Indications

Vitigo le a Jarut kinaun (7AK) inhibltar, which it indicated for atople dermalitin.and vitilga.

Atoplc Dermatitie: Vitigo cream ix utd in the toplea short-tar and non-continuous cronle traatrant of mild to modarate atople darmalitis. In non-immunacampro-mned adult and padatre patante 12 yuar af age
and older whoss diossss it no adequately controlied with topleal prescription tharapies or whan thoes tharapies are not advable.

Vitiligo Visgo cream lwwaed in tha topleal treatmant of nonagmantal vitliga in adult and pediaic patiarts 12 yaars of aga and older.

Pharmacology

Ruxolitinib, a Janut kira [OK] inhibitor, inhibits 2/ and 2002: whic madiat tha tigraling of anumbaraf cytakinas and growth factars that are importan farhamatopalas and immur function. 2E sigraling
Involvwe recrulmant af STATe [eignal transducars and actatars af transeription) to cytokina recsptore, activation and subenquant localizaon of STNTe to the mucut lading to moculation of gana aspresson. The
relavance of inhibition of spacic aAK ansymes to tharapaue affactivanass it not currently known.

Abeorption: Plaema concantratione of Ruxolitinb wwre quantifable in all nubjecte. Thars ls no wvidence of Ruxolitinis accumuation after dally application of Ruxolitinib for 20 days in subjacte with anople derrnatitit.

Dirtribution: Pisma protein binding it appradmabaly 97%.

Climinaten The maan tarrinl haif-life of Ruslltinb fallowing toplcal application of Ruiltin in.approodmataly Hdihoure.

Matabolium: Ruxziltinib l primarily mataboliaed by CYPSA4 and ts a lasar astant by CYP2C9 Imwitro.

Exeretian: Ruiltinb and ite matabolites ars primarly wxcreted by urine [74%] and fecas [22%]. Laes than f% le eacrwied as nchanged drug.

Dosage & Administration

Adminirtration instruction Ruxolitinis eream should not us man than do gram par wenk or 100 gram par 2 weeks. i in far topical uns anly. it it nat far iintraocuar, oral, arintravaginl us.

Rscommanded Donaga for Atopic Dermatitis: Patlants thould apply a thin layer of Ruomitinib twice daly is affacted arse of up to 20% body surfacs arsa. Vhan aigne and syrptorne jag. itch, rash, and radnasn) of
atopic dermatitix rucoln it should be atoppad. if tigne and symptame do not improve within D wks, patlants should ba ne-esaminad by rglstarnd dactar.

Ascommanded Donags for Nonsag-mantal Vitiligo: Palents thould apply a thin layer of Rusiinib twce dally is affactad amas of up to 10% body suraen area. Satiafactary patant reaporus may require traatrant with
Auxolitinlb for more than 34 wenks. if the patlan does not find the raplgmartatian masningfu by 24i weske, the patiant should bene-avaluatad by regleered doctor.

USC IN CHILOREN: Tha safety and affectiveres of Rucolitinb in padatric patiare younger than 12 yaars of age with alople derratitix and nonangmentalwitiligo aen not baan astablithad.

nteraction

Vitigo ie known to ba a subetrate far cytachrama P450 3/ [CYPS/], Inhibltors of CYPSA4 may Inereaos Vitiga systamic concantratione wharsat inducars of CYPSA4 may dacreans Mtiga syatarnic concanratione.

Strong Inhibltors of CYPSM: Cancoml-tant us of Vitigo should awoid with atrong inhibitors of CYPSMi an than is a pobardal to inersaoe the systamic eaposurs of Vitigo and could inereaos the ritk of Vitigo adverns
mactiorit

Contraindications

it it contraind cated in patlerde with known lypersandltwity to the drug or any af ts. corponant.

Side Etfects

In atapic drmatiie, the moat common side affacte are natopharyngitie, diarhea, branchitie, sarindection, scalnophil countinerwusd urticarla, folllcuitie, taneiiite, and hinorrhas.

in noragmantal visligo, the most common tide affecte are application site acna, application site pruritus, raspharyngitis, haadache, urinary tract infection, application sibe arythama, and pyreala

Pregnancy & Lactatiion

Decsun of the sarloun adweroe finding In adulte, including dke off sarlous infection, theambocytopana, anmia, and rutropania, waman thould nat breastfend during treatmand with Ruxolitinh and for appnxmataly
four wwskx after the latt daos.

Precautions & Warnings

Sarlous infectione Lite of Vitiga thould avold in patlents with an actien, narioun indaction, Including localinad inactione. if a narioun indection dawslope, intarupt Vitigo unt the infacon ix contralled. Tha riaks and bridita.
of treatmant with Viigo nhould ba carefully considered prior ts initiating tharapy iin patenta with chrone ar recurrent infecan. Patlanta nhoud ba closnly montared far the dwwlopmant of signa and symptame of
Infaction during and after traatman with Vitiga.

Mortality: in rhauratold arthriti (RA) patiants 50 ywars af age and older with at lesst ons cardiowaseular riak factor comparing an oral 2Winhlbitor to tumarmacrade factor [TNF) blacker treatmant, a highar ratn off all-
cause mortality. Including sudden card owaseuar daath, wan obuarved with tha 2AK inhbltor.

Non-malanama Skin Cancane: Nan-mal-anama tiin cancar incuding batal call and squamous cal cardnoma can ba accumed in patients treated with Vitigo. Parlodic sn auaminationa nhould parform during Vitigo
tratmant. Exposure to sunlight and UV light should be limited bywwaring prstective clothing and uaing brsad-spactrum sunacnean.

Hajor Advarss Candlovancular Ewents (MACE): Patlants who are curren or past smokars ars at addional incnsaced risk of Major Adweran Cardiovascular Euant. Palsants who have aparienced a myocar- dial iindarction
or etrokn, Vitigo should be disconinund.

Thromboalt: Thromboambolic wventa were observed in trials with Vitigo. if sympam of thromboals. occur. Vitigo thould be diacontinund and traat apprapriataly.

Thrombocytopania, Anamia, and Nautrspenia: Thrambocytopania, anamia, and nutropana can ba accumed. Parfarm CDC monitoring at clinically iindicated.

Therapeutic Class

Pyrrolopyrimidinan

Storage Conditions

Stons alow 30'C In a dry place, away from sunlight & kaep out of rach of children.