Product Information for the Patient

Opzelura 15mg/g Cream

ruxolitinib

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1.What is Opzelura and how is it used

2.What you need to know before starting to use Opzelura

3.How to use Opzelura

4.Possible adverse effects

5.Storage of Opzelura

6.Contents of the package and additional information

Opzelura contains the active ingredient ruxolitinib. It belongs to a group of medicines known as Janus kinase inhibitors.

Opzelura is applied to the skin to treat vitiligo with facial involvement in adults and adolescents aged 12 years and older. Vitiligo is an autoimmune disease, in which the body's immune system attacks the cells that produce the skin pigment melanin. This results in the loss of melanin, causing pale pink or white patches on the skin. In vitiligo, ruxolitinib reduces the immune system's activity against melanin-producing cells, allowing the skin to produce pigment and regain its normal color.

No use Opzelura

• If you are allergic to ruxolitinib or any of the other components of this medication (listed in section6).
• If you are pregnant or breastfeeding.

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use Opzelura

Opzelura is not indicated for use on lips, eyes, mouth, or vagina. If the cream comes into contact with these areas by accident, remove and/or rinse the cream with plenty of water.

Niños menores de 12 años

Opzelura is not indicated for use in children under 12years, as it has not been studied in this age group.

Otros medicamentos y Opzelura

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is not recommended to use Opzelura at the same time as other medications on the affected skin, as it has not been studied.

After applying Opzelura, wait at least 2 hours before applying other medications, sunscreens, or creams/oils on the same area of the skin.

Embarazo y lactancia

If you are pregnant or breastfeeding, do not use Opzelura, as it has not been investigated. If you are a fertile woman, you should use an effective contraceptive method during treatment and for the 4 weeks following the last application of Opzelura.

The passage of ruxolitinib into breast milk after its application to the skin is unknown. The effects of this medication on infants are unknown; therefore, do not use Opzelura if you are breastfeeding or intend to be.You may initiate breastfeeding approximately four weeks after the last application of Opzelura.

Conducción y uso de máquinas

It is unlikely that Opzelura will affect your ability to drive or use machines.

Opzeluracontains propylene glycol, cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and butylhydroxytoluene

• This medication contains 150mg of propylene glycol (E1520) in each gram of cream, which may cause skin irritation.
• Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g., contact dermatitis).
• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
• Butylhydroxytoluene (E321) may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended Dose

• Apply a thin layer of cream twice a day to the affected skin areas. Wait at least 8 hours between applications.
• Do not apply cream to more than 10% (one-tenth) of the body. This body area represents the equivalent of ten times the palm of one hand with five fingers.

Administration Form

• This medication is indicated only for use on the skin.
• Do not apply it to skin surfaces other than those indicated by your doctor. The medication should only be used on the minimum area of skin necessary.
• Wash your hands after applying the medication, unless you are treating your hands. If someone else applies the medication to you, they should wash their hands after application.
• Avoid washing the treated skin for at least 2 hours after applying Opzelura.

Duration of Use

Your doctor will decide how long you should apply the cream.

A minimum duration of 6 months is recommended, but a suitable treatment may require more than 12 months. If you achieve adequate repigmentation of the treated areas, consult your doctor about possible interruption of treatment in those areas. Consult your doctor if you lose repigmentation after interrupting treatment.

Do not use more than two 100-gram tubes per month.

If You Use More Opzelura Than You Should

If this occurs, remove the excess cream.

If You Forget to Use Opzelura

If you forget to apply the cream at the scheduled time, apply it when you remember and continue with the normal dosing schedule. However, if the next scheduled dose is within 8 hours, do not apply the missed dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been reported with Opzelura:

Frequent(may affect up to 1 in 10 patients)

• acne at the application site

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist,even if it is a possibleadverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the tube and on the box after EXP. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Once the tube is opened, use the cream within a period of 6 months, but not after the expiration date.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Opzelura

• The active ingredient is ruxolitinib.

Each gram of cream contains 15mg of ruxolitinib.

• The other components are butylhydroxytoluene (E321), cetyl alcohol, dimethicone (E900), disodium edetate (E385), glyceryl stearate, paraffin (E905), macrogol, medium-chain triglycerides, methyl parahydroxybenzoate (E218), phenoxethanol, polysorbate 20 (E432), propylene glycol (E1520), propyl parahydroxybenzoate, purified water, stearyl alcohol, and xanthan gum (E415).

See section2 “Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and butylhydroxytoluene”.

Appearance of the product and content of the container

Opzelura cream is white to off-white in color and is supplied in a 100g tube. One tube per carton.

Marketing authorization holder and responsible manufacturer

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25

1105 BP Amsterdam

Netherlands

Last review date of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu