Lumirix

Non-segmental vitiligo w/ facial involvement in adults & adolescents ≥12 yr.

Adult & adolescent Apply thin layer bd to depigmented skin areas up to max of 10% BSA, w/ min of 8 hr between 2 applications. Use at the smallest skin area necessary. Use no more than 2 tubes/mth. Consider treatment discontinuation if <25% repigmentation in treated areas at wk 52. Avoid washing treated skin for at least 2 hr after application.

Hypersensitivity. Pregnancy & lactation.

Not for ophth, oral, or intravaginal use. Thoroughly wipe off &/or rinse w/ water in cases of accidental exposure in eyes or mucous membranes. Risk of malignancy & lymphoproliferative disorders were observed in patients receiving oral JAKs. Consider benefits & risks prior to initiating or continuing therapy, particularly in patients w/ known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop malignancy when on treatment, & patients who are current or past smokers. Risk of non-melanoma skin cancers, including basal cell & squamous cell carcinoma. Perform periodic skin exam during & following treatment as appropriate. Limit exposure to sunlight & UV light. Risk of major adverse CV events were observed in patients receiving oral JAKs. Consider benefits & risks prior to initiating or continuing therapy, particularly in patients who are current or past smokers & patients w/ other CV risk factors. Discontinue in case of MI or stroke. Risk of thromboembolic events. Avoid in patients who may be at increased risk of thrombosis. Discontinue if symptoms of thrombosis occur. Contains propylene glycol, which may cause skin irritation. Contains cetyl alcohol & stearyl alcohol, which may cause local skin reactions (eg, contact dermatitis). Contains methyl parahydroxybenzoate & propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed). Contains butylated hydroxytoluene, which may cause local skin reactions (eg, contact dermatitis) or irritation to eyes & mucous membranes. No studies have been performed in patients w/ hepatic or renal impairment. Should not be used by patients w/ ESRD. Women of childbearing potential should use effective contraception during treatment & for 4 wk after treatment discontinuation. Discontinue treatment approx 4 wk before beginning of breastfeeding. Safety & efficacy in childn <12 yr have not been established.

Application site acne.

Doubled plasma AUC w/ potent CYP3A4 inhibitor. Modest increase in plasma AUC w/ moderate CYP3A4 inhibitor. Co-application on the same skin areas is not recommended w/ other topical medicinal products used to treat vitiligo.

Other Dermatologicals

D11AH09 - ruxolitinib ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.

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