Opzelura 15 mg/g cream
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Opzelura 15 mg/g cream
ruxolitinib
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Opzelura is and what it is used for
- What you need to know before using Opzelura
- How to use Opzelura
- Possible side effects
- How to store Opzelura
- Contents of the pack and other information
1. What Opzelura is and what it is used for
Opzelura contains the active substance ruxolitinib. It belongs to a group of medicines known as Janus kinase inhibitors.
Opzelura is used topically to treat facial vitiligo 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 skin pigment melanin. This leads to loss of melanin, resulting in pale pink or white patches on the skin. In vitiligo, ruxolitinib reduces immune system activity against melanin-producing cells, allowing the skin to produce pigment and regain its normal colour.
2. What you need to know before using Opzelura
Do not use Opzelura
- if you are allergic to ruxolitinib or to 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 starting to use Opzelura.
Opzelura is not intended for use on the lips, eyes, mouth, or vagina. If the cream accidentally comes into contact with these areas, remove and/or rinse thoroughly with abundant water.
Children under 12 years of age
Opzelura is not indicated for use in children under 12 years of age, as it has not been studied in this age group.
Other medicines and Opzelura
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
It is not recommended to use Opzelura simultaneously with other topical medicines on the affected skin area, as this has not been studied.
After applying Opzelura, wait at least 2 hours before applying other medicines, sunscreens, or body creams/oils to the same skin area.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, you must not use Opzelura, as it has not been investigated. If you are a woman of childbearing potential, you should use an effective method of contraception during treatment and for 4 weeks after the last application of Opzelura.
It is unknown whether ruxolitinib passes into breast milk after topical application. The effects of this medicine on infants are unknown; therefore, you must not use Opzelura if you are breastfeeding or plan to breastfeed. You may begin breastfeeding approximately four weeks after the last application of Opzelura.
Driving and using machines
It is unlikely that Opzelura will affect your ability to drive or operate machinery.
Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methylparaben, propylparaben, butylated hydroxytoluene, and polysorbate 20
- This medicine 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).
- Methylparaben (E218) and propylparaben may cause allergic reactions (possibly delayed).
- Butylated hydroxytoluene (E321) may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes.
- Polysorbates may cause allergic reactions.
3. How to use Opzelura
Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dose
- Apply a thin layer of cream twice daily to the affected areas of skin. Allow at least 8 hours between applications.
- Do not apply cream to more than 10% (one-tenth) of the body surface. This body area is equivalent to ten times the size of the palm of one hand with all five fingers extended.
Method of administration
- This medicine is intended for topical use only.
- Do not apply to skin areas other than those indicated by your doctor. The medicine should only be used on the minimum necessary area of skin.
- Wash your hands after applying the medicine, unless you are treating your hands. If another person applies the medicine for you, they must wash their hands after administration.
- Avoid washing the treated skin for at least 2 hours after application of Opzelura.
Duration of use
Your doctor will decide how long you should use the cream.
A minimum duration of 6 months is recommended, but adequate treatment may require more than 12 months. If you achieve appropriate repigmentation of the treated areas, consult your doctor about the possibility of discontinuing treatment in those areas. Consult your doctor if you lose repigmentation after stopping 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, do so as soon as you remember and then continue with your normal dosing schedule. However, if the next scheduled dose is due within 8 hours, do not apply the missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have been reported with Opzelura:
Frequent (may affect up to 1 in 10 people)
- acne at the application site
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Opzelura
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after EXP. The expiry date is the last day of the month indicated.
Do not store above 30°C.
After opening the tube, use the cream within 6 months, but not beyond the expiry date.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Opzelura
- The active substance is ruxolitinib.
Each gram of cream contains 15 mg of ruxolitinib.
- The other components are butylhydroxytoluene (E321), cetyl alcohol, dimethicone (E900), disodium edetate (E385), glyceryl stearate, paraffin (E905), macrogol, medium-chain triglycerides, methylparahydroxybenzoate (E218), phenoxyethanol, phosphoric acid (E338), polysorbate 20 (E432), propylene glycol (E1520), propylparahydroxybenzoate, purified water, stearyl alcohol, and xanthan gum (E415).
See section 2 “Opzelura contains propylene glycol, cetyl alcohol, stearyl alcohol, methylparahydroxybenzoate, propylparahydroxybenzoate, butylhydroxytoluene and polysorbate 20”.
Nature and contents of the container
Opzelura cream is white to off-white in colour and is supplied in a tube containing 100 g of cream. One tube in each carton.
Marketing Authorisation Holder and Manufacturer
Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands
Date of the most recent revision of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu