OPZELURA 15 mg/g CREAM

Introduction

Package Leaflet: Information for the Patient

Opzelura 15mg/g Cream

ruxolitinib

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

• Keep this package leaflet, 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 only, 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Opzelura and what is it used for
2. What you need to know before starting to use Opzelura
3. How to use Opzelura
4. Possible side effects
5. Storage of Opzelura
6. Package Contents and Additional Information

1. What is Opzelura and what is it used for

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

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

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

Do not use Opzelura

• if you are allergic to ruxolitinib or any of the other components of this medication (listed in section 6).
• if you are pregnant or breastfeeding.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Opzelura.

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

Children under 12 years

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

Other medications and Opzelura

Tell your doctor or pharmacist if you are using, have recently used, 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 this has not been studied.

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

Pregnancy and Breastfeeding

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

It is not known whether ruxolitinib passes into breast milk after application to the skin. The effects of this medication on infants are unknown; therefore, you should not use Opzelura if you are breastfeeding or plan to breastfeed. You can start breastfeeding approximately 4 weeks after the last application of Opzelura.

Driving and Using Machines

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 150 mg of propylene glycol (E1520) per 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.

3. How to use Opzelura

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Recommended dose

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

Method of administration

• This medication is intended for use on the skin only.
• Do not apply it to skin surfaces other than those indicated by your doctor. The medication should only be used on the minimum necessary skin area.
• Wash your hands after applying the medication, unless you are treating your hands. If someone else applies the medication, 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 adequate treatment may require more than 12 months. If you achieve adequate repigmentation of the treated areas, consult your doctor about possible discontinuation of treatment in those areas. Consult your doctor if you lose repigmentation after discontinuing treatment.

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

If you use more Opzelura than you should

If this happens, remove the excess cream.

If you forget to use Opzelura

If you have forgotten to apply the cream within the scheduled time, do so as soon as you remember and continue with the normal dosage regimen. 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.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been reported with Opzelura:

Common(may affect up to 1 in 10 patients)

• acne at the application site

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Opzelura

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

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

Do not store above 30°C.

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

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Opzelura

• The active ingredient is ruxolitinib.

Each gram of cream contains 15 mg of ruxolitinib.

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

See section 2 "Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, and butylhydroxytoluene".

Appearance and Package Contents

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

Marketing Authorization Holder and Manufacturer

Incyte Biosciences Distribution B.V.

Paasheuvelweg 25

1105 BP Amsterdam

Netherlands

Date of the last revision of this package leaflet:

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu