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Opzelura® (ruxolitinib) dosing and administration

Opzelura® is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age1

Man looking up smiling

Convenient topical application of Opzelura® (ruxolitinib) cream 15 mg/g

Opzelura® cream contains 15 mg/g ruxolitinib and is the first approved topical Janus kinase (JAK) inhibitor for vitiligo. Opzelura® offers convenient application and is the only approved treatment for non-segmental vitiligo repigmentation.*1,2

Quotation mark Will I be able to wear makeup with my treatment? Quotation mark

Now you can.†‡1

An effective cream that can be worn underneath makeup‡1

Woman with non-segmental vitiligo surrounded by information on how to apply Opzelura® (ruxolitinib) topical cream 15 mg/g

APPLY IN A THIN LAYER TWICE DAILY TO AFFECTED AREAS OF UP TO 10% OF TOTAL BSA

Applying Opzelura® over makeup and sunscreen

Opzelura® cream (15 mg/g) for vitiligo can be effectively used on sensitive areas around the eyes, external genitalia and mouth.1 Furthermore, Opzelura® can be used under makeup and sunscreen; however as a precaution, sunscreen and/or makeup should be applied at least two hours after using Opzelura® to ensure optimal absorption into the skin.1

Opzelura® (ruxolitinib) application full information

Opzelura® is a non-greasy, non-steroidal cream, white to off-white in colour and for cutaneous use only.1 Healthcare professionals (HCPs) should advise their patients to apply the cream as a thin layer to their depigmented skin.1

Patients should be advised to wait at least two hours before applying other medicines, body creams or oils to the same skin area. Patients should avoid washing the treated area for at least two hours. Opzelura® is not for ophthalmic, oral or intravaginal use.§1 Opzelura® should not be applied to the lips to avoid ingestion.1 Patients should be instructed to wash their hands after applying the cream, unless it is their hands that are being treated. If someone else applies the cream to the patient, they should wash their hands after application.1

Opzelura® was generally well tolerated in clinical trials but patients should be advised that the most common side effect of Opzelura® was application site acne, observed in 5.8% of patients across both TRuE-V1 and TRuE-V2 clinical trials.1

Dosing of Opzelura® (ruxolitinib) cream 15 mg/g

The recommended dose for Opzelura® is a thin layer of cream applied twice daily cutaneously to the depigmented skin.1 For each application, Opzelura® should be applied up to a maximum of 10% of body surface area (BSA), with a minimum of eight hours between applications.1

A BSA of 10% represents approximately 10 times the palm of one hand including fingers. No more than two 100 g tubes a month should be used by the patient.1 There is no need to consider tapering Opzelura® therapy.1

Opzelura® dose adjustments

Dosing of Opzelura® is the same for adolescents (aged 12–17 years old) as it is for adults, and no dose adjustments are required for patients with hepatic or renal impairment or in those aged 65 or older.¶1

Prescribing Opzelura® (ruxolitinib) cream 15mg/g

Opzelura® is approved for use as a treatment for non-segmental vitiligo with facial involvement in adults and adolescents from 12 years old.

Non-segmental vitiligo depigmentation is driven by aberrant JAK/signal transducer and activator of transcription (STAT) signalling, and Opzelura®, a topical JAK inhibitor, looks to restore the normal functioning of the immune system and promote repigmentation.6,7

Clinical trials have shown favourable results with a 75% improvement in facial repigmentation achieved by approximately 1 in 2 patients after 52 weeks of Opzelura® treatment in the TRuE-V1 trial.8

Discussions around treatment with Opzelura® should include managing patient expectations, explaining that repigmentation is gradual and requires persistence.1,2 Satisfactory repigmentation may require treatment beyond 24 weeks and if there is less than 25% repigmentation at Week 52, treatment discontinuation should be considered.

Important Opzelura® prescribing information

Opzelura® should not be prescribed to:

  • Children under the age of 12
  • Patients allergic to ruxolitinib or any of the other ingredients/excipients of the medicine
  • Patients who are pregnant or breastfeeding

Please refer to the full SmPC before prescribing the product.

Opzelura® is contraindicated during pregnancy and breastfeeding.

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

†Patient quotes are fictional.

‡Other topical medicinal products, sunscreen or emollients may be applied with a minimum of two hours after the application of Opzelura®.

§In cases of accidental ophthalmic, oral mucosa or intravaginal exposure, the cream should be thoroughly wiped off and/or rinsed with water.

As a precautionary measure, Opzelura® cream should not be used by patients with end stage renal disease, due to lack of data regarding the safety in this population.

Abbreviations

BSA, body surface area; HCP, healthcare professional; JAK, Janus kinase; STAT, signal transducer and activator of transcription.

References

  1. Opzelura® (ruxolitinib cream) Summary of Product Characteristics. Incyte Biosciences UK Ltd. November 2023.
  2. Hospital Pharmacy Europe. Ruxolitinib cream gains MHRA approval for non-segmental vitiligo. Available at: https://hospitalpharmacyeurope.com/clinical-zones/dermatology/ruxolitinib-cream-gains-mhra-approval-for-non-segmental-vitiligo/ (Accessed March 2024).
  3. Eleftheriadou V, et al. Br J Dermatol. 2022;186(1):18–29.
  4. Bagherani N. Role of corticosteroids in treatment of vitiligo. In: Magdeldin S., editor. State of the Art of Therapeutic Endocrinology. InTech; 2012.
  5. Ko HC, et al. Ann Dermatol. 2018;30(2):173–178.
  6. Strassner JP, et al. Curr Opin Immunol. 2016;43:81–88.
  7. Frisoli ML, et al. Annu Rev Immunol. 2020;38:621–648.
  8. Rosmarin D, et al. N Engl J Med. 2022;387(16):1445–1455.

UNITED KINGDOM
Adverse events should be reported. Reporting forms and information can be found at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Incyte immediately by calling 03301003677 (Great Britain) 00-800-0002-7423 (United Kingdom (Northern Ireland)).

REPUBLIC OF IRELAND
Adverse events should be reported. Reporting forms and information can be found at: HPRA Pharmacovigilance website: www.hpra.ie Adverse events should also be reported to Incyte by calling 00-800-0002-7423.