Skip to content

Opzelura® long-term safety profile and side effects

Opzelura® is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.1

Woman looking forward smiling

Opzelura® side effects

Opzelura® cream was generally well tolerated in eligible patients with non-segmental vitiligo, with few side effects, no serious TRAEs and <1% treatment-related discontinuations reported through 104 weeks in both cohorts in the TRuE-V LTE.2,3

Cohort A2

  • There were no cases of application site acne or application site pruritus among patients who applied Opzelura®
  • Treatment-related TEAEs (all mild or moderate; none were serious) among patients who applied Opzelura® were application site dermatitis (n=1), application site rash (n=1), and hyperlipidaemia (n=1)

Adverse events (AEs) in Cohort A2

n (%) Vehicle cream
(n=58) 		Opzelura®*
(n=81)
Patients with TEAE 21 (36.2) 35 (43.2)
Patients with treatment-related TEAE 3 (5.2) 3 (3.7)
Patients with application site reactions 2 (3.4) 5 (6.2)
Patients with serious TEAE† 0 1 (1.2)
Patients with TEAE leading to discontinuation 0 0
Patients with TEAE leading to dose reduction 0 1 (1.2)

Adapted from Harris JE, et al. 2023.2

Scroll right if necessary

Scroll horizontal icon

Cohort B3

  • Treatment-related TEAEs among patients who applied Opzelura® at any time were all mild or moderate (none serious)
  • Application site pruritus (n=4; 1.2%) was the most common treatment-related TEAE
  • Application site acne was reported in 6 patients (1.8%; 1 [0.3%] was treatment-related)

AEs in Cohort B3

n (%) Opzelura® from Day 1
(n=224) 		Vehicle to Opzelura®
(n=118)
Patients with TEAE 114 (50.9) 59 (50.0)
Patients with treatment-related TEAE 14 (6.3) 6 (5.1)
Patients with application site reactions 19 (8.5) 6 (5.1)
Patients with serious TEAE‡ 7 (3.1) 4 (3.4)
Patients with TEAE leading to discontinuation 0 1 (0.8)

Adapted from Rosmarin D, et al. 2023.3

Scroll right if necessary

Scroll horizontal icon

Opzelura® is contraindicated during pregnancy and breastfeeding.1

*Including 23 patients restarted active treatment upon relapse.2

†Uterine leiomyoma was considered by the investigators to be unrelated to treatment.2

‡No serious TEAEs were considered by the investigators to be related to treatment.3

Abbreviations

AE, adverse event; LTE; long-term extension; TEAE, treatment emergent adverse event; TRAE, treatment-related adverse event; TRuE-V, topical ruxolitinib evaluation in vitiligo study.

References

  1. Opzelura® (ruxolitinib) cream Summary of Product Characteristics. Incyte Biosciences UK Ltd.
  2. Harris JE, et al. American Academy of Dermatology (AAD) Annual Meeting, March 17–21, 2023. Oral presentation.
  3. Rosmarin D, et al. American Academy of Dermatology (AAD) Annual Meeting, March 17–21, 2023. Oral presentation.

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 by calling 00-800-0002-7423.

REPUBLIC OF IRELAND
Adverse events should be reported. Reporting forms and information can be found at HPRA Pharmacovigilance: www.hpra.ie. Adverse events should also be reported to Incyte by calling 1800‑456‑748.