Ruxolitinib, a Janus kinase (JAK) inhibitor, inhibits JAK1 and JAK2 which mediate the signaling of a number of cytokines and growth factors that are important for hematopoiesis and immune function. JAK signaling involves recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus leading to modulation of gene expression. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness is not currently known.

OPZELURA is a Janus kinase (JAK) inhibitor indicated for:

• the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 
• the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Atopic Dermatitis

• Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 20% body surface area.
• Do not use OPZELURA with occlusive dressings.

Adult and Pediatric Patients 12 Years of Age and Older

• Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks.

Pediatric Patients 2 to 11 Years of Age

• Do not use more than one 60 gram tube of OPZELURA per 2 weeks.

Nonsegmental Vitiligo

• Apply a thin layer of OPZELURA topically twice daily to affected areas of up to 10% body surface area.
• Do not use more than one 60 gram tube of OPZELURA per week or one 100 gram tube per 2 weeks. 

• In atopic dermatitis, the most common adverse reactions (incidence ≥ 1%) are nasopharyngitis, diarrhea, bronchitis, ear infection, eosinophil count increased, urticaria, folliculitis, tonsillitis, rhinorrhea, upper respiratory tract infection, COVID-19, application site reactions, pyrexia, and white blood cell decreased.
• In nonsegmental vitiligo, the most common adverse reactions (incidence ≥ 1%) are application site acne, application site pruritus, nasopharyngitis, headache, urinary tract infection, application site erythema, and pyrexia.

None

• Serious Infections: Serious bacterial, mycobacterial, fungal and viral infections have occurred. Regularly monitor patients for infection and manage it promptly.
• Non-melanoma Skin Cancers: Basal cell and squamous cell carcinoma have occurred. Perform periodic skin examinations during treatment and following treatment as appropriate.
• Thrombosis: Thromboembolic events have occurred.
• Cytopenias: Thrombocytopenia, anemia, neutropenia, lymphopenia, and leukopenia have occurred. Perform CBC monitoring as clinically indicated.