b'NOW APPROVED OPZELURA CAN BE APPLIED TO AFFECTED SKIN, For your non-immunocompromised members with uncontrolled11 UP TO 20% BSA, INCLUDING SENSITIVE SKIN AREAS*mild to moderate atopic dermatitis (AD) 12 years of age and olderTHE ONLY FDA-APPROVED JAK INHIBITOR IN A CREAM FORMULATION 1 * For topical use only. Not for ophthalmic, oral, or intravaginal use.IN THE TRuE-AD1 AND TRuE-AD2 CLINICAL TRIALS,Learn more about the clinical studies PATIENTS RECEIVING OPZELURA DEMONSTRATED MEANINGFUL RESULTS FOR 1,2 for OPZELURA at OPZELURAhcp.com.SKIN CLEARANCE INDICATIONAs measured by Investigators OPZELURA is indicated for the topicalActive tuberculosis, which may short-term and non-continuous chronicpresent with pulmonary or Global AssessmentTreatment Success treatment of mild to moderate atopicextrapulmonary disease. (IGA-TS [primary endpoint]) dermatitis in non-immunocompromisedI nvasive fungal infections, including patients 12 years of age and older whosecandidiasis and pneumocystosis. disease is not adequately controlled withBacterial, viral, and other infections ITCH REDUCTION topical prescription therapies or whendue to opportunistic pathogens.those therapies are not advisable. Avoid use of OPZELURA in patients As measured by 4-point improvementLimitation of Use: with an active, serious infection, in Itch Numeric Rating Scale (Itch-NRS 4) Use of OPZELURA in combination withincluding localized infections. If a therapeutic biologics, other JAK inhibitorsserious infection develops, interrupt or potent immunosuppressants suchOPZELURA until the infection is SAFETY AND TOLERABILITY as azathioprine or cyclosporine is notcontrolled. Carefully consider the recommended. benefits and risks of treatment prior The most common adverse reactions, occurringto initiating OPZELURA in patients in 1% of patients treated with OPZELURA, wereIMPORTANT SAFETY INFORMATION with chronic or recurrent infection. nasopharyngitis, diarrhea, bronchitis, ear infection,SERIOUS INFECTIONS Closely monitor patients for the eosinophil count increased, urticaria, folliculitis,Patients treated with oral Janus kinasedevelopment of signs and symptoms tonsillitis, and rhinorrhea inhibitors for inflammatory conditions areof infection during and after treatment at risk for developing serious infectionswith OPZELURA.that may lead to hospitalization or death.OPZELURA was studied in 2 identically designed, phase 3, double-blind, randomized, 8-week, VC trialsReported infections include:(TRuE-AD1 and TRuE-AD2). The clinical trials included 1,249 adolescent and adult patients with AD 12 yearsof age and older (631 randomized in TRuE-AD1 [vehicle, n=126; OPZELURA 1.5%, n=253] and 618 randomized Please see additional Important Safety Information on following page.in TRuE-AD2 [vehicle, n=118; OPZELURA 1.5%, n=228]). At baseline, patients had an affected BSA of 3% to 20%and an IGA score of 2 or 3 on a 0- to 4-point severity scale. The primary endpoint was IGA-TS, defined as anPlease see Brief Summary of Full Prescribing Information on the following pages.IGA score of 0 or 1 with 2-grade improvement from baseline, and Itch-NRS 4 was a key secondary endpoint.BSA, body surface area; FDA, Food and Drug Administration; IGA, Investigators Global Assessment; IGA-TS, Investigators Global The Itch-NRS 4 analysis included patients with an Itch-NRS score 4 at baseline (TRuE-AD1 [vehicle, n=78;AssessmentTreatment Success; Itch-NRS, Itch Numeric Rating Scale; Itch-NRS 4, 4-point improvement from baseline in Itch OPZELURA 1.5%, n=161]; TRuE-AD2 [vehicle, n=80; OPZELURA 1.5%, n=146]). 1,2 Numeric Rating Scale; JAK, Janus kinase; TRuE-AD, Topical Ruxolitinib Evaluation in AD; VC, vehicle-controlled.'