Summary

• Complaints about the presence of small, visible crystal-like particles in Opzelura (ruxolitinib) cream have been reported. The particles might form out of the active ingredient (ruxolitinib, as the dihydrate).
• While these crystal-like particles may cause some discomfort to patients when they apply the cream, they do not pose any significant safety risk to patients, nor are expected to impact the product’s efficacy.
• Patients should be advised that small, visible crystal-like particles may be present in Opzelura.
• If a patient observes crystals in Opzelura cream they should stop treatment with the affected tube, return the tube to the pharmacy where they obtained it and request a replacement tube as soon as possible.
• A pharmacist who receives a tube of Opzelura containing visible crystal-like particles should contact Incyte’s Medical Information Team at  eumedinfo@incyte.com, and Incyte will arrange for a replacement tube to be sent to them, free of charge.