Overview

Opzelura is a medicine used for treating non-segmental vitiligo, a disease that causes patches of skin to lose colour on both sides of the body. In patients with vitiligo, the immune system (the body’s natural defences) attacks melanocytes (the skin cells that make pigment), causing patches of pale pink or white skin (depigmentation). Opzelura is used in adults and adolescents from 12 years of age with non-segmental vitiligo that also affects the face.

Opzelura contains the active substance ruxolitinib.

Opzelura can only be obtained with a prescription and treatment should be started and supervised by a doctor with experience in the diagnosis and treatment of non-segmental vitiligo.

Opzelura is available as a cream to be applied on the depigmented skin twice a day. Opzelura should not be applied to more than 10% of the body at the same time.

Treatment may be needed for more than 6 months to obtain satisfactory repigmentation of the skin (return of skin colour). The doctor may stop treatment if there is no satisfactory improvement after one year of treatment. 

For more information about using Opzelura, see the package leaflet or contact your doctor or pharmacist.

The active substance in Opzelura, ruxolitinib, works by blocking enzymes known as Janus kinase (JAK) 1 and 2, which are involved in the activity of a substance called interferon-gamma (IFN-gamma). In vitiligo, IFN-gamma is thought to play a role in the activity of the cells of the immune system that attack melanocytes. By blocking JAK1 and JAK2, ruxolitinib reduces the immune system’s ability to destroy melanocytes, allowing them to produce pigment.

In 2 main studies, Opzelura was shown to improve repigmentation compared with placebo (dummy treatment).

The main measure of effectiveness was the proportion of patients who achieved an improvement of at least 75% in the pigmentation of their face as measured using a standard score for facial vitiligo (F-VASI75) after 6 months.

The 2 studies involved a total of 661 patients with non-segmental vitiligo. On average, around 31% of patients who received Opzelura achieved an improvement of at least 75% in the pigmentation of their face after 6 months of treatment, compared with around 10% of those who received placebo. Using a standard score for total body pigmentation (T-VASI50), the studies further showed that, after 6 months, total body pigmentation improved by at least 50% in 22% of patients who used Opzelura compared with 6% of those receiving placebo.

For the full list of side effects and restrictions with Opzelura, see the package leaflet.

The most common side effect with Opzelura (which may affect up to 1 in 10 people) is acne at the site where the medicine was applied.

Women who are pregnant or breastfeeding must not use Opzelura.

Opzelura has been shown to have beneficial effects on the repigmentation of the skin in patients with non-segmental vitiligo. In terms of safety, the side effects of Opzelura are considered acceptable. While ruxolitinib medicines taken by mouth are associated with serious side effects, these effects are not expected to occur with Opzelura since it is used as a cream, provided that it is not used on more than 10% of the body in one application.

The European Medicines Agency therefore decided that Opzelura’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opzelura have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Opzelura are continuously monitored. Suspected side effects reported with Opzelura are carefully evaluated and any necessary action taken to protect patients.

Opzelura received a marketing authorisation valid throughout the EU on 19 April 2023.

Opzelura : EPAR - Medicine overview

English (EN) (119.97 KB - PDF)View
български (BG) (143.77 KB - PDF)
español (ES) (119.61 KB - PDF)
čeština (CS) (140.92 KB - PDF)
dansk (DA) (118.79 KB - PDF)
Deutsch (DE) (121.61 KB - PDF)
eesti keel (ET) (108.21 KB - PDF)
ελληνικά (EL) (142.91 KB - PDF)
français (FR) (127.22 KB - PDF)
hrvatski (HR) (138.23 KB - PDF)
italiano (IT) (118.73 KB - PDF)
latviešu valoda (LV) (151.03 KB - PDF)
lietuvių kalba (LT) (157.66 KB - PDF)
magyar (HU) (141.55 KB - PDF)
Malti (MT) (143.31 KB - PDF)
Nederlands (NL) (119.77 KB - PDF)
polski (PL) (143.4 KB - PDF)
português (PT) (119.94 KB - PDF)
română (RO) (140.2 KB - PDF)
slovenčina (SK) (140.91 KB - PDF)
slovenščina (SL) (139.17 KB - PDF)
Suomi (FI) (117.94 KB - PDF)
svenska (SV) (118.53 KB - PDF)

Opzelura : EPAR - Risk management plan summary

English (EN) (180.77 KB - PDF)View

Product information

Opzelura : EPAR - Product Information

English (EN) (475.6 KB - PDF)View
български (BG) (500.64 KB - PDF)
español (ES) (376.47 KB - PDF)
čeština (CS) (443.66 KB - PDF)
dansk (DA) (373.76 KB - PDF)
Deutsch (DE) (366.05 KB - PDF)
eesti keel (ET) (438.33 KB - PDF)
ελληνικά (EL) (465.07 KB - PDF)
français (FR) (438.77 KB - PDF)
hrvatski (HR) (392.69 KB - PDF)
íslenska (IS) (453.19 KB - PDF)
italiano (IT) (365.98 KB - PDF)
latviešu valoda (LV) (393.97 KB - PDF)
lietuvių kalba (LT) (431.38 KB - PDF)
magyar (HU) (444.92 KB - PDF)
Malti (MT) (516.37 KB - PDF)
Nederlands (NL) (369.16 KB - PDF)
norsk (NO) (378.86 KB - PDF)
polski (PL) (554.94 KB - PDF)
português (PT) (341.82 KB - PDF)
română (RO) (402.67 KB - PDF)
slovenčina (SK) (463.33 KB - PDF)
slovenščina (SL) (407.87 KB - PDF)
Suomi (FI) (447.75 KB - PDF)
svenska (SV) (321.39 KB - PDF)

Latest procedure affecting product information: II/0003

19/10/2023

Globe icon

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Opzelura : EPAR - All Authorised Presentations

English (EN) (37.08 KB - PDF)View
български (BG) (34.5 KB - PDF)
español (ES) (36.43 KB - PDF)
čeština (CS) (31.48 KB - PDF)
dansk (DA) (57.03 KB - PDF)
Deutsch (DE) (10.03 KB - PDF)
eesti keel (ET) (9.74 KB - PDF)
ελληνικά (EL) (32.82 KB - PDF)
français (FR) (10.14 KB - PDF)
hrvatski (HR) (27.82 KB - PDF)
íslenska (IS) (10 KB - PDF)
italiano (IT) (9.52 KB - PDF)
latviešu valoda (LV) (63.61 KB - PDF)
lietuvių kalba (LT) (55.33 KB - PDF)
magyar (HU) (29.59 KB - PDF)
Malti (MT) (30.98 KB - PDF)
Nederlands (NL) (35.01 KB - PDF)
norsk (NO) (35.22 KB - PDF)
polski (PL) (56.79 KB - PDF)
português (PT) (35.14 KB - PDF)
română (RO) (54.74 KB - PDF)
slovenčina (SK) (57.71 KB - PDF)
slovenščina (SL) (43.11 KB - PDF)
Suomi (FI) (36.02 KB - PDF)
svenska (SV) (35.15 KB - PDF)

Product details

Name of medicine
Opzelura
Active substance
ruxolitinib phosphate
International non-proprietary name (INN) or common name
ruxolitinib
Therapeutic area (MeSH)
Vitiligo
Anatomical therapeutic chemical (ATC) code
D11AH

Pharmacotherapeutic group

Other dermatological preparations

Therapeutic indication

Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Authorisation details

EMA product number
EMEA/H/C/005843
Marketing authorisation holder
Incyte Biosciences Distribution B.V.

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Opinion adopted
23/02/2023
Marketing authorisation issued
19/04/2023
Revision
2

Assessment history

Opzelura : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (162.05 KB - PDF)View

Opzelura : EPAR - Public Assessment Report

English (EN) (5.1 MB - PDF)View

CHMP summary of positive opinion for Opzelura

English (EN) (117.47 KB - PDF)View
This page was last updated on

How useful do you find this page?

Average: