Other safety alerts
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| Singapore: Opzelura® 15 mg/g cream (ruxolitinib phosphate): Important information regarding presence of particles in Opzelura® cream |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Rxilient Pte Ltd to inform healthcare professionals that small, visible crystal-like particles have been reported in Opzelura® (ruxolitinib) cream. The particles might form out of the active ingredient (ruxolitinib, as the dihydrate).
While these crystal-like particles may cause some discomfort to patients, they do not pose any significant safety risk to patients. The continued usage of the product, with the crystals like particles, over a short period of time is not expected to result in significant loss of efficacy of the treatment based on the available data. Healthcare professionals are advised to inform their patients of the possible presence of the particles and should they be present, to return the tube for a replacement.
The product is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. It is also indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/opzelura--15-mg-g-cream-(ruxolitinib-phosphate)--important-information-regarding-presence-of-particles-in-opzelura--cream
In Hong Kong, Lumirix Cream 15mg/g (HK-68437) is a pharmaceutical product containing ruxolitinib registered by Sky United Trading Limited (Sky United). It is a prescription-only medicine. The Department of Health (DH) has contacted Sky United to assess the local impact of the incident. Sky United is following up on the above issue, and will provide the impact assessment to the DH for consideration of action deemed appropriate.
Ends/Friday, Jun 13, 2025
Issued at HKT 17:45
As confirmed by Sky United, the presence of crystal-like particles in the product may cause minor discomfort but does not pose any significant safety risk to patients. Based on the data available, the continued usage of the product over a short period of time is not expected to result in significant loss of efficacy of the treatment. On 16 July 2025, Sky United has completed the issuance of notification letter to alert healthcare professionals in Hong Kong regarding the issue.
The company advises healthcare professionals to inform their patients about the potential presence of small, visible crystal-like particles in the product. If patients observe any such particles in the product, they should return the affected tube to the healthcare professional from whom it was obtained and request a replacement as soon as possible. Additionally, Sky United recommends that healthcare professionals contact the company to arrange product replacement upon receiving or dispensing the affected product containing visible crystal-like particles. Sky United will continue to monitor the quality of the product.
Content last updated: Monday, Jul 21, 2025
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