAT signalling pathway, resulting in a reduction in the inflammatory response.

Not yet authorised in Switzerland.

Opzelura is used to treat non-segmental vitiligo affecting the face in adults and adolescents aged 12 years and over.

No

Not yet authorised in Switzerland; off-label use.

Cream

Insufficient data

Not necessary; clinical monitoring only.

Every 6 months.

Topical

The recommended dose is a thin layer of cream, applied twice daily to the depigmented areas of skin, covering no more than 10 per cent of the body surface area; there must be an interval of at least 8 hours between applications of ruxolitinib cream.

10 per cent of the body surface area corresponds to an area 10 times the size of the palm of one hand with all five fingers. No more than two 100 g tubes should be used per month.

Treatment may need to continue beyond 24 weeks to achieve satisfactory repigmentation. If, by week 52, less than 25 per cent of the treated areas have repigmented, discontinuation of treatment should be considered.

The cream is not intended for use around the eyes, for oral use or for intravaginal use. In the event of accidental contact with the eyes or mucous membranes, the cream should be thoroughly wiped off and/or rinsed off with water. Women of childbearing age must use a reliable method of contraception during treatment and for 4 weeks after treatment has ended.

Use in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

952 (100 g cream, 15 mg/g).

Insufficient data

Treatment may need to continue for longer than six months to achieve satisfactory repigmentation of the skin.

Insufficient data

Pregnancy and breastfeeding.
Hypersensitivity to the active substance or to any of the other ingredients.

Acne-like lesions; possibly an increased risk of NMSC (insufficient data).

Insufficient data

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