Adult dose and durationA thin layer twice a day, with a hard ceiling on how much skin and how much cream. US label verbatim: "Instruct patients to apply a thin layer of OPZELURA twice daily to affected areas of up to 10% body surface area." and "Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks." The strength is 1.5%, which is what the disease article also names. It is "for topical use only" and "not for ophthalmic, oral, or intravaginal use." - Months, and the label says so rather than leaving it open. US label verbatim: "Satisfactory patient response may require treatment with OPZELURA for more than 24 weeks. If the patient does not find the repigmentation meaningful by 24 weeks, the patient should be re-evaluated by the healthcare provider."
Paediatric doseAge restriction: minimum 144 months
(Licensed from 12 years in this disease, at the same strength and the same twice-daily application. US label verbatim: "The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients ages 12 years and older." and "The safety and effectiveness of OPZELURA have not been established in pediatric patients younger than 12 years of age with nonsegmental vitiligo." The 10% body-surface-area and 60 g per week limits apply to adolescents too.)
Dose by age| 12 years and over: | The same strength and the same twice-daily application as an adult. The 10% body-surface-area and 60 g per week limits apply too. |
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Dose sourceOPZELURA (ruxolitinib) cream 1.5% US prescribing information, boxed warning, section 1.2 Nonsegmental Vitiligo, section 2.2 Recommended Dosage and Administration for Nonsegmental Vitiligo and section 8.4 Pediatric Use (DailyMed SetID 24da5509-6631-4795-9d42-273faecd08e7)
WhyThe disease article names the drug and the strength, verbatim: "Topical JAK inhibitors (eg, ruxolitinib 1.5%): Effective, especially for facial vitiligo" and adds "Topical JAK inhibitors (eg, ruxolitinib) are well tolerated, with mild local reactions or acneiform eruptions." The US label's indication section names the disease, verbatim: "OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older." The card carried a potent steroid and a calcineurin inhibitor, which is where the article puts the first line; this is the drug it names next, and the one licensed for the disease itself. Egypt registers a matching product - RUXOTOP 1.5% cream 60 g, filed under the drug class VITILIGO, at about 3,210 EGP a tube - so the cost of the 60 g weekly ceiling is a real conversation to have before starting.
Cautions- RED FLAG - boxed warning, and it is the oral JAK inhibitor class warning carried onto a cream. US label verbatim: "WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS." On infection: "Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled." Tuberculosis and herpes zoster are named. Latent tuberculosis is common in Egypt.
- Malignancy and cardiovascular events, verbatim from the same boxed warning: "Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions." and "Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke." and "Thromboembolic events were observed in trials with OPZELURA... Avoid OPZELURA in patients at risk." Current and former smokers are named as being at additional risk.
- The two limits are the safety mechanism, not packaging advice. Ten per cent of body surface area and one 60 g tube a week are what keep systemic absorption low; a patient with widespread vitiligo who treats everything at once is taking a systemic JAK inhibitor by another route.
- Not to be combined with the other immunosuppressants. US label verbatim: "Use of OPZELURA in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended."
- Vitiligo repigmentation is slow and sun protection stays part of the treatment. Twenty-four weeks is the label's own review point, and depigmented skin burns.
- Do not confuse it with the oral drug. JAKAVI (ruxolitinib) tablets on the Egyptian register are a systemic antineoplastic JAK inhibitor for myelofibrosis and polycythaemia, priced in the tens of thousands of pounds; what is prescribed here is a 1.5% cream. They share an ingredient name and nothing else.