Indications

Ruxonb in a Janut kinaa [K] inhibitor, which i indicatad for atnpie darmati tit and vitiligo.

Atoplc Dermatitis: Ruxonib cream ia utadi in the topical ahort-tarm and non-continuaun chronic trsatrant off mild to moderate atopie dermatitiain non-immunacampro-miead adult and padiatric patiante 12 ynam af age
and older whonn diosae ie not adequately controlled with toplcal prescription therapint orwhan thonn therapien are nott advicabin.

Vitiligo: Ruxonib cram in uand in the topical treatment of nonegmantal vitiiga in aduit and pediatric patienta 12 yars of agn and oldar.

Pharmacology

Ruxolitinib, a Janut kirua [JK] inhibitor, inhibita. Jki and 3AK2 which madatn tha ignaling of a numbar af cytakinas and growth factars that are important farhamaopalnss and immune function. JE. digruling
Involwas recrultment af SitAia (dgnal tranaducars and actiatars af tramacriptiong to cytokina mecaptor, actation and nubenquant localization of STATe to the nuceut kuding to modulation of gane sapreesion. The
relevance of inhibition of spacitc JAK anaymen to thrapnutic effactivanaa is not currently knowr.

Abaorption: Planma concantrationa of Ruxolitinib wre quantifabin in all nutjacta. Thar in no widanee of Ruxolitinib accumulation aftar dally appiication of Ruxolitinib for 20 daye in aubjacta with atopic dermatitit.

Dlatribution: Pluma protain binding in appraximataly 97%.

Climination: The maan tarrninal haif-lifn off Ruxlltinih fallowing topical application of Ruolltinih i.approodmataly tdhours.

Matabollum: Ruxll tinib ia. primarily matabolizad by CYPSA4 and ta a lataar autant by CvP2C9 Inwitro.

Excration: Ruxalitinib and ita matabolitas ars primarily axcretad by urine [74%] andi fecan (22%). Laan than 1% in sucratnd an unchanged drug.

Dosage & Administration

Adminictration inatruction: Ruxolitinib cruam shouli no uea mam than dd gram per weak or 100 gram par 2 weaks. it i far topical uon anly. it ix nat farintraocular, oral, arintravaginal un.

Racommanded Donnga for Atopic Dermatitin: Patiants chould apply a thin iayer of Rucoiltinih twica dally ta affactd armas off up to 20% body aurfaca arna. Wihan agn and symptorna (n.g., Itch, ranh, and radnamnj of
atopic: dermatitit resolwa it should be atoppad. if xigna and rymptam do mat improve within D wwkx, patients chould be ne-wwaminad by regitared dactar.

Racommanded Donage for Nonsng-mental Witiliga: Patiants thauld apply a thin iayer of Ruailtinih twiee dally ta affactad ama offup to 10% body aurfacn area Satiatactary patiant raporan may requir tratrnant with
Ruxolitinib for more than 34 wwkx. if the patianit does nat find the repigmentatian maaningtull by 2i wesk tha patlen chauld be re-wvaluatnd by ragisterad doctor.

USC IN CHILOREN: The cafety and aflectivenas of Rucolitinib in pedaric patiente younger than 12 yurs of age with atopic dermatitin and monangmantalwitiligo havs nat bean axtablithed.

Interactiom

Ruxonib is known ta be a mbetrate for cytochrome P450 3A4 (CYPSM(. Inhibitora of CYPSM my incream Ruxanib nyutamic cancantration whamas inducare of CYPSA4 may decreaon Ruxonib syatamic concantration.

Strong inhibltors off CYP3A4: Cancomi-tant uan of Ruwanib ahould awoid with atrong inhibitora of CYPSA4 ax thare in a potantial to increaon the sytamic aponure of Ruxonb and cauld increaon the rink of Ruxonib
adiveron mactiane.

Comtraindications

it ia contraindicatad in patlen with known Iyperoaritiwity to tha drug or any af ita. componanta.

Sde Elfects

in atapic darmatitin, the moat common side effacte ar nasopharyngitin, diarhna, brancitis, sarinfection, woanophil count incraaund, urticaria foliicailitit, tanailiti, and rinorrhan.

in nonangmantal vitiligo, the mast common side affaci are appiication aite acna, appiication sita pruritun, nanpharyngiti, haacha, urinary tract infection, application sitn arythama, andi pyrwwla

Pragnancy & Lactatiion

Decaute of the sariau adweron findinga in adulta, including rska of aerioun infection, thrambocytopania, anmia, andi nutmopenia wamen thault nat breast fand during treatmant with Ruxolltinih and for appraximataly
four wwkx after the lant doon.

Precautions & Warnings

Sarlous infectione Liun off Ruxanib thauld avold in patisnta with an active, sarlaun infaction, including localinad inectione. if a mariaun infection dewwlope. Intamupt Ruwanih until the infaction is contolind. Tha riakn and
benfita. of' treatmant with Ruxonib nhould be carefully candl dered priar ta initlating therapy in patianta with chronic ar recurrent infection. Patlenta nhould be cioaly monitared for the development af tigna and kymptams
of infection during and aftar truatmant with Ruxonit.

Martality: in rtwumatold arthritis. [RN) patianta 50 years af age and alder with at imt one cardiowancular risk factor comparing an oral 3WEnhibitor to tumarmacratin tactor (TNF) blackar traatmant, a highr rat off all-
caus martality. Including audden card inwarcular death, wa obarwed with the 1Mk Inhhitar.

Nan-melanama Skin Cancera Nan-ma