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Opzelura
ruxolitinib topical
Black Box Warnings .
Serious Infections
incr. risk of serious infection leading to hospitalization or death in patients treated w/ oral JAK inhibitors for inflammatory conditions; pulmonary and extrapulmonary TB, invasive fungal infections, and other opportunistic infections reported in patients treated w/ oral JAK inhibitors for inflammatory conditions; serious lower respiratory tract infections and viral reactivation, incl. herpes zoster, reported w/ topical ruxolitinib; consider screening for latent and active TB infection before tx; avoid use in patients w/ active, serious infection, incl. localized infections; weigh risk/benefit before tx in patients w/ chronic or recurrent infection; monitor closely for infection signs/symptoms during and after tx; D/C topical ruxolitinib if serious infection or sepsis develops
Mortality
higher rate of mortality, incl. sudden cardiovascular death, observed in RA patients 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers in a large, randomized, post-marketing study; topical ruxolitinib not approved for use in RA patients
Malignancies
non-melanoma skin CA occurred in patients treated w/ topical ruxolitinib; lymphoma and other malignancies observed in patients treated w/ oral JAK inhibitors for inflammatory conditions; higher rate of malignancies, excluding non-melanoma skin CA, observed in RA patients treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in patients w/ known malignancy, patients who develop a malignancy during tx, or patients who are current or past smokers; topical ruxolitinib not approved for use in RA patients
Major Adverse Cardiovascular Events
higher rate of major adverse cardiovascular events, incl. cardiovascular death, non-fatal MI, and non-fatal stroke, observed in RA patients 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; incr. risk in current or past smokers; weigh risk/benefit in patients who are current or past smokers or patients w/ other cardiovascular risk factors; D/C topical ruxolitinib in patients that experienced MI or stroke; topical ruxolitinib not approved for use in RA patients
Thrombosis
thromboembolic events observed w/ topical ruxolitinib tx; incr. incidence of thrombosis, incl. DVT, PE, and arterial thrombosis, reported in patients treated w/ oral JAK inhibitors for inflammatory conditions; many adverse events were serious, sometimes fatal; higher rate of thrombosis observed in RA patients 50 yo and older w/ at least 1 cardiovascular risk factor treated w/ an oral JAK inhibitor (tofacitinib) vs. TNF blockers; avoid topical ruxolitinib in patients at incr. thrombosis risk; D/C topical ruxolitinib and promptly evaluate patients w/ thrombosis symptoms; topical ruxolitinib not approved for use in RA patients
Adult Dosing .
Dosage forms: CRM: 1.5%
mild-moderate atopic dermatitis, short-term tx or intermittent long-term tx
- [apply bid]
- Max: 60 g/wk,100 g/2wk; Info: for immunocompetent patients; tx area should not exceed 20% BSA; reassess if no improvement in 8wk
vitiligo, non-segmental
- [apply bid]
- Max: 60 g/wk,100 g/2wk; Info: tx area should not exceed 10% BSA; reassess if unsatisfactory response in 24wk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: CRM: 1.5%
mild-moderate atopic dermatitis, short-term tx or intermittent long-term tx
- [2-11 yo]
- Dose: apply bid; Max: 60 g/2wk; Info: for immunocompetent patients; tx area should not exceed 20% BSA; reassess if no improvement in 8wk
- [12 yo and older]
- Dose: apply bid; Max: 60 g/wk,100 g/2wk; Info: for immunocompetent patients; tx area should not exceed 20% BSA; reassess if no improvement in 8wk
vitiligo, non-segmental
- [12 yo and older]
- Dose: apply bid; Max: 60 g/wk,100 g/2wk; Info: tx area should not exceed 10% BSA; reassess if unsatisfactory response in 24wk
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- infection, active
- thrombosis risk
- avoid: breastfeeding during tx and x4wk after D/C
- caution: infection risk
- caution: infection, chronic
- caution: infection, recurrent
- caution: opportunistic infection history
- caution: TB infection, latent
- caution: TB infection risk
- caution: herpes zoster history
- caution: HBV infection
- caution: HBV infection history
- caution: HCV infection
- caution: malignancy
- caution: cardiovascular disease
- caution: cardiovascular disease risk
- caution: smokers
- caution: past smokers
Drug Interactions .
Overview
ruxolitinib topical
JAK inhibitor topical
- CYP3A4 substrate
- immunomodulatory effects
- myelosuppressive effects
- thrombogenic effects
Contraindicated
- BCG live intravesical
- talimogene laherparepvec
Avoid/Use Alternative
- abatacept
- abrocitinib
- adagrasib
- adalimumab
- aldesleukin
- alemtuzumab
- anakinra
- anifrolumab
- anti-thymocyte globulin
- atazanavir
- axicabtagene ciloleucel
- azathioprine
- baricitinib
- basiliximab
- belatacept
- belimumab
- blinatumomab
- brentuximab vedotin
- brexucabtagene autoleucel
- brodalumab
- canakinumab
- ceritinib
- certolizumab pegol
- chloramphenicol
- cladribine oral
- clarithromycin
- cobicistat
- crovalimab
- daratumumab
- deferiprone
- delgocitinib topical
- deucravacitinib
- deuruxolitinib
- dinutuximab
- dupilumab
- eculizumab
- efgartigimod alfa
- elotuzumab
- elranatamab
- emapalumab
- epcoritamab
- etanercept
- etrasimod
- everolimus
- fexinidazole
- ganciclovir
- gemtuzumab ozogamicin
- glofitamab
- golimumab
- guselkumab
- ibritumomab tiuxetan
- idecabtagene vicleucel
- idelalisib
- inebilizumab
- infliximab
- inotuzumab ozogamicin
- isatuximab
- itraconazole
- ixekizumab
- ketoconazole
- lebrikizumab
- levoketoconazole
- lisocabtagene maraleucel
- lonafarnib
- loncastuximab tesirine
- lopinavir/ritonavir
- lymphocyte immune globulin, anti-thymocyte globulin
- mifepristone
- mogamulizumab
- mycophenolate mofetil
- mycophenolic acid
- natalizumab
- nefazodone
- nelfinavir
- nipocalimab
- obecabtagene autoleucel
- obinutuzumab
- ocrelizumab
- ofatumumab
- pacritinib
- penicillamine
- pimecrolimus topical
- polatuzumab vedotin
- posaconazole
- pozelimab
- primaquine
- ravulizumab
- ribociclib
- rilonacept
- risankizumab
- ritlecitinib
- ritonavir
- rituximab
- ropeginterferon alfa-2b
- rozanolixizumab
- ruxolitinib
- sarilumab
- satralizumab
- secukinumab
- siltuximab
- sirolimus
- spesolimab
- sutimlimab
- tacrolimus
- tafasitamab
- talquetamab
- tarlatamab
- teclistamab
- teplizumab
- tildrakizumab
- tipranavir
- tisagenlecleucel
- tocilizumab
- tofacitinib
- tralokinumab
- tucatinib
- ublituximab
- upadacitinib
- ustekinumab
- vaccinia immune globulin
- valganciclovir
- vedolizumab
- vilobelimab
- voclosporin
- voriconazole
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- ado-trastuzumab emtansine
- afamitresgene autoleucel
- aflibercept
- albendazole
- allopurinol
- aminocaproic acid
- angiotensin II
- anthrax immune globulin
- anti-inhibitor coagulant complex
- antihemophilic factor (factor VIII)/von Willebrand factor complex
- aprepitant
- arsenic trioxide
- asciminib
- asenapine
- asparaginase
- atidarsagene autotemcel
- auranofin
- avacopan
- avatrombopag
- axitinib
- azacitidine
- balsalazide
- bazedoxifene
- belantamab mafodotin
- belinostat
- bendamustine
- benznidazole
- berotralstat
- betibeglogene autotemcel
- bevacizumab
- bexarotene
- binimetinib
- bortezomib
- bosutinib
- botulism immune globulin
- brolucizumab
- busulfan
- C1 esterase inhibitor
- cabazitaxel
- cabozantinib
- calaspargase
- capecitabine
- carboplatin
- carfilzomib
- carmustine
- celecoxib
- chlorambucil
- chorionic gonadotropin
- cidofovir
- ciltacabtagene autoleucel
- ciprofloxacin
- cisplatin
- cladribine injection
- clofarabine
- clofazimine
- clozapine
- coagulation factor IX
- coagulation factor VIIa
- colchicine
- concizumab
- conivaptan
- copanlisib
- crizotinib
- cyclophosphamide
- cyclosporine
- cytarabine
- cytomegalovirus immune globulin
- dacarbazine
- dactinomycin
- danazol
- dapsone
- darbepoetin alfa
- darunavir
- dasatinib
- daunorubicin
- decitabine
- deferasirox
- deflazacort
- desogestrel (contraceptive)
- dexamethasone
- dexrazoxane
- diclofenac
- diclofenac topical
- dienogest (contraceptive)
- diflunisal
- diltiazem
- docetaxel
- dostarlimab
- doxorubicin
- dronedarone
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- duvelisib
- eflornithine
- elivaldogene autotemcel
- eltrombopag
- enfortumab vedotin
- entrectinib
- epirubicin
- epoetin alfa
- eribulin
- erythromycin
- estetrol (contraceptive)
- estradiol (contraceptive)
- estradiol (hormone replacement)
- estrogens, conjugated (hormone replacement)
- estrogens, esterified (hormone replacement)
- ethinyl estradiol (contraceptive)
- ethinyl estradiol (hormone replacement)
- ethynodiol (contraceptive)
- etodolac
- etonogestrel (contraceptive)
- etoposide
- exagamglogene autotemcel
- factor XIII concentrate
- fam-trastuzumab deruxtecan
- faricimab
- fedratinib
- fenofibrate
- fenofibric acid
- fenoprofen
- fitusiran
- floxuridine
- fluconazole
- flucytosine
- fludarabine
- fluorouracil
- fluphenazine
- flurbiprofen
- follitropin
- fosamprenavir
- foscarnet
- fostamatinib
- fruquintinib
- gemcitabine
- givinostat
- glasdegib
- hepatitis B immune globulin
- hydroxychloroquine
- hydroxyurea
- ibrutinib
- ibuprofen
- idarubicin
- ifosfamide
- imatinib
- imetelstat
- immune globulin
- indomethacin
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- iohexol
- iomeprol
- iopamidol
- irinotecan
- isavuconazonium
- ivosidenib
- ixabepilone
- ketoprofen
- ketorolac
- lazertinib
- lefamulin
- leflunomide
- lenacapavir
- lenalidomide
- lenvatinib
- letermovir
- levonorgestrel (contraceptive)
- levonorgestrel (hormone replacement)
- lifileucel
- linezolid
- linvoseltamab
- lomustine
- lovotibeglogene autotemcel
- lumateperone
- lurbinectedin
- luspatercept
- lusutrombopag
- lutetium Lu 177 dotatate
- lutetium Lu 177 vipivotide tetraxetan
- meclofenamate
- medroxyprogesterone (contraceptive)
- medroxyprogesterone (hormone replacement)
- megestrol
- meloxicam
- melphalan
- menotropins
- mercaptopurine
- mesalamine
- mesalamine rectal
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyltestosterone
- midostaurin
- mitomycin
- mitotane
- mitoxantrone
- momelotinib
- mosunetuzumab
- nabumetone
- naproxen
- necitumumab
- nelarabine
- netupitant
- nilotinib
- nintedanib
- niraparib
- nirogacestat
- norelgestromin (contraceptive)
- norethindrone (contraceptive)
- norethindrone (hormone replacement)
- norgestimate (contraceptive)
- norgestrel (contraceptive)
- olaparib
- olsalazine
- ospemifene
- oxaliplatin
- oxaprozin
- paclitaxel
- palbociclib
- panobinostat
- pazopanib
- pegaspargase
- peginterferon alfa 2a
- peginterferon beta 1a
- pemetrexed
- pentamidine
- pentostatin
- piroxicam
- pirtobrutinib
- pomalidomide
- ponatinib
- porfimer
- pralatrexate
- procarbazine
- progesterone (hormone replacement)
- progesterone vaginal (hormone replacement)
- proguanil
- prothrombin complex concentrate (human)
- pyrimethamine
- quizartinib
- radium Ra 223 dichloride
- raloxifene
- ramucirumab
- ranibizumab
- Rho(D) immune globulin
- ribavirin
- rifabutin
- rilzabrutinib
- romidepsin
- romiplostim
- rucaparib
- sacituzumab govitecan
- segesterone (contraceptive)
- selinexor
- sipuleucel-T
- sirolimus albumin-bound
- sodium tetradecyl sulfate
- sotatercept
- stiripentol
- streptozocin
- succimer
- sulfasalazine
- sulindac
- tagraxofusp
- talazoparib
- tazemetostat
- temozolomide
- temsirolimus
- teriflunomide
- testosterone
- thalidomide
- thioguanine
- thiotepa
- tivozanib
- topotecan
- toremifene
- trabectedin
- trastuzumab
- treosulfan
- tretinoin
- trifluridine
- trimethoprim
- vadadustat
- valoctocogene roxaparvovec
- valproic acid
- vamorolone
- vancomycin
- varicella zoster immune globulin
- venetoclax
- verapamil
- vinblastine
- vincristine
- vinorelbine
- von Willebrand factor
- vorinostat
- zanubrutinib
- zidovudine
- ziv-aflibercept
- zopapogene imadenovec
Caution Advised
- beclomethasone inhaled
- beclomethasone nasal
- betamethasone
- bimekizumab
- budesonide
- budesonide inhaled
- budesonide nasal
- budesonide rectal
- clobetasol ophthalmic
- coccidioides immitis skin test antigen
- corticotropin
- cortisone
- danicopan
- dexamethasone ophthalmic
- difluprednate ophthalmic
- dimethyl fumarate
- diroximel fumarate
- fingolimod
- fludrocortisone
- flunisolide nasal
- fluocinolone intravitreal
- fluorometholone ophthalmic
- fluticasone furoate
- fluticasone propionate
- hydrocortisone
- hydrocortisone ophthalmic
- iptacopan
- loteprednol ophthalmic
- methylprednisolone
- mirikizumab
- mometasone implant
- mometasone inhaled
- mometasone nasal
- monomethyl fumarate
- nadofaragene firadenovec intravesical
- ozanimod
- pegcetacoplan
- ponesimod
- prednisolone
- prednisolone ophthalmic
- prednisone
- regorafenib
- siponimod
- triamcinolone
- tuberculin purified protein derivative
- zilucoplan
Adverse Reactions .
Serious Reactions
- infection, serious
- opportunistic infection
- viral reactivation
- HBV reactivation
- herpes zoster
- thrombocytopenia
- anemia
- neutropenia
- lymphopenia
- leukopenia
- non-melanoma skin CA
- thromboembolism
Common Reactions
- URI
- application site rxn
- nasopharyngitis
- headache
- fever
- WBC decr.
- UTI
Safety/Monitoring .
Monitoring Parameters
CBC w/ diff; dermatologic exams periodically during tx and after tx D/C; signs/symptoms of serious infection during and after tx D/C; consider HBV, HCV, TB screening at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; inadequate human data available; no known risk of teratogenicity, though risk of fetal death based on animal data w/ PO route at 0.7x MRHD; risk of decr. fetal weight based on animal data w/ PO route at 0.7x and 22x MRHD
Pregnancy Registry
enroll patients or encourage patients to enroll in Pregnancy Exposure Registry at 1-855-463-3463 or www.opzelura.pregnancy.incyte.com
Lactation
Clinical Summary
avoid breastfeeding during tx and x4wk after D/C; no human data available to assess risk of infant harm, though possible drug excretion into milk based on drug properties; no human data available to assess effects on milk production
Pharmacology .
Metabolism: liver; CYP450: 2C9, 3A4 (primary) substrate; Info: active metabolites; systemic absorption varies w/ application area and site, tx duration, and patient-specific factors
Excretion: urine 74%, feces 22%; Half-life: 116h
Subclass: Atopic Dermatitis, Topical Nonsteroidal Agents ; Cosmetic, Dermatologic ; Immunosuppressants ; JAK Inhibitors, Dermatologic
Mechanism of Action
exact mechanism of action unknown; inhibits janus-associated kinases (JAK) 1 and 2, leading to disruption of cytokine and growth factor signaling pathways
Formulary .
No Formulary Selected
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