b'IMPORTANT SAFETYMORTALITY THROMBOSIS Lipid ElevationsINFORMATION (continued) Higher rate of all-cause mortality,Thrombosis, including deep venousTreatment with oral ruxolitinib has SERIOUS INFECTIONS including sudden cardiovascularthrombosis, pulmonary embolism,been associated with increases in lipid No cases of active tuberculosisdeath, has been observed inand arterial thrombosis has beenparameters including total cholesterol, (TB) were reported in clinical trialspatients treated with oral Janusobserved in patients treated withlow-density lipoprotein (LDL) with OPZELURA. Cases of active TBkinase inhibitors for inflammatoryoral Janus kinase inhibitors forcholesterol, and triglycerides. were reported in clinical trials ofconditions. inflammatory conditions. Many of theseAdverse Reactionsoral Janus kinase inhibitors usedMALIGNANCIES adverse reactions were serious andThe most common adverse reactions to treat inflammatory conditions.Lymphoma and other malignanciessome resulted in death. Patients with(1%) are nasopharyngitis (3%), diarrhea Consider evaluating patients forhave been observed in patientssymptoms of thrombosis should be(1%), bronchitis (1%), ear infection latent and active TB infection prior totreated with Janus kinase inhibitorspromptly evaluated. (1%), eosinophil count increased (1%), administration of OPZELURA. Duringfor inflammatory conditions. PatientsThromboembolic events were observedurticaria (1%), folliculitis (1%), tonsillitis OPZELURA use, monitor patientswho are current or past smokers arein clinical trials with OPZELURA.(1%), and rhinorrhea (1%).for the development of signs andat additional increased risk. Non- There was no clear relationship symptoms of TB. melanoma skin cancers, includingbetween platelet count elevations andPregnancyViral reactivation, including cases ofbasal cell and squamous cellthrombotic events. OPZELURA shouldThere will be a pregnancy registry herpes virus reactivation (e.g., herpescarcinoma, have occurred in patientsbe used with caution in patients whothat monitors pregnancy outcomes in zoster), were reported in clinical trialstreated with OPZELURA. Performmay be at increased risk of thrombosis.pregnant persons exposed to OPZELURA with Janus kinase inhibitors usedperiodic skin examinations duringduring pregnancy. Pregnant persons to treat inflammatory conditionsOPZELURA treatment and followingThrombocytopenia, Anemia andexposed to OPZELURA and healthcare including OPZELURA. If a patienttreatment as appropriate. Neutropenia providers should report OPZELURA develops herpes zoster, considerThrombocytopenia, anemia andexposure by calling 855-4MEDINFO or interrupting OPZELURA treatmentMAJOR ADVERSE CARDIOVASCULARneutropenia were reported in the855-463-3463.until the episode resolves. EVENTS (MACE) clinical trials with OPZELURA. ConsiderLactationHigher rate of MACE (includingthe benefits and risks for individualAdvise women not to breastfeed during Hepatitis B viral load (HBV-DNA titer)cardiovascular death, myocardialpatients who have a known historytreatment with OPZELURA and for four increases, with or without associatedinfarction, and stroke) has beenof these events prior to initiatingweeks after the last dose (approximately elevations in alanine aminotransferaseobserved in patients treatedtherapy with OPZELURA. Perform CBC5 elimination half-lives).and aspartate aminotransferase,with Janus kinase inhibitors formonitoring as clinically indicated. If have been reported in patients withinflammatory conditions. Considersigns and/or symptoms of clinically chronic HBV infections taking oralthe benefits and risks for the individualsignificant thrombocytopenia, anemia, ruxolitinib. OPZELURA initiation is notpatient prior to initiating or continuingand neutropenia occur, patients should recommended in patients with activetherapy with OPZELURA, particularlydiscontinue OPZELURA. hepatitis B or hepatitis C. in patients who are current or past smokers and patients with other cardiovascular risk factors. PatientsPlease see Brief Summary of Full Prescribing Information on the following pages.should be informed about the symptoms of serious cardiovascular References: 1. OPZELURA (ruxolitinib) cream. Prescribing Information. Incyte Corporation; 2021. 2. Papp K et al. J Am Acad events and the steps to take if theseDermatol. 2021;85:863-872.symptoms occur. OPZELURA is a trademark of Incyte. Incyte and the Incyte logo are registered trademarks of Incyte.2021, Incyte Corporation. MAT-ONA-0017809/21'