OPZELURA 15 mg /G Cream

Зміст інструкції

1. Opzelura 15 mg/g cream
   1. What is Opzelura and what it is used for
   2. What you need to know before using Opzelura
   3. How to use Opzelura
   4. Possible side effects
   5. How to store Opzelura
   6. Contents of the pack and other information

Opzelura 15 mg/g cream

ruxolitinib

Read this leaflet carefully before you use this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Opzelura is and what it is used for
• 2. What you need to know before you use Opzelura
• 3. How to use Opzelura
• 4. Possible side effects
• 5. How to store Opzelura
• 6. Contents of the pack and other information

1. What is Opzelura and what it is used for

Opzelura contains the active substance ruxolitinib. It belongs to a group of medicines called
Janus kinase inhibitors.
Opzelura is used on the skin for the treatment of vitiligo with facial involvement in adults
and adolescents starting from 12 years of age. Vitiligo is an autoimmune disease in which the
immune system attacks the body's cells that produce skin pigment called
melanin. This causes a loss of melanin leading to the formation of white or
pale pink spots on the skin. In vitiligo, ruxolitinib reduces the activity of the immune system against the
cells that produce melanin, allowing the skin to produce pigment and restore its
normal coloration.

2. What you need to know before using Opzelura

Do not use Opzelura

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

Warnings and precautions
Talk to your doctor or pharmacist before using Opzelura.
Opzelura should not be used on the lips, in the eyes, in the mouth or in the vagina. If the cream
accidentally gets into these areas, remove it carefully and/or wash it away with water.

Children under 12 years of age
Do not give Opzelura to children under 12 years of age, because this medicine has not been
studied in this age group.

Other medicines and Opzelura
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
It is not recommended to use Opzelura at the same time as other medicines on the skin to be treated, because
this use has not been studied.
After applying Opzelura, wait at least 2 hours before applying other medicines, sunscreens or
body creams/oils to the same area of skin.

Pregnancy and breastfeeding
Opzelura should not be used by pregnant women or women who are breastfeeding, because this
use has not been studied. If you are a woman of childbearing potential, you should use effective
contraceptive measures during treatment and for 4 weeks after the last application of Opzelura.
It is not known whether ruxolitinib passes into breast milk after being applied to the skin. The effects of this
medicine on breastfed babies are unknown; for this reason, Opzelura should not be used if you are
breastfeeding or plan to breastfeed. You may be able to start breastfeeding about
four weeks after applying Opzelura for the last time.

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

Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methyl parahydroxybenzoate,
propyl parahydroxybenzoate and butylhydroxytoluene

• This medicine contains, per gram of cream, 150 mg of propylene glycol (E1520), which can cause skin irritation.
• Cetyl alcohol and stearyl alcohol can cause localised skin reactions (e.g. contact dermatitis).
• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate can cause allergic reactions (including delayed reactions).
• Butylhydroxytoluene (E321) can cause localised skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes.

3. How to use Opzelura

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.

Recommended dose

• Apply a thin layer of cream to the areas of skin to be treated twice daily. Wait at least 8 hours between applications.
• The cream should not be used on more than 10% (one-tenth) of the body surface area. The extent of this surface area is equivalent to ten times the palm of your hand, including the five fingers.

Method of administration

• This medicine should only be used on the skin.
• Do not apply the medicine to areas of skin other than those indicated by your doctor. The medicine should be applied to the smallest possible area of skin necessary.
• Wash your hands after applying this medicine, unless your hands themselves have been treated. If this medicine is applied by another person, they should wash their hands after application.
• After applying Opzelura, avoid washing the treated skin for at least 2 hours.

Duration of use
Your doctor will determine how long you should use this cream.
A minimum duration of 6 months is recommended, but more than 12 months may be
necessary for satisfactory treatment. If the level of repigmentation achieved in the treated areas is satisfactory,
consult your doctor to discuss possible discontinuation of treatment in these areas. If loss of repigmentation occurs
after stopping treatment, consult your doctor.
Do not use more than two 100 gram tubes in one month.

If you use more Opzelura than you should
If this happens, remove the excess cream.

If you forget to use Opzelura
If you forget to apply the cream at the scheduled time, apply it as soon as you remember, then
continue following the normal dosing schedule. However, if the next dose is
scheduled within 8 hours, skip the missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Opzelura:

Common(may affect up to 1 in 10 people)

• acne at the application site

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Opzelura

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tube and the cardboard box
after “Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
Once opened, use the cream within 6 months, but not after the expiry date.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Opzelura contains

• The active ingredient is ruxolitinib. One 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, methylparaben (E218), phenoxyethanol, polysorbate 20 (E432), propylene glycol (E1520), propylparaben, purified water, stearyl alcohol, xanthan gum (E415).

See section 2 “Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methyl
paraben, propylparaben and butylhydroxytoluene”.

Description of the appearance of Opzelura and contents of the pack
Opzelura is a cream ranging in colour from white to off-white and is supplied in a tube containing 100 g of
cream. Each cardboard box contains one tube.

Marketing authorisation holder and manufacturer
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam
Netherlands
Further detailed information on this medicine is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.